[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Royal Marsden NHS Foundation Trust\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":642},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,44,0,25,[9,46,76,102,134,162,184,219,240,259,278,306,332,352,388,412,433,460,481,509,527,549,569,591,621],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100644797","clinical-utility-of-ctdna-in-detecting-resistance-mechanisms-and-delivering-precision-medicine-to-cancer-patients-100644797",false,"NCT07673861","Clinical Utility of ctDNA in Detecting Resistance Mechanisms and Delivering Precision Medicine to Cancer Patients","Clinical Utility of ctDNA in Detecting Resistance Mechanisms and Delivering Precision Medicine: A Tumour Agnostic Study","CURTAIN","Inclusion Criteria\n\nAll cohorts:\n\n* Age ≥18 years old\n* Ability to provide written informed consent\n* Presence of metastatic or unresectable disease\n* Being reviewed and treated through medical oncology service at Royal Marsden Hospital\n\nCohort 1: Locally Advanced\u002FMetastatic NSCLC\n\n* Oncogene-addicted NSCLC (i.e. ESCAT Tier 1 oncogenic drivers: EGFR\u002FALK\u002FROS1\u002FRET\u002FMET\u002FBRAF\u002FNTRK\u002FHER2\u002FKRAS), AND\n* Progressive disease on targeted therapy (any line) within the 6 weeks prior to consent\n\nCohort 2: Locally Advanced\u002FMetastatic GIST\n\n* Locally advanced\u002Fmetastatic gastrointestinal stromal tumour (GIST), AND\n* Progressive disease on targeted therapy (any line) within the 6 weeks prior to consent\n\nCohort 3: Metastatic Colorectal Cancer\n\n• Metastatic colorectal cancer, left sided, RAS wild type, HER2 any status, AND\n\n* If HER2 negative or unknown: progressive disease on systemic anti-cancer therapy (SACT) with an anti-EGFR agent (e.g. cetuximab) within the 6 weeks prior to consent\n* If HER2 positive: progressive disease on first line systemic anti-cancer therapy (SACT) +\u002F- an anti-EGFR agent within the 6 weeks prior to consent\n\nCohort 4: Locally Advanced\u002FMetastatic BTC\n\n* Identified targetable mutation (IDH1 mutation\u002FHER2 amplification\u002FFGFR2 fusion or rearrangement\u002FNTRK fusion\u002FBRAF V600E mutation\u002FMMR deficiency \\[dMMR\\]), AND\n* Progressive disease on targeted therapy (any line) demonstrated within the 6 weeks prior to consent\n\nCohort 5: Advanced\u002FMetastatic ovarian cancer\n\n* Diagnosis of advanced\u002Fmetastatic high-grade ovarian cancer, AND\n* Known BRCA status, AND\n* Progressive disease on a PARP-inhibitor (with or without bevacizumab) following platinum-based therapy in the 1st line maintenance setting, within the 6 weeks prior to consent\n\nExclusion Criteria\n\nAll cohorts:\n\n* Medically unstable to commit to sampling required for the study\n* ECOG performance status ≥3","ALL","18 Years",{"count":21,"type":22},100,"ESTIMATED","INTERVENTIONAL",[25],"NA","ctDNA stands for circulating tumour DNA. As ctDNA is released by tumour cells into the blood stream, taking a blood sample and analysing it for ctDNA, can provide a lot of useful information about a patient's cancer. In certain situations, ctDNA can be used to screen for or detect cancer early, to aid clinical decisions about which treatment to give a patient, to provide information about if a cancer has become resistant to treatment, or provide information about how much cancer may be left after treatment (residual disease).\n\nThe aim of this trial is to establish the clinical utility of implementing ctDNA testing in cancer patients with a view to enhance the delivery of personalised care within the National Health Service in the United Kingdom (UK).\n\nOne hundred patients will be recruited, with 20 from each of the following cancer types:\n\n* Non-small cell lung cancer\n* Gastrointestinal stromal tumours\n* Colorectal cancer\n* Biliary tract cancer\n* Ovarian cancer.\n\nPatients must be aged 18 or over, must have had progressive disease whilst receiving anti-cancer treatment, and must be being treated at The Royal Marsden.\n\nPatients will have a blood sample taken and analysed using the Marsden360 ctDNA test. The results of the test will be looked at by The Royal Marsden Genomic Tissue Advisory Board (GTAB), and for each individual patient, the GTAB will determine if having a ctDNA test helped to personalise their care by:\n\n* Aiding the identification of a genomically-matched standard of care therapy\n* Aiding the identification of a genomically-matched clinical trial (based in the UK)\n* Offering additional prognostic information not otherwise available through standard of care testing\n* Negating the need for a tissue biopsy.",[28,29,30,31,32],"Non Small Cell Lung Cancer","Gastrointestinal Stromal Tumor (GIST)","Colorectal Cancer","Biliary Tract Cancer","Ovarian Cancer","RECRUITING","2026-06-24",{"date":36,"type":37},"2026-06-29","ACTUAL",{"date":39,"type":37},"2025-05-23",{"date":41,"type":22},"2026-12-31",{"name":43,"class":44},"Royal Marsden NHS Foundation Trust","OTHER",1,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":54,"minAge":19,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":45},"100644987","a-study-of-short-course-hypofractionated-online-adaptive-radiotherapy-for-the-post-operative-treatment-of-endometrial-cancer-tolerability-and-feasibility-100644987","NCT07675733","A Study of Short-course Hypofractionated Online-adaptive Radiotherapy for the Post-operative Treatment of Endometrial Cancer: Tolerability and Feasibility","Short-course Hypofractionated Online-adaptive Radiotherapy for the Treatment of ENdometrial Cancer","SHORTEN","Inclusion criteria\n\n1. Histologically confirmed endometrial carcinoma - inclusive of endometrioid adenocarcinoma, carcinosarcoma, clear cell carcinoma, serous carcinoma, dedifferentiated carcinoma, mucinous carcinoma, mixed carcinoma\n2. Age greater than 18 years old\n3. Disease fully resected at time of surgery\n4. Indication for post-operative external beam radiotherapy: high-intermediate risk and high-risk disease (ESGO-ESTRO-ESP guideline), or at the discretion of treating Clinical Oncologist\n5. If adjuvant systemic chemotherapy is indicated, participants will still be eligible for trial participation, provided there is a minimum 3-week gap between completing chemotherapy and beginning external beam radiotherapy\n6. If adjuvant vaginal vault brachytherapy boost is indicated, participants will still be eligible for trial participation, with a minimum gap of 1 day from completion of external beam radiotherapy to first fraction of brachytherapy\n7. WHO Performance Status 0 - 2\n8. Informed written consent\n\nExclusion criteria\n\n1. Previous pelvic radiotherapy\n2. Contraindication to receiving external beam radiotherapy\n3. Residual disease identified on post-operative imaging\n4. FIGO 2023 Stage 3C2 disease requiring extended para-aortic treatment field\n5. Hip prostheses or other metal work within the imaging field which would produce significant imaging artifact\n6. Indication for adjuvant concurrent chemo-radiotherapy","FEMALE",{"count":56,"type":22},30,[25],"The goal of this clinical trial is to assess the safety and feasibility of using a new form of radiotherapy technology, known as CT online-adaptive radiotherapy, to reduce the number of treatment sessions required in post-operative radiotherapy for patients with endometrial cancer, from 25 sessions over 5 weeks to 5 sessions over a week and a half.\n\nThe main questions it seeks to answer are:\n\n* If it is safe to deliver the radiotherapy in a smaller number of treatment sessions with a larger dose per session by utilising the CT online-adaptive technology\n* If it is feasible for this treatment to be delivered using the CT online-adaptive technology in a clinical trial All participants who enrol in the study would be offered the trial treatment of the radiotherapy being delivered in 5 sessions. Any potential participants who are subsequently found to be ineligible during the radiotherapy planning process would be excluded from the trial treatment of a higher dose over 5 sessions, but would still be offered the CT online-adaptive technology over 25 sessions outside of the trial.\n\nParticipants would undergo the trial treatment with the radiotherapy being delivered in 5 sessions over a week and a half using the CT online-adaptive technology, with any issues during the treatment delivery recorded, and a questionnaire to complete at the end of treatment to see how the new technology was tolerated by participants.\n\nParticipants will have their side effects recorded by the trial team before, during and after their treatment for 2 years following the radiotherapy. During this time period participants will also be asked to complete patient questionnaires to assess their perception of side effects and their quality-of-life after undergoing the treatment. Participants will also have blood tests before, during and after the radiotherapy for 3 months to check for any potential problems with blood counts as a result of the trial treatment.\n\nDuring the 2 years of follow-up after the radiotherapy, participants will also have assessments for if the cancer has returned, which will be completed by a combination of clinical examination, and CT scans.\n\nFollowing completion of the 2 years of trial follow-up, participants would remain on general follow-up to assess for if the cancer has returned, or for any longer term side effects for up to 5 years after the treatment, but this follow-up will be outside of the trial without the request for ongoing completion of participant questionnaires.",[60],"Endometrial Carcinoma (EC)",[62,63,64,65,66],"Online Adaptive Radiotherapy","Hypofractionation","Ultrahypofractionation","Endometrial","CT Online Adaptive Radiotherapy","NOT_YET_RECRUITING","2026-06-23",{"date":70,"type":37},"2026-06-30",{"date":72,"type":22},"2026-08",{"date":74,"type":22},"2030-05",{"name":43,"class":44},{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":86,"conditions":87,"keywords":92,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":45},"100568426","breast-cancer-evolution-during-neoadjuvant-systemic-therapy-100568426","NCT06681064","Breast Cancer Evolution During Neoadjuvant Systemic Therapy","BELIEVE","Inclusion Criteria:\n\n1. Histologically confirmed non-metastatic invasive breast cancer.\n2. Be suitable for, but have not commenced, neoadjuvant chemotherapy, targeted therapy, or immunotherapy.\n3. If HER2-, suitable for treatment with upfront taxane chemotherapy. If HER2+, suitable for treatment with anti-HER2 targeted therapy.\n4. Be aged 18 years and over.\n5. Have given written informed consent to participate.\n\nExclusion Criteria:\n\n1. Metastatic breast cancer at diagnosis.\n2. Treatment with neoadjuvant endocrine therapy only.\n3. Presence of any psychological, familial or sociological condition potentially hampering compliance with the study protocol and follow-up schedule.",{"count":84,"type":22},500,"OBSERVATIONAL","BELIEVE is a translational research study that aims to collect samples of breast cancer tissue and blood from individuals undergoing breast cancer treatment (such as chemotherapy, targeted therapy and immunotherapy) before surgery. In certain cases, MRI scans and stool samples will also be obtained before and during treatment. The samples collected from this study will be used for molecular and genetic research to understand why some cancers respond very well to anticancer treatments, and some do not, develop novel ways of accurately measuring response during treatment, as well as identify which patients are at a higher risk of the cancer coming back after surgery.",[88,89,90,91],"Breast Cancer","Triple Negative Breast Cancer","ER+ Breast Cancer","HER2+ Breast Cancer",[93],"Neoadjuvant Therapy","2026-04-13",{"date":96,"type":37},"2026-04-16",{"date":98,"type":37},"2024-05-29",{"date":100,"type":22},"2034-05",{"name":43,"class":44},{"id":103,"slug":104,"hasResults":12,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":23,"phases":112,"briefSummary":114,"conditions":115,"keywords":120,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},"100390210","phase-1-pavement-palbociclib-and-avelumab-in-metastatic-ar-triple-negative-breast-cancer-100390210","NCT04360941","PAveMenT: Palbociclib and Avelumab in Metastatic AR+ Triple Negative Breast Cancer","PAveMenT: Phase Ib Study of Palbociclib and Avelumab in Metastatic AR+ Triple Negative Breast Cancer","PAveMenT","Inclusion Criteria Part A:\n\n1. Patients with recurrent inoperable locally advanced or metastatic breast cancer.\n2. Previously treated with at least one prior line of chemotherapy for advanced disease, but no more than two prior lines of chemotherapy for advanced disease. Patients with ER+ breast cancer must have received at least one prior line of hormone therapy for advanced disease. Patients with HER2+ breast cancer must have received at least one prior line of HER2 directed therapy.\n3. Measurable disease (RECIST 1.1)\n4. Haematological and biochemical indices within the ranges stated in the study protocol. These measurements must be performed within one week (Day -7 to Day 1) before the patient goes in the trial.\n5. Women\u002Ffemale patients with child-bearing potential (defined as the fertile status following menarche and until becoming post-menopausal unless permanently sterile by methods that include hysterectomy, bilateral salpingectomy and bilateral oophorectomy) must have a negative urine or serum pregnancy test within 7 days prior to start of trial.\n\n   Women\u002Ffemales of child bearing potential or their male partners must use a highly effective method of contraception for 2 weeks before starting the study treatment, throughout the treatment period and for 1 month after discontinuation of treatment with palbociclib and avelumab (women\u002Ffemale patients) or 14 weeks (men\u002Fmale patients). Highly effective methods are defined as methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods, such methods include:\n   * Oral, intra-vaginal or transdermal combined hormonal contraception\n   * Oral, injectable or implantable progesterone-only contraception\n   * Intrauterine device\n   * Intrauterine hormone-releasing system,\n   * Bilateral tubal occlusion\n   * Vasectomised partner\n   * True abstinence:\\* When this is in line with the preferred and usual lifestyle of the subject\n\n   Key: \\* it is only considered highly effective if the patient is refraining from sexual intercourse during the entire period of risk associated with the study treatments\n6. 18 years of age or over.\n7. World Health Organisation (WHO) performance status 0 or 1\n8. Estimated life expectancy of at least 3 months in the opinion of the investigator\n9. Signed and dated informed consent.\n10. Patients willing and able to comply with scheduled visits, treatment plans, laboratory tests, follow up and other procedures\n\nInclusion Criteria Part B:\n\n1. Patients with recurrent inoperable locally advanced or metastatic AR+ triple negative breast cancer with ER, PgR and HER2 status determined locally and AR determined centrally on archival metastatic tissue. Archival tissue from the primary tumour (which must have been ER\u002FPgR negative and collected within 5 years prior to metastatic relapse) may be used for AR testing if no archival metastatic tissue is available.\n2. Previously treated with at least one prior line of chemotherapy for advanced disease, but no more than two prior lines of chemotherapy for advanced disease.\n3. Measurable disease (RECIST 1.1) amenable to fresh biopsy\n4. Haematological and biochemical indices within the ranges stated in the study protocol. These measurements must be performed within one week (Day -7 to Day 1) before the patient goes in the trial.\n5. Female patients with child-bearing potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial.\n\n   Women\u002Ffemales of child bearing potential or their male partners must use a highly effective method of contraception for 2 weeks before starting the study treatment, throughout the treatment period and for 1 month after discontinuation of treatment with palbociclib and avelumab (women\u002Ffemale patients) or 14 weeks (men\u002Fmale patients). Highly effective methods are defined as methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods, such methods include:\n   * Oral, intra-vaginal or transdermal combined hormonal contraception\n   * Oral, injectable or implantable progesterone-only contraception\n   * Intrauterine device\n   * Intrauterine hormone-releasing system,\n   * Bilateral tubal occlusion\n   * Vasectomised partner\n   * True abstinence:\\* When this is in line with the preferred and usual lifestyle of the subject\n\n   Key: \\* it is only considered highly effective if the patient is refraining from sexual intercourse during the entire period of risk associated with the study treatments\n6. Age 18 years of age or over\n7. World Health Organisation (WHO) performance status 0 or 1\n8. Estimated life expectancy of at least 3 months in the opinion of the investigator\n9. Signed and dated informed consent\n10. Patients willing and able to comply with scheduled visits, treatment plans, laboratory tests, follow up, and other procedures\n11. Available archival breast primary tumour tissue (or metastatic tissue if de novo metastatic disease)\n12. Patient willing to undergo a mandatory baseline fresh tumour tissue biopsy procedure (clinical or radiologically-guided)\n\nExclusion Criteria Parts A \\& B:\n\n1. Oral chemotherapy within two weeks, weekly iv chemotherapy within three weeks or any other systemic chemotherapy or investigational medicinal products during the previous four weeks.\n2. Hormonal therapy within 7 days except luteinizing hormone-releasing hormone (LHRH) analogues for ovarian suppression. Bisphosphonates or RANK ligand antagonists are permitted for the management of bone metastases.\n3. Previous exposure to immune checkpoint inhibitors or immune co-stimulatory drugs in the advanced setting. (Note: Patients who have received neoadjuvant and\u002For adjuvant pembrolizumab are eligible if treatment was completed at 6 months prior to metastatic relapse.)\n4. Previous treatment with palbociclib or any agents which inhibit CDK4\u002F6. (Note: Patients who have received adjuvant abemaciclib or ribociclib for early breast cancer are eligible if treatment was completed at least 12 months prior to metastatic relapse.)\n5. Major surgery (excluding minor procedures, e.g. placement of vascular access) within 4 weeks or radiation therapy within 14 days prior to study entry\n6. Patients with known symptomatic brain metastases requiring steroids, untreated brain metastases, leptomeningeal disease or spinal cord compression.\n7. Active infection requiring systemic therapy\n8. Any of the following within 12 months prior to study entry: myocardial infarction, history of myocarditis, uncontrolled angina, coronary\u002Fperipheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, or transient ischemic attack.\n9. Uncontrolled hypertension or cardiac dysrhythmia including atrial fibrillation\n10. Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.\n11. Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses ≤ 10 mg\u002Fday of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).\n12. Other severe acute or chronic medical conditions including colitis, inflammatory bowel disease, pneumonitis (even if fully resolved), pulmonary fibrosis, end stage renal disease on haemodialysis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behaviour; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.\n13. Patients on warfarin or direct acting oral anticoagulants. Patients requiring anticoagulation for rate-controlled AF or previous venous thromboembolism should be switched to low-molecular weight heparin.\n14. Known HIV or AIDS-related illness, active infection requiring systemic therapy, or positive HBV or HCV test indicating acute or chronic infection\n15. Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥ 3 NCI CTCAE v 5), any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma)\n16. Inability or unwillingness to swallow pills, or receive IV injections.\n17. Persisting toxicity related to prior therapy \\>Grade 1 (except for stable peripheral neuropathy grade ≤2 or alopecia grade ≤2).\n18. Pregnancy or lactation (women\u002Ffemales of childbearing potential must have a negative pregnancy test within 7 days prior to treatment initiation)\n19. Diagnosis of other malignancy within 3 years, except for previous breast cancer, adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix, or low-grade (Gleason ≤6) prostate cancer\n20. Is a participant or plans to participate in another interventional clinical trial, whilst taking part in this study. Participation in an observational trial would be acceptable.\n21. Known prior or suspected hypersensitivity to investigational products or to any of the excipients\n22. Vaccination within 4 weeks of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines. Live vaccines must also be avoided for 3 months after the last dose of avelumab.\n23. Any psychiatric condition that would prohibit the understanding or rendering of informed consent\n24. Requirement for continued use of preparations containing St. John's Wort is specifically contraindicated. Other herbal medicinal or natural products that patient is intended to take during the trial must be explored at the beginning and during the course of the trial and discussed with the investigator.\n25. Requirement for continued use of CYP3A inhibitors, inducers or substrates (listed in Appendix 4).\n26. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine as this medicinal product contains lactose.\n27. Any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial.",{"count":111,"type":22},45,[113],"PHASE1","This clinical study is aiming to determine the safest doses and schedule for the combination of two drugs named palbociclib and avelumab.\n\nThe study will also be investigating how effective the combination is for a subgroup of breast cancer patients whose cancer expresses the androgen receptor (AR) but not the oestrogen (hormone) or HER2 receptors. Palbociclib is a drug used in routine care for hormone-receptor (HR) positive and HER2 negative advanced breast cancer, the most common subtype of breast cancer.\n\nIt is possible that the combination of palbociclib and avelumab will be a more effective cancer treatment than each drug separately, but this is unknown and this study is needed to establish the best dosage and schedule of each drug as well as how effective the combination is.",[89,116,117,118,90,119],"Locally Advanced Breast Cancer","Recurrent Breast Cancer","Metastatic Breast Cancer","HER2-positive Breast Cancer",[121,122,123,124],"Palbociclib","Avelumab","Measurable Disease","Inoperable Disease","2026-03-31",{"date":127,"type":37},"2026-04-06",{"date":129,"type":37},"2020-08-11",{"date":131,"type":22},"2026-07-31",{"name":43,"class":44},9,{"id":135,"slug":136,"hasResults":12,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":12,"sex":142,"minAge":19,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":23,"phases":145,"briefSummary":146,"conditions":147,"keywords":149,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},"100565158","dose-de-escalation-in-prostate-radiotherapy-using-an-mr-linac-in-2-fractions-100565158","NCT06638541","Dose dE-eScalaTion IN prostATe radIOtherapy usiNg an MR-Linac in 2 Fractions","Dose dE-eScalaTion IN prostATe radIOtherapy usiNg an MR-Linac in 2 Fractions - a Randomised Trial","DESTINATION 2","Inclusion Criteria:\n\n1. Men aged ≥18 years\n2. Histological confirmation of prostate adenocarcinoma requiring radical radiotherapy\n3. Gleason score 3+3, 3+4 or 4+3 (Grade groups (GG) 1, 2 or 3)\n4. MRI stage T3a or less (as staged by AJCC TNM 2018). MRI must be performed within a year of randomisation\n5. MRI-visible tumour(s) of PIRADS v2 grade 3 or higher and able to be delineated on T2 and diffusion-weighted imaging +\u002F- dynamic contrast-enhanced imaging. Tumour nodule visible on MRI should be considered able to be boosted by treating clinician and \\\u003C2.5cm in maximal dimension\n6. The MRI-defined lesion must be confirmed as malignant on biopsies (Gleason grade must be within the limits expressed in inclusion factor 3)\n7. Patients can be concurrently treated with androgen deprivation therapy (ADT) if this would be standard of care. LHRH analogues, LHRH agonists or Bicalutamide are permitted. ADT is not mandatory where this would usually be omitted.\n8. PSA \\\u003C20 ng\u002Fml prior to starting ADT, if used\n9. WHO Performance status 0-2\n10. Ability of the participant understand and the willingness to sign a written informed consent form.\n11. Willing to consent to contraception during and for 1 year after treatment when applicable.\n12. Ability\u002Fwillingness to comply with the patient reported outcome questionnaires schedule throughout the study.\n\nExclusion Criteria:\n\n1. Contraindications to MRI (e.g. pacemaker, potentially mobile metal implant, claustrophobia)\n2. Severe GU symptoms that would preclude extreme hypofractionation per the discretion of the treating physician.\n3. IPSS Score \\> 19\n4. High grade disease (GG3) occult to MRI-defined lesion. As a guide, any pathology for which you would consider surveillance (eg GG1, low volume GG2) is allowed outside of the MRI-defined area.\n5. Prostate volume \\>90cc\n6. Comorbidities which predispose to significant toxicity (e.g. inflammatory bowel disease) or preclude long term follow up\n7. Hip replacement, or other pelvic metalwork which causes significant artefact on diffusion-weighted imaging\n8. Previous pelvic radiotherapy\n9. Patients needing \\>6 months of ADT due to disease parameters.\n10. Previous invasive malignancy within the last 2 years where this is likely to shorten lifespan the following will remain eligible: basal or squamous carcinomas of the skin, low risk non-muscle invasive bladder cancer (assuming cystoscopic follow up now negative) or small renal masses on surveillance.\n11. Participating in another interventional trial for prostate cancer","MALE",{"count":144,"type":22},54,[25],"DESTINATION 2 is a multi-centre randomised trial treating intermediate risk localised prostate cancer with 2 fraction Stereotactic Body Radiotherapy (SBRT). All radiotherapy will be delivered in two fractions (sessions) on an MR Linac using daily adaptation. Men will either receive uniform dose radiotherapy or de-escalated dose radiotherapy. The primary endpoint is acute GU CTCAE v5 grade 2+ toxicity. It will also look at late toxicity, patient-reported outcome measures and PSA control.",[148],"Prostate Cancer",[150,151,152],"De-escalation","Radiotherapy","MR-Linac","2026-03-19",{"date":155,"type":37},"2026-03-23",{"date":157,"type":37},"2025-01-20",{"date":159,"type":22},"2027-01-01",{"name":43,"class":44},3,{"id":163,"slug":164,"hasResults":12,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":170,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":172,"conditions":173,"keywords":174,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":45},"100599444","feasibility-of-serial-multisite-image-guided-biopsy-to-study-breast-cancer-evolution-100599444","NCT07084571","Feasibility of Serial Multisite Image-guided Biopsy to Study Breast Cancer Evolution","Feasibility of Serial Multisite Image-Guided Biopsy To Study Breast Cancer Evolution","FORTITUDE","Inclusion Criteria:\n\n1. Histologically confirmed locally advanced, inoperable breast cancer or metastatic breast cancer OR radiological evidence of metastatic disease with a high index of suspicion that this is a recurrence of a previously diagnosed breast cancer.\n2. Be aged 18 years and over.\n3. Have given written informed consent to participate.\n\nExclusion Criteria:\n\n1. Metastatic disease limited to bones, without a soft tissue component.\n2. Any bleeding disorders or anticoagulation that cannot be corrected and that would render the risk of biopsy unacceptable.\n3. If the consultant physician involved in the care of the patient assesses and decides the risk of the biopsy procedures is significant, defined as greater than 1% risk of significant complication.\n4. Eastern Cooperative Oncology Group performance status of 3 and higher.\n5. Known chronic infectious disease (Hepatitis B and C, HIV) that may impact patient safety.\n6. Presence of any psychological, familial or sociological condition potentially hampering compliance with the study protocol and follow-up schedule.",{"count":171,"type":22},200,"FORTITUDE is a translational research study that aims to collect serial multi-site needle biopsy samples of tumour tissue and blood from metastatic breast cancer patients. Cancer biopsies are generally performed when cancer is diagnosed and are sometimes repeated when the cancer is suspected to have spread but this is not mandatory. However, studies have shown that cancers change with time and evolve to become resistant to therapy. The purpose of this study is to assess the feasibility of biopsies of multiple cancer sites across different time points during treatment and understand how cancers evolve and change throughout treatment. The findings of this study could pave the way for using cancer biopsies more frequently in the clinic to pick up changes in cancer behaviour that could influence treatment choice. The samples collected from this study will be used for molecular and genetic research to increase our understanding of how metastatic breast cancer changes during treatment and will enable us to develop new cancer treatments and new ways of monitoring response to cancer therapies.",[88,118,89],[175],"Interventional Radiology","2026-03-10",{"date":178,"type":37},"2026-03-12",{"date":180,"type":37},"2026-02-23",{"date":182,"type":22},"2040-04",{"name":43,"class":44},{"id":185,"slug":186,"hasResults":12,"nctId":187,"briefTitle":188,"officialTitle":188,"acronym":189,"eligibilityCriteria":190,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":191,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":193,"conditions":194,"keywords":207,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":45},"100626230","precision-medicine-approaches-for-neoadjuvant-therapy-in-high-risk-sarcoma-patients-100626230","NCT07432932","Precision Medicine Approaches for Neoadjuvant Therapy in High-risk Sarcoma Patients","PANTHR-S","Inclusion Criteria:\n\n* Written informed consent for the prospective cohort\n\n  * Histopathological diagnosis of high-risk soft tissue sarcoma and one of the following subtypes: DDLPS, LMS, SS, vascular sarcomas or MPNST. Other subtypes may be included with PI approval.\n  * High-risk sarcoma definition:\n\n    * Greater than 5cm or Grade 3\n    * Deep anatomic location\n  * Have disease amenable to biopsy\n\n    o Patients who are not amenable to repeat biopsy at baseline can be reviewed with the local site PI for consideration of inclusion to the study\n  * Resectable tumour\n  * Measurable disease by RECIST 1.1\n  * Aged ≥ 18 years\n  * WHO performance status 0-2\n  * For patients receiving NCT, medically fit enough, with adequate organ function, to undergo neoadjuvant chemotherapy\n  * Patients medically fit enough to undergo surgical resection\n  * Capable of giving written informed consent (for prospective cohort) and comply with the study schedule\n  * Patients may also participate in the STRASS 2 trial\n\nExclusion Criteria:\n\n-Prior invasive malignancy in last 5 years, low risk malignancies in the last 5 years may be reviewed by the PI.\n\n* Known additional malignancy that is progressing or requires active treatment\n* Metastatic disease not amenable to curative intent local therapy\n* Any active uncontrolled medical conditions",{"count":192,"type":22},800,"This is a cohort study aimed at developing a stratified medicine approach for personalised neoadjuvant chemotherapy (NCT) in high-risk soft tissue sarcoma (STS) patients with dedifferentiated liposarcoma (DDLPS), leiomyosarcoma (LMS), synovial sarcoma (SS), vascular sarcomas, malignant peripheral nerve sheath tumour (MPNST) or other subtypes. It comprises of both retrospective and prospective tissue collection from patients advancing directly to surgery (control group) and patients receiving NCT and surgery.",[195,196,197,198,199,200,201,202,203,204,205,206],"Sarcoma","Sarcoma, Leiomyo-, Adult","Sarcoma, Synovial, Adult","Soft Tissue Sarcoma (STS)","Soft Tissue Sarcoma Adult","Soft Tissue Sarcoma of the Trunk and Extremities","Soft Tissue Sarcoma of the Limb","Retroperitoneal Sarcoma","Liposarcoma, Dedifferentiated","Liposarcoma","Leiomyosarcoma (LMS)","Angiosarcoma",[208,209,210],"PANTHRS","PANTHRS-S","Sarcoma Accelerator","2026-02-18",{"date":213,"type":37},"2026-02-25",{"date":215,"type":37},"2021-11-19",{"date":217,"type":22},"2028-06-30",{"name":43,"class":44},{"id":220,"slug":221,"hasResults":12,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":225,"eligibilityCriteria":226,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":227,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":229,"conditions":230,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":4},"100507292","irec-bio-and-irec-registry-100507292","NCT05885490","IReC-Bio and IReC Registry","Protocol for The International Centre for Recurrent Head and Neck Cancer (IReC) Tissue Biobank and Data Registry","IReC-Bio","Inclusion Criteria:\n\n* Aged over 18 at time of diagnosis.\n* Confirmed clinical, radiological, and\u002F or histological diagnosis of residual, recurrent, or new primary malignant head and neck cancer arising from the nasopharynx, oropharynx, oral cavity, larynx, hypopharynx, sinonasal cavities, major salivary glands and thyroid gland.\n* Any mucosal, salivary gland, and thyroid histological subtype\n* Ability to give informed consent.\n* Details of clinical follow-up available\n\nFor IReC-BIO only:\n\n* FFPE blocks(s) or fresh frozen tumour tissue available for collection\n* Two or more tumour-containing blocks available from the same specimen\n\nFor QoL Questionnaires only:\n\n• Patients who have received a diagnosis of rHNC no earlier than 6 weeks prior to study entry\n\nExclusion Criteria:\n\n• Recurrent cutaneous (e.g., SCC, melanoma), sarcomatous, and lymphatic or haematological (e.g. lymphoma) malignancies of the head and neck\n\nFor IReC-BIO only:\n\n* FFPE tumour samples contain insufficient tumour sample for analysis.\n* Insufficient clinical details available\n\nFor QoL Questionnaires only:\n\n• Patients who have received a diagnosis of rHNC more than 6 weeks prior to study entry",{"count":228,"type":22},10000000,"IReC is the world's first centre for recurrent head and neck cancers. We have the ambitious aim to create a centre of international excellence and set international standards in the curative treatment of recurrent head and neck cancers.\n\nOne of IReC's key objectives is to develop a national research tissue bank to support laboratory and translational research. The cornerstone of translational research is a well-annotated biobank of cancer samples to explore and validate key research findings.\n\nThe purpose of IReC-Bio is to support research into recurrent head and neck cancers. A central repository for the rarer recurrent cancers will allow the concentration of cases required in order to support translational research programmes. The overall aim is to facilitate research into understanding disease biology, identifying potentially curative treatments, and allow detailed investigations into the relationships between clinical, pathological and molecular characteristics and clinical outcomes.\n\nCombining the IReC Registry and Biobank gives us a comprehensive data and sample set which has never been created before for recurrent head and neck cancer. The aim is to have a national, and in the future international, resource of the study of recurrent head and neck cancer on a molecular and clinical level to support novel ways of treating rHNC.",[231],"Head Cancer Neck","2026-02-09",{"date":234,"type":37},"2026-02-10",{"date":236,"type":22},"2026-04",{"date":238,"type":22},"2050-12",{"name":43,"class":44},{"id":241,"slug":242,"hasResults":12,"nctId":243,"briefTitle":244,"officialTitle":244,"acronym":245,"eligibilityCriteria":246,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":247,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":249,"conditions":250,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":133},"100501412","the-rescue-study-survival-and-functional-outcomes-following-salvage-surgery-for-residual-or-recurrent-squamous-cell-carcinoma-of-the-head-and-neck-100501412","NCT05808920","The RESCUE Study: Survival and Functional Outcomes Following Salvage Surgery for RESidual or reCurrent sqUamous cEll Carcinoma of the Head and Neck","RESCUE","Inclusion Criteria:\n\n1. Aged over 18\n2. Previous H\\&N SCC treated with radiotherapy with or without chemotherapy\n3. Local or regionally recurrent, residual, or new primary SCC of the oropharynx, oral cavity, larynx, and hypopharynx\n4. Ability to give informed consent for biological sample collection (molecular analysis study only)\n\nExclusion Criteria:\n\n1. Nasopharyngeal and cutaneous SCC of the H\\&N\n2. Thyroid, salivary gland, and non-squamous cell H\\&N cancers\n3. Presence of distant metastasis (M1) or surgically inoperable T4b tumours",{"count":248,"type":22},400,"The RESCUE study is a combined retrospective and prospective multicentre cohort study investigating the survival and functional outcomes in patients undergoing salvage surgery for recurrent, residual, and new primary head and neck squamous cell carcinoma (SCC).\n\nAdditionally, the RESCUE study will contain an exploratory molecular analysis of consenting patients to assess the relationship between cancer genomics, previous radiotherapy, and recurrence in head and neck cancer.",[251],"Head and Neck Cancer",{"date":253,"type":37},"2026-02-12",{"date":255,"type":37},"2023-09-08",{"date":257,"type":22},"2029-04-30",{"name":43,"class":44},{"id":260,"slug":261,"hasResults":12,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":265,"eligibilityCriteria":266,"healthyVolunteers":12,"sex":18,"minAge":267,"maxAge":4,"enrollmentInfo":268,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":270,"conditions":271,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":272,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":45},"100414079","exploratory-study-of-clonal-evolution-in-cancer-for-patients-undergoing-transoral-robotic-surgery-for-radiation-exposed-residualrecurrent-tumours-of-the-upper-aerodigestive-tract-100414079","NCT04671940","Exploratory Study of Clonal Evolution in Cancer for Patients Undergoing Transoral Robotic Surgery for Radiation Exposed Residual\u002FreCurrent Tumours of the Upper Aerodigestive Tract","RECUT PLUS: Exploratory Study of Clonal Evolution in Cancer for Patients Undergoing Transoral Robotic Surgery for Radiation Exposed Residual\u002FreCurrent Tumours of the Upper Aerodigestive Tract","RECUT Plus","Inclusion criteria\n\n* Aged over 18\n* Previous H\\&N cancer treated with radiotherapy.\n* Undergoing TORS as part of their management for residual, recurrent or new primary H\\&N cancer.\n\nExclusion criteria\n\n* Where TORS is used in a diagnostic setting only\n* Nasopharyngeal and thyroid head and neck cancers\n* Where no tissue specimens are available from the recurrent\u002Fresidual\u002Fsecondary tumour for the retrospective cohort","19 Years",{"count":269,"type":22},20,"Radical radiotherapy for head and neck squamous cell cancer (HNSCC) can be administered to primary disease with curative intent. Residual disease, recurrence or further tumours may subsequently occur in this irradiated field. It is unknown whether these cancers reflect primary resistance or represent the evolution of resistance on treatment.\n\nUnderstanding this could allow stratification of patients to more effective primary treatments, such as transoral robotic surgery, or help tailor systemic therapies for these cancers in previously irradiated fields.\n\nRECUT+ is an exploratory molecular analysis study to assess the selective impact of radiation therapy on HNSCC.\n\nParticipants will be recruited from the Royal Marsden Hospital (RMH), Chelsea, a tertiary referral H\\&N cancer unit in London, UK, specialising in transoral robotic surgery.\n\nRetrospective participants will be identified from previous Head and neck MDT lists at RMH.\n\nProspective participants will be screened for by the RECUT+ team during the weekly H\\&N MDT meetings at the Royal Marsden Hospital (RMH).\n\nBlood\u002Fsaliva samples will be collected pre operatively (prospective participants) and post operatively (retrospective and prospective participants) for germline and circulating tumour DNA analysis.\n\nBiopsy samples from the original cancer and resected specimens from the post radiotherapy residual\u002Frecurrent\u002Fnew primary disease will undergo molecular analysis to assess for any selective impact of radiotherapy on these further tumours.",[251],{"date":253,"type":37},{"date":274,"type":37},"2020-11-18",{"date":276,"type":22},"2026-10-07",{"name":43,"class":44},{"id":279,"slug":280,"hasResults":12,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":284,"eligibilityCriteria":285,"healthyVolunteers":286,"sex":142,"minAge":19,"maxAge":4,"enrollmentInfo":287,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":288,"conditions":289,"keywords":290,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":4},"100624288","improving-engagement-from-underserved-communities-with-prostate-cancer-genetics-services-100624288","NCT07407686","Improving Engagement From Underserved Communities With Prostate Cancer Genetics Services","Improving the Engagement of Underserved Communities With the Prostate Cancer Genetics Service: Identifying Barriers & Facilitators and Developing Supportive Resources Using a Co-production and Collaborative Approach","INCLUDE PC","Inclusion Criteria:\n\n1. Men and people with prostates age 18 and above\n2. Those who belong to the three underserved groups; Black African and Black Caribbean Ancestry, transgender and non-binary people with a prostate and those with reduced access to healthcare\n3. We allow intersectionality within reason and will narratively describe any instances of these in the writeup of findings\n4. Those who are able to freely consent to inclusion\n5. Individuals with and without a lived experience of prostate cancer\n\nExclusion Criteria:\n\n1. To avoid exhaustion, we will only allow participation in two interview or focus groups per individual for the entirety of the study\n2. Those without capacity to consent to interview (capacity is assumed unless there is good reason to believe otherwise)",true,{"count":21,"type":22},"Earlier work explored barriers and facilitators to accessing prostate cancer screening, particularly in underserved communities, and provided valuable insights to build upon.\n\nThis study will explore perspectives on how genetic risk for prostate cancer is explained and understood through in-depth interviews with members of underserved communities. Findings from this work, alongside earlier results, will be used to co-design clear and accessible digital educational resources in collaboration with community members and relevant charities.\n\nParticipation in cancer screening programmes in the UK varies, with differences linked to socioeconomic status, ethnicity and health literacy. Similar inequalities are seen in access to prostate cancer genetics services, indicating a need for improved engagement.\n\nSuccessful integration of genetics into prostate cancer care requires clear and inclusive information about genetic testing processes, possible outcomes and interpretation of results. Currently, there are limited resources explaining genetic risk for prostate cancer in an accessible way.\n\nCo-production with representatives from underserved communities will ensure that educational materials are understandable, relevant and acceptable to all.",[148],[291,292,293,294,295,296,297,298],"qualitative research methods","co-production","MRC Complex Intervention Developement","Health Literacy and Health Behaviour Theories","Prostate cancer screening in high risk groups","semi-structured interviews and focus groups","reflexive thematic analysis of qualitative data","Evaluation of outputs","2026-02-05",{"date":253,"type":37},{"date":302,"type":22},"2026-02-28",{"date":304,"type":22},"2027-12-31",{"name":43,"class":44},{"id":307,"slug":308,"hasResults":12,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":312,"eligibilityCriteria":313,"healthyVolunteers":12,"sex":142,"minAge":19,"maxAge":4,"enrollmentInfo":314,"targetDuration":4,"studyType":23,"phases":316,"briefSummary":317,"conditions":318,"keywords":320,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":45},"100611688","assessing-a-digital-exercise-intervention-for-health-outcomes-and-engagement-in-regular-exercise-100611688","NCT07243834","Assessing a Digital Exercise Intervention for Health Outcomes and Engagement in Regular Exercise","Assessing a Digital Exercise Intervention for Health Outcomes and Engagement in Regular Exercise (ADHERE): A Randomised Controlled Trial Comparing the Efficacy of a Digital Exercise Intervention With Virtual Supervised Group Exercise Sessions to Standard of Care on Exercise Adherence at Six Months in Patients With Prostate Cancer Undergoing Hormone Therapy.","ADHERE","Inclusion Criteria:\n\n1. Age \\> 18 at randomisation\n2. Men with histological confirmation of prostate adenocarcinoma who are receiving or planned to receive ADT with an LHRHa as part of their PCa treatment\n3. If already started ADT, have received no more than eight weeks ADT at randomisation\n4. Planned for radiotherapy\n5. Assessed by clinical team to be safe to exercise and safe to enter the trial with no absolute contraindications to exercise as defined by clinical guidance\n6. Able to use technological aspects of the intervention including access to MyMarsden and a device for video conferencing\n7. Fluent in English and able to understand instructions\n8. WHO performance status 0-2\n9. Able to give written informed consent\n\nExclusion Criteria:\n\n1. Men planned to receive an androgen receptor-targeted agent (ARTA) or chemotherapy\n2. Absolute contraindication to exercise as defined by ACPICR standards. This includes:\n\n   * New symptoms of angina\n   * New or unstable heart failure\n   * Newly diagnosed diabetes that is not controlled\n   * New or untreated arrhythmias\n   * Resting tachycardia or new bradycardia (not linked to changes in medications)\n   * Symptomatic hypotension\n   * Uncontrolled hypertension (SBP ≥ 180mmHg or DBP≥ 100mmHg)\n3. Unstable spinal bone metastasis or at high risk of a fracture\n4. Musculoskeletal issue inhibiting exercise",{"count":315,"type":22},160,[25],"Patients diagnosed with prostate cancer and receiving hormone therapy in conjunction with radiotherapy are likely to suffer from adverse effects caused by ADT treatment either short term or long term. The most common side effects include changes in body composition leading to increased visceral fat and reduced lean muscle mass, increased risk of cardiovascular events and fatigue, which overall lower quality of life.\n\nThere is strong evidence to support exercise interventions in minimising, and in some cases reversing many ADT -related toxicities, but exercise adherence remains a challenge for people living with prostate cancer, particularly due to logistical barriers to attendance such as cost and travel time, as well as insufficient motivation.\n\nThe aim of this single centre, phase III randomised controlled trial is to assess the efficacy of a new digital exercise programme with virtual supervised group exercise sessions in improving adherence to exercise guidelines.\n\nThe trial aims to recruit 160 participants with prostate cancer undergoing ADT, who will be allocated either the standard of care group or standard of care plus participation in the digital exercise intervention on a 1:1 ratio.\n\nAdherence to physical activity will be measured using a wearable accelerometer, an exercise diary, self-reported questionnaires and clinic based assessments at 3 months, 6 months and 12 months post radiotherapy treatment. Recruitment will take place at the Royal Marsden NHS Foundation Trust, Chelsea.",[148,319],"Prostate Cancer (Diagnosis)",[321,322,323],"Exercise intervention","physical activity","adherence","2026-01-29",{"date":326,"type":37},"2026-01-30",{"date":328,"type":37},"2025-12-16",{"date":330,"type":22},"2030-04-28",{"name":43,"class":44},{"id":333,"slug":334,"hasResults":12,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":338,"eligibilityCriteria":339,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":340,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":341,"conditions":342,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":45},"100464697","understanding-immune-related-toxicities-by-multifacet-profiling-100464697","NCT05331066","Understanding immunE-related toXicities by multifACeT Profiling","EXACT - Understanding immunE-related toXicities by multifACeT Profiling","EXACT","Inclusion Criteria:\n\n* Written informed consent\n* Age 18 years or older\n* Confirmed diagnosis of any form of solid malignancy with a clinical indication and appropriate treatment plan to commence immune checkpoint inhibitor therapy\n\nExclusion Criteria:\n\n* Medical or psychological condition that would preclude informed consent\n* Planned participation in a drug trial receiving investigational agents\n* Subjects who have previously commenced immune checkpoint inhibitor therapy prior to study entry.\n* Subjects unable to comply with the study or sample schedule.",{"count":171,"type":22},"A prospective observational cohort study of patients undergoing CPI therapy in which translational research is the fundamental aspect of the study.",[343],"Oncology","2025-09-26",{"date":346,"type":37},"2025-10-01",{"date":348,"type":37},"2022-04-06",{"date":350,"type":22},"2028-04-06",{"name":43,"class":44},{"id":353,"slug":354,"hasResults":12,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":358,"eligibilityCriteria":359,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":360,"targetDuration":4,"studyType":23,"phases":362,"briefSummary":364,"conditions":365,"keywords":369,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":381,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":387,"locationsCount":133},"100535300","phase-2-zimberelimab-anti-pd1---domvanalimab-in-resectable-mmrd-gastric-cancer-100535300","NCT06250036","Zimberelimab Anti-PD1 +\u002F- Domvanalimab in Resectable Mmrd Gastric Cancer","A Randomised Phase II Study of Zimberelimab Anti-PD1 immunOtherapy +\u002F- Domvanalimab Anti-TIGIT Immunotherapy in Resectable Mismatch Repair Deficient Gastric and Gastro-oesophageal Junctional AdenoCarcinoma","ZODIAC","Inclusion criteria\n\n* Age: ≥18 years\n* Histologically confirmed gastric or gastro-oesophageal junctional (GOJ) adenocarcinoma (inclusive of Siewert-stein classification type I-III (62))\n* MMRd\u002FMSI-H. There are three different methods validated for detection (63) :\n\n  * Immunohistochemistry (IHC) staining for expression of MMR proteins (MLH1, MSH2, PMS2 and MSH6), MMRd defined as loss of function or one or more of these proteins.\n  * Polymerase chain reaction (PCR) amplification of microsatellite sequences\n  * Next-generation sequencing (NGS) for detection of MSI\n  * Stage II-IIIB: TNM T2-T4, N0-N3, M0\n* Absence of distant metastatic disease on CT scan + PET CT + staging laparoscopy prior to study entry.\n* MDT determined suitable for surgery and MDT believes an R0 resection is achievable after neo-adjuvant therapy (resectable disease)\n* No prior anti-cancer therapy for gastric \u002F GOJ adenocarcinoma\n* ECOG performance status 0-2\n\nLaboratory parameters\n\n• Adequate haematologic and end-organ function defined by the following laboratory test results: Haematology: Absolute neutrophil count \\> 1.5 x 109\u002FL Platelets \\> 100 x 109\u002FL Haemoglobin \\> 90 x 109\u002FL (can be post-transfusion) Biochemistry: Serum Creatinine Clearance \\>50ml\u002Fmin (calculated using Cockcroft-Gault formula Appendix X)\n\nLiver function: Bilirubin within normal limits ALT\u002FAST ≤2.5x ULN\n\nCoagulation profile (for patients not receiving therapeutic anticoagulation):\n\nInternational Normalised Ratio (INR) \\\u003C 1.5 Activated Prothrombin Time (APTT) \\\u003C 1.5xULN\n\n* Before patient registration\u002Frandomisation, written informed consent must be given according to ICH\u002FGCP, and national\u002Flocal regulations\n* Patient is fit to undergo all protocol investigations and receive all protocol treatment based on the assessment in the surgical \u002F oncology clinic\n* Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrolment\n* Willingness and ability to comply with the protocol for the duration of the study including scheduled visits, examinations, investigations and treatment plans\n\nExclusion criteria\n\nPatients are not eligible for the trial if any of the exclusion criteria below are met:\n\n* Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥ 3CTCAE v5.0, any history of anaphylaxis\n* Any prior treatment with cancer immunotherapy including anti-PD-1, anti-TIGIT, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways\n* Treatment with systemic immunosuppressive medications, including but not limited to: corticosteroids (dose of \\> 10mg\u002Fday prednisone equivalent) cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumour necrosis factor \\[TNF\\] agents) within 2 weeks prior to Cycle 1 Day 1\n* Prior malignancy active within the previous 2 years except for:\n* locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix\n* localised prostate cancer\n* breast cancer diagnosed \\>2 years ago, now on adjuvant endocrine therapy (no known active disease)\n* Patients recommended to have radiotherapy as part of routine management for their gastric\u002FGOJ AC are ineligible\n\nQTc ≥480 msec using Fredericia QT correction formula\n\n* Metastatic disease on imaging or staging laparoscopy - visualisation of peritoneal disease on staging laparoscopy is an exclusionPrior organ transplantation, including allogeneic stem-cell transplantation\n* Any active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs) or is expected to deteriorate when receiving immunotherapy, with the following exceptions:\n* Patients with autoimmune hypothyroidism on a stable dose of thyroid replacement hormone are eligible\n* Patients only receiving hormone replacement therapy e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy (doses ≤10mg - or equivalent - of prednisolone per day) for adrenal or pituitary insufficiency) are eligible\n* Patients with eczema, psoriasis, lichen simplex chronicus or vitiligo with dermatologic manifestations only not requiring immunosuppressive treatment are eligible, providing they meet the following conditions\n* Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\n* Rash mush cover less than 10% of body surface area\n* Disease is well controlled at baseline and only requiring low-potency topical steroids\n* No acute exacerbations of underlying condition within the last 12 months\n* Patients with controlled type 1 diabetes mellitus on a stable dose of insulin regimen are eligible\n* Patients requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement\n* Administration of steroids through a route known to result in minimal systemic exposure (topical, intranasal intra-ocular, or inhalation) are acceptable. Steroids as pre-medication for hypersensitivity reactions e.g., CT contrast are also acceptable\n* History of inflammatory bowel disease with the following exception:\n* Patients with a history of ulcerative colitis who have had a colectomy are eligible\n* Patients with a history of interstitial lung disease or radiological evidence of pulmonary fibrosis\n* Cerebrovascular disease (including transient ischaemic attacks (TIA) and strokes) within the 6 months prior to Cycle 1 Day 1\n* Cardiovascular diseases as follows:\n* Myocardial infarction within the previous year\n* Serious cardiac arrhythmia requiring medication (for example, ventricular tachycardia, supraventricular tachycardia or atrial fibrillation with a resting heart rate \\> 110bpm)\n* Unstable angina\n* Congestive cardiac failure (New York Heart Association Classification Class III or IV), EF \\\u003C50%\n* Active infection requiring systemic therapy, non-healing wound, ulcer or bone fracture requiring therapy\n* Major surgery, major trauma within 28 days prior to registration (not including staging laparoscopy)\n* Current signs or symptoms of any other severe progressive or uncontrolled hepatic, haematologic, gastrointestinal, endocrine, respiratory or cardiac disease other than directly related to gastric\u002FGOJ adenocarcinoma, which in the opinion of the investigator, might impair the subject's tolerance of trial treatment or procedures\n* Other severe acute or chronic medical conditions or psychiatric conditions including recent (within the past year) active suicidal ideation or behaviour\n* Active\u002F uncontrolled Hepatitis A, B or C infection, for hepatitis B known positive HBV surface antigen (HBsAg) result, patients with past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are only eligible if polymerase chain reaction is negative for HCV RNA.\n* Uncontrolled human immunodeficiency virus (HIV) infection\n* If known HIV diagnosis and well controlled on anti-retrovirals (CD4 count ≥350cells\u002Ful and undetectable viral load) patient is eligible, ensure HIV team involvement for management and monitoring whilst on treatment\n* Use of live attenuated vaccine within 28 days of initiation of study therapy, or anticipation that a live attenuated vaccine will be required during the study\n* Pregnancy must be excluded with a negative serum pregnancy test, within 3 days before initiation of therapy, if the risk of conception exists. Sexually active female patients must be surgically sterile or be postmenopausal or must agree to use highly effective contraception. Sexually active male patients must be surgically sterile or must agree to use highly effective contraception, i.e. methods with a failure rate of \\\u003C1% per year (see section 5.4 for full definition and examples of highly effective contraception)\n* Lactation-breast-feeding is contraindicated and must be discontinued for the duration of the study period and for the required duration of the contraception use after the last dose of the study drug.\n* Any patient specific factors which are likely to interfere with compliance of trial specific procedures or treatment, including any medical or psychiatric conditions that in the investigator's or sponsor's opinion poses an undue risk to the participant's participation in the study or may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.",{"count":361,"type":22},50,[363],"PHASE2","A phase II study of peri-operative anti-PD1 (Zimberelimab) +\u002F- anti-TIGIT (Domvanalimab) in resectable mismatch repair deficient (MMRd)\u002F high micro-satellite instability (MSI-H) gastric\u002Fgastro-oesophageal junctional (GOJ) adenocarcinoma (AC)",[366,367,368],"Locally Advanced Gastric Adenocarcinoma","MSI-H\u002FdMMR Gastric Cancer","MSI-H\u002FdMMR Gastroesophageal-junction Cancer",[370,371,372,373,374,375,376,377,378,379,358],"dMMR","MMRd","MSI-H","gastric adenocarcinoma","GEJ adenocarcinoma","Gastroesophageal-junction adenocarcinoma","Peri-operative","MMRd\u002FMSI-H operable gastric\u002FGEJ adenocarcinoma","domvanalimab","zimberelimab","2025-08-19",{"date":382,"type":37},"2025-08-21",{"date":384,"type":37},"2025-02-20",{"date":386,"type":22},"2031-09-01",{"name":43,"class":44},{"id":389,"slug":390,"hasResults":12,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":394,"eligibilityCriteria":395,"healthyVolunteers":12,"sex":54,"minAge":19,"maxAge":4,"enrollmentInfo":396,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":398,"conditions":399,"keywords":400,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":405,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":411,"locationsCount":45},"100603456","mibreast-making-in-immediate-breast-reconstruction-and-the-measurement-of-the-effects-of-radiotherapy-100603456","NCT07136753","MIBREAST Making in Immediate Breast REconstruction And the Measurement of the EffectS of RadioTherapy","The IMpact of 3D Surface Imaging and Simulation on Shared Decision Making in Immediate Breast REconstruction And the Measurement of the EffectS of RadioTherapy","MIBREAST","Inclusion Criteria:\n\n* Female\n* Aged \\> 18\n* Undergoing immediate breast reconstruction (autologous or implant based) follow mastectomy for breast cancer or as a risk-reducing strategy\n* Available to attend 3D-SI appointments at specified intervals\n\nExclusion Criteria:\n\n* Lack of capacity\n* Language barrier that prevents patients from understanding the English questionnaires\n* Visual impairment\n* Unable to answer study questionnaires\n* Disability that may prevent appropriate positioning during the imaging process\n* Unable to attend for photography\n* Requiring delayed reconstruction or no longer considering a reconstruction",{"count":397,"type":22},300,"Patients who require a removal of a breast (mastectomy) for breast cancer or future risk reduction often have immediate breast reconstruction (IBR). This can be performed using either an implant or the patient's own body fat to recreate the breast shape.\n\nPatients can find it difficult to imagine their own post-surgery appearance. Using 3D surface imaging (3D-SI) can change a patient's pictures to show them how they might look after surgery, known as a simulation. Some patients may find 3D-SI and simulation gives them confidence in their expectations and others may not feel it helps much.\n\nThis study will investigate the following 3 questions:\n\n1. Whether 3D-SI and simulation can improve patient confidence about their likely post-surgery appearance\n2. Whether 3D-SI measurement of breast shape helps in surgical planning and reduces the need for later adjustment surgery to improve symmetry, especially in patients having a mastectomy on one side only\n3. How much radiotherapy changes breast reconstructions over time using 3D- SI to objectively measure this. For this study the follow up for some women who do and some who do not have radiotherapy after breast reconstruction.\n\n3D surface imaging may improve surgeon understanding of breast shape, prior to surgery. In cases where there is a high risk of breast cancer recurrence patients are offered radiotherapy to the breast, either before or after surgery. Radiotherapy has a negative impact on the reconstructed breast, and may cause it to shrink and change position but the effect of radiotherapy has never been accurately quantified. This study will be investigating the following:\n\n1. Whether 3D-SI measurement of breast shape helps in surgical planning and reduces the need for later adjustment surgery to improve symmetry, especially in patients having a mastectomy on one side only\n2. How much radiotherapy changes breast reconstructions over time using 3D- SI to objectively measure this. For this study the follow up some women who do and some who do not have radiotherapy after breast reconstruction.",[88],[401,402,403],"Decision making","Reconstruction","Risk reducing surgery","2025-08-14",{"date":406,"type":37},"2025-08-22",{"date":408,"type":37},"2024-09-12",{"date":410,"type":22},"2030-09",{"name":43,"class":44},{"id":413,"slug":414,"hasResults":12,"nctId":415,"briefTitle":416,"officialTitle":416,"acronym":417,"eligibilityCriteria":418,"healthyVolunteers":12,"sex":142,"minAge":19,"maxAge":4,"enrollmentInfo":419,"targetDuration":4,"studyType":23,"phases":421,"briefSummary":422,"conditions":423,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":426,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":45},"100559190","phase-2-preoperative-planning-with-psma-pet-in-melanoma-surgery-trial-100559190","NCT06560905","Preoperative Planning With PSMA-PET in Melanoma Surgery Trial","PPPIMS","Inclusion Criteria:\n\n* Males ≥18 years of age\n* Biopsy proven first and recurrent metastatic melanoma with palpable nodal disease who have undergone a staging FDG PET-CT scan as part of routine clinical care and are scheduled for surgery for resection of the primary site\n\nExclusion Criteria:\n\n* Patients unable to give voluntary written informed consent to participate in this study\n* Patients not willing to complete all the study assessments\n* Patients who are females\n* Patients who are taking androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists.\n* Patients who have or have previously been diagnosed with prostate cancer\n* Patients who have had Lu-177 PSMA therapy or barium studies within a period of 10 days prior to undergoing PSMA PET-CT scanning\n* Patients not fluent in English",{"count":420,"type":22},16,[363],"This is a non-randomised, single-centre Phase 2 study, investigating whether the diagnostic biomarker, prostate-specific membrane antigen (PSMA), can detect melanoma metastases using PSMA PET\u002F CT.",[424],"Malignant Melanoma","2025-06-26",{"date":427,"type":37},"2025-07-01",{"date":429,"type":37},"2025-03-11",{"date":431,"type":22},"2025-12-31",{"name":43,"class":44},{"id":434,"slug":435,"hasResults":12,"nctId":436,"briefTitle":437,"officialTitle":437,"acronym":438,"eligibilityCriteria":439,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":440,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":441,"conditions":442,"keywords":448,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":453,"startDateStruct":455,"completionDateStruct":457,"leadSponsor":459,"locationsCount":45},"100593615","feasibility-study-of-tissue-and-blood-collection-in-oncogene-addicted-and-neoadjuvantly-treated-non-small-cell-lung-cancer-100593615","NCT07008742","Feasibility Study of Tissue and Blood Collection in Oncogene-addicted and Neoadjuvantly Treated Non Small Cell Lung Cancer","FeStival","Inclusion Criteria (Cohort 1):\n\n1. Age \\>\u002F= 18.\n2. Histologically confirmed locally advanced or metastatic NSCLC\n3. ECOG performance score 0-2\n4. Tier 1 ASCO\u002FAMP NSCLC oncogenic variant identified through routine clinical methods, e.g. EGFR, ALK, ROS1, RET, MET, KRAS, BRAF, HER2, NTRK\n5. Planned to commence targeted therapy (any line of therapy)\n\n   o This includes bispecific antibodies (e.g. amivantamab), and antibody-drug conjugates (e.g. trastuzumab-deruxtecan)\n6. Regular follow-up and monitoring for cancer recurrence per standard of care planned at the enrolling site\n7. Provided written informed consent to participate in the study\n\nInclusion Criteria (Cohort 2)\n\n1. Age \\>\u002F= 18.\n2. Histologically confirmed stage II\u002FIII operable NSCLC\n3. Planned to undergo neoadjuvant CPI-based therapy\n4. Provided written informed consent to participate in the study\n\nExclusion Criteria:\n\n• Patient too medically unstable to commit to sampling required for the study",{"count":21,"type":22},"This study aims to determine if it is feasible to collect samples of blood and viable lung cancer tissue in patients with either:\n\n* Stage IV mutation-driven NSCLC\n* Stage II-III NSCLC undergoing neoadjuvant immunotherapy prior to surgery\n\nViable tissue has been defined by the collaborating pathology department as the presence of viable tumour cells, in accordance with recommendations from the International Association or the Study of Lung Cancer.\n\nIn patients with stage IV NSCLC, obtaining adequate samples of viable tissue for advanced testing can be challenging, as sites of cancer that are accessible by biopsy are often small, and contain few viable cancer cells. If obtained, however, viable blood and tissue specimens can be utilised for genetic and other analyses aimed at identifying cancer markers that may offer prognostic information, or that may potentially lead to development of therapies that target these markers in the future.\n\nIn patients with stage II-III NSCLC, the use of immunotherapy prior to surgery has been shown to affect the proportion of viable tumour tissue at the time of surgery, although this needs to be further studied. There is a need to better understand the genetic basis of these tumours to improve response rates to immunotherapy prior to surgery.\n\nThe study will be open for four years in total. The first three years will consist of recruitment and participant follow up, and the fourth year will consist of follow up only. Data analysis will occur in the fifth year when the study is closed.",[443,444,28,445,446,447],"Oncogene-addicted Non Small Cell Lung Cancer","Early-stage Operable Non Small Cell Lung Cancer","Metastatic Non Small Cell Lung Cancer","Locally Advanced NSCLC - Non-Small Cell Lung Cancer","Stage 2\u002F3 Operable Non Small Cell Lung Cancer",[449,450,451],"tissue","blood","feasibility study","2025-06-13",{"date":454,"type":37},"2025-06-15",{"date":456,"type":37},"2025-06-04",{"date":458,"type":22},"2029-06-01",{"name":43,"class":44},{"id":461,"slug":462,"hasResults":12,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":466,"eligibilityCriteria":467,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":468,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":470,"conditions":471,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":473,"lastUpdatePostDateStruct":474,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":45},"100502928","climb-cns-lymphoma-imaging-and-molecular-biomarkers-study-100502928","NCT05828628","CLIMB: CNS Lymphoma Imaging and Molecular Biomarkers Study","A Prospective Imaging and Translational Tissue Study in CNS Lymphoma to Enable Further Disease Characterisation and the Development of Potential Predictive and Prognostic Biomarkers","CLIMB","Inclusion Criteria:\n\n* Subjects capable of giving informed consent, or if appropriate, if subject's capacity is deemed limited due to CNS involvement, a consultee can provide consent on their behalf. Some patients with PCNSL may be incapable of providing their own consent due to the neurological effects of their disease. In these cases the patient will be classed as an incapacitated adult and a legal representative will be sought in accordance with English or Scottish law as applicable (see 7.2.1)\n* A radiological or histological diagnosis of primary CNS lymphoma.\n* Have not received prior CNS directed therapy. Prior use of steroids is permitted.\n* Participants aged ≥18 years old.\n\nExclusion Criteria:\n\n\\- Involvement of lymphoma outside of the CNS",{"count":469,"type":22},36,"A prospective imaging and translational tissue study in CNS lymphoma to enable further disease characterisation and the development of potential predictive and prognostic biomarkers.",[472],"CNS Lymphoma","2025-06-05",{"date":475,"type":37},"2025-06-11",{"date":477,"type":37},"2023-09-18",{"date":479,"type":22},"2031-09",{"name":43,"class":44},{"id":482,"slug":483,"hasResults":12,"nctId":484,"briefTitle":485,"officialTitle":486,"acronym":487,"eligibilityCriteria":488,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":489,"targetDuration":4,"studyType":23,"phases":491,"briefSummary":492,"conditions":493,"keywords":496,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":501,"lastUpdatePostDateStruct":502,"startDateStruct":504,"completionDateStruct":506,"leadSponsor":508,"locationsCount":45},"100592610","partial-volume-high-dose-irradiation-in-renal-cell-carcinoma-for-intra-tumoural-control-alongside-current-management-100592610","NCT06995664","Partial Volume High-Dose Irradiation in Renal Cell Carcinoma for Intra-TUmoural Control ALongside Current Management","Partial Volume High-Dose Irradiation in Renal Cell Carcinoma for Intra-TUmoural Control ALongside Current Management - a Randomised Feasibility Study","VIRTUAL","Inclusion Criteria:\n\n* Histologically confirmed renal cell carcinoma (RCC) (histological confirmation of metastasis not required) or clinically consistent with RCC as per multidisciplinary team (MDT) diagnosis.\n* Not suitable for surgical resection, metastasectomy or ablative therapy due to tumour or patient factors\n* All extracranial sites which clinically require radiotherapy (as per clinician discretion)\n* Age ≥18 years\n* Karnofsky Performance Status (KPS) ≥50\n* Adequate baseline organ function applicable to site-of irradiation\n* Haemaglobin ≥90g\u002Fdl\n* Platelets ≥50\n* Bilirubin \\\u003C3x ULN\n* INR \\\u003C1.4 or correctable with vitamin K\n* AST or ALT \\\u003C5x normal range\n* Creatinine \\\u003C200umol\u002FL (or established on dialysis). Note patients on dialysis are unable to have dynamic contrast enhanced MRI.\n* The use of concurrent systemic therapy is acceptable\n* Ability of the research subject to understand and the willingness to sign a written informed consent document\n* Able to undergo all mandated staging and follow-up investigations\n* Negative pregnancy test (for women of childbearing potential)\n\nExclusion Criteria:\n\n* Expected prognosis \\\u003C6 months\n* Uncontrolled intracranial metastases\n* Previous radiotherapy, such that the delivery of further radiotherapy is not feasible\n* Unable to have necessary radiotherapy planning, radiotherapy related investigations\u002Ffiducials (if required)\n* Co-morbidities or any psychological, familial, sociological or geographical condition which may preclude ability to undergo\u002Fattend investigations, treatment or follow-up\n* Other active primary cancer\n* Pregnant or lactating\n* Requiring ongoing treatment with a concomitant medication, which is contraindicated alongside radiotherapy (e.g. methotrexate)",{"count":490,"type":22},24,[25],"Prospective, randomised, feasibility study of patients with localised or metastatic renal cell carcinoma (RCC) comparing standard palliative dose radiotherapy to a high-dose hypofractionated regime.\n\nPrimary aim\n\n• To demonstrate feasibility of a randomised study comparing high-dose hypofractionated radiotherapy versus standard palliative dose radiotherapy in localised or metastatic renal cell carcinoma The aim is to recruit a minimum of 24 patients; 12 to the control arm and 12 to the high-dose regime.\n\n2 treatment arms, no placebo:\n\n* Control arm - standard palliative-dose radiotherapy, 30Gy in 10 fractions in 3Gy per fraction over 2 weeks\n* High-dose arm - high-dose radiotherapy, 30Gy in 5 fractions in 6Gy per fraction on alternate days\u002F2-3 fractions a week over 2 weeks",[494,495],"Renal Cell Carcinoma","Renal Cell Carcinoma Metastatic",[497,498,499,500],"standard palliative dose radiotherapy","high-dose hypofractionated radiotherapy","radiotherapy","unblinded","2025-05-21",{"date":503,"type":37},"2025-05-29",{"date":505,"type":37},"2023-03-27",{"date":507,"type":22},"2026-05",{"name":43,"class":44},{"id":510,"slug":511,"hasResults":12,"nctId":512,"briefTitle":513,"officialTitle":513,"acronym":514,"eligibilityCriteria":515,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":516,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":517,"conditions":518,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":520,"startDateStruct":522,"completionDateStruct":524,"leadSponsor":526,"locationsCount":45},"100349611","value-of-analysing-under-utilised-leftover-tissue-vault-100349611","NCT03832062","Value of Analysing Under-utilised Leftover Tissue (VauLT)","VauLT","Inclusion Criteria:\n\n1. Leftover formalin-fixed tissue (ie that would be otherwise discarded by histopathology) from cancer surgery.\n2. Tissues for Research consent has been provided.\n3. Patient age \\>18yo.\n4. Minimum of 1 gram of residual tumour remaining in leftover surgical tissue\n5. Minimum of 1 gram of normal tissue present.\n\nExclusion Criteria:\n\n1. Advanced Practitioner in histological dissection deems tumour sample to be inadequate.\n2. Leftover surgical tumour tissue greater than 20kg.",{"count":192,"type":22},"Intratumour heterogeneity is well recognized in multiple cancer types and ultimately leads to therapeutic resistance. It also limits the ability of small samples to represent the whole tumour, having implications for diagnosis, molecular analysis and understanding of the tumour immune microenvironment. By blending- 'homogenizing'- leftover tumour tissue in excess of that required for diagnosistic purposes, one may create a more representative sample for analysis.",[343],"2025-05-14",{"date":521,"type":37},"2025-05-18",{"date":523,"type":37},"2018-09-10",{"date":525,"type":22},"2028-12-31",{"name":43,"class":44},{"id":528,"slug":529,"hasResults":12,"nctId":530,"briefTitle":531,"officialTitle":532,"acronym":4,"eligibilityCriteria":533,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":534,"targetDuration":536,"studyType":85,"phases":4,"briefSummary":537,"conditions":538,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":541,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":547,"locationsCount":548},"100506614","rdc-biomarker-study-100506614","NCT05876676","RDC Biomarker Study","Rapid Diagnostic Centre Biomarker Study","Inclusion Criteria:\n\n* Patients referred to undergo investigation for suspected cancer within a non-tumour site specific RDC\n* Age \\> 18 years\n\nExclusion Criteria:\n\n* Previously treated (treatment completed within 5 years preceding recruitment)\n* Current confirmed diagnosis of active malignancy\n* Unable to or unwilling to give informed consent",{"count":535,"type":22},1000,"12 Months","Rapid Diagnostic Centres\n\nRapid Diagnostic Centres (RDC) were built to diagnose patients who have common symptoms that occur in cancer, but it is unclear if they have cancer or not. These symptoms include:\n\n* Weight loss\n* Fatigue\n* Cough\n* GP suspicion\n\nOnly 1 in every 10 patients (10%) referred to an RDC will have cancer. Some of the patients with cancer may have been more likely to develop cancer due to inherited or environmental factors. Some of the patients who don't have cancer may also be at higher risk of developing cancer at another time due to inherited or environmental factors.\n\nAims\n\nThe goal of this observational study is to develop a new blood or non-blood test that could help doctors at RDC:\n\n* detect which patients have cancer through a simple and quick blood or non-blood test\n* detect patients who are at higher risk of having cancer. This is so they can be monitored or guided towards cancer-screening programmes\n\nMain End Points\n\n* The study will be considered a success if a test or mixture of tests is developed that can correctly sort patients into cancer or non-cancer groups.\n* Also, the study will be considered a success if a test or mixture of tests can show what type of cancer a patient has if they have cancer.\n\nTests\n\nTo create this new blood or non-blood test the study will take the following samples from 1000 patients in the RDC Biomarker Study:\n\n* Breath samples (around 300 patients) - People with cancer have different levels of chemicals in their breath than people without cancer. The study hopes to develop a breath test which could show if a patient has cancer or not.\n* Blood samples ( around 1000 patients) - The study hopes to develop a blood test that could show if a patient has cancer or not\n* Saliva samples (around 1000 patients) - For many cancers, while there is a genetic component there is no one single gene that causes cancer. Instead, it can be a combination of hundreds of genes that causes the risk of cancer in a person to go up. The study hopes to develop a test which could provide a risk score. This risk score is called a 'polygenic risk score' which would tell doctors how likely a patient is to get cancer.\n\nMethod Patients who meet the criteria to be able to join the study will be asked either via telephone before their appointment, or face-to-face at an appointment at the RDC if they would like to join the study. If they agree to join the study they will read a patient information sheet and sign a consent form to say they understand what the study requires.\n\nThe patient will then provide blood and saliva samples and in some cases breath samples at their first appointment. They will be then asked to provide further samples (up to three) at their follow-up appointments. Please see below for samples that will be asked for at each appointment:\n\nFirst appointment: Breath (not all sites), Blood, Saliva (not all sites), Survey Follow-up 1: Any samples that could not be taken at the first appointment Follow-up 2: Any samples that could not be taken at the first appointment\n\nThe patient will be provided with a Study ID to identify their samples. This is a unique code to identify each person on the study. Only the site that recruited the participant will have access to the personal information that matches which patients is known by which Study ID. All organisations external to the site will only know the patient as the Study ID. An example of the study ID could be RDCRMH001.\n\nA trained clinical member of the research team at the RDC will take the sample and ship it to the relevant laboratory for testing.\n\nAs well as blood and non-blood tests, information about the patients will be collected This includes routinely collected clinical data alongside investigation results. No patient identifiable information such as:\n\n* Name\n* Address\n* Date of birth\n* Contact details\n\nwill be collected, and a Study ID will be used to identify the data.\n\nA patient questionnaire will be sent out to patients to complete for each appointment asking questions about the patient's health. The RDC doctors treating the patient will see survey answers before the appointment to allow them to act about anything worrying.\n\nFor a small group of patients anonymised copies of thier scans from their medical records will also be taken.\n\nStudy Duration Once the study has recruited 1000 patients, it will close to recruitment. These patients will then be followed up for 12 months following the date they joined the study.",[539],"Cancer","2025-04-14",{"date":542,"type":37},"2025-04-17",{"date":544,"type":37},"2023-07-10",{"date":546,"type":22},"2032-07-10",{"name":43,"class":44},10,{"id":550,"slug":551,"hasResults":12,"nctId":552,"briefTitle":553,"officialTitle":554,"acronym":4,"eligibilityCriteria":555,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":556,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":558,"conditions":559,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":561,"lastUpdatePostDateStruct":562,"startDateStruct":564,"completionDateStruct":566,"leadSponsor":568,"locationsCount":45},"100581851","the-emirates-study-100581851","NCT06855680","The EMIRATES Study","The EMIRATES Study - Development and Evaluation of Thyroid Cancer Patient Decision Aid (PDA-TC) - Pilot Study","Inclusion Criteria:\n\n* Aged over 18\n* Both genders\n* Patients who are diagnosed of low-risk well-differentiated thyroid carcinoma (papillary thyroid carcinoma or follicular carcinoma) with size of 1-4cm. This is either:\n\n  1. Diagnosed pre-operatively by fine-needle aspiration cytology (FNAC) with Thy5 grade \\[see appendix for the Thy classification\\] or\n  2. Confirmed following diagnostic hemithyroidectomy\n* Able to communicate in spoken and written English\n\nExclusion Criteria:\n\n* Patients who are diagnosed with thyroid cancer with adverse features (i.e. poor differentiated cytology or tall cell, columnar cell, Hurthle cell, and solid variant cytology)\n* Patients who are diagnosed with thyroid cancer which is multifocal, bilateral, with extrathyroidal extension, with perineural invasion or angioinvasion.\n* Patients who are diagnosed with thyroid cancer with clinically or radiologically involved nodes or distant metastases\n* Patients who are diagnosed with thyroid cancer which is of a familial disease\n* Patient who is either Pregnant or breast-feeding\n* Patient with hyper- or hypothyroidism who is a candidate for surgery\n* Patient who is concurrently diagnosed with any medullary, anaplastic, lymphoma, or parathyroid disease\n* Patients who had previous thyroidectomy for reasons other than diagnostic hemithyroidectomy for their recent cancer diagnosis.\n* Patients who are cognitively impaired or have a mental health condition and are therefore unable to give consent\n* Patient who is not able to read write and speak English",{"count":557,"type":22},15,"This pilot study will take place in thyroid outpatient clinics. It will have two study arms running in consecutive order: first, a Control arm where standard care will take place without PDA-TC, then a Patient Decision Aid (PDA) arm where the PDA-TC is implemented into the clinical practice. Within each arm, eligible patients will attend two thyroid cancer outpatient clinical consultations during which the patient will make a shared decision with their clinicians regarding surgical treatment between hemithyroidectomy and total thyroidectomy. In the PDA arm, the PDA TC pamphlet will be introduced to study participants after the initial clinical consultation. The participants will be encouraged to read and digest information related to the disease and treatment options on PDA-TC before returning for their second consultation where a treatment decision will be made together with their clinicians. Participants will be asked to complete the Decisional Conflict Scale questionnaire after each consultation in both study arms. The patient will also complete a Satisfaction with Decision Scale questionnaire and a Preparation for Decision Making Scale questionnaire after the second consultation in both arms.",[560],"Differentiated Thyroid Cancer (DTC)","2025-03-18",{"date":563,"type":37},"2025-03-21",{"date":565,"type":37},"2024-06-19",{"date":567,"type":22},"2025-10-14",{"name":43,"class":44},{"id":570,"slug":571,"hasResults":12,"nctId":572,"briefTitle":573,"officialTitle":574,"acronym":575,"eligibilityCriteria":576,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":577,"targetDuration":4,"studyType":23,"phases":579,"briefSummary":580,"conditions":581,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":583,"lastUpdatePostDateStruct":584,"startDateStruct":586,"completionDateStruct":588,"leadSponsor":590,"locationsCount":45},"100581774","dose-escalated-radiotherapy-for-rectal-cancers-using-mr-guided-radiotherapy-100581774","NCT06854679","Dose Escalated Radiotherapy for Rectal Cancers Using MR-guided Radiotherapy","A Feasibility Study in Dose Escalated Treatment in Rectal Cancer on Mr-Linac Using Mr GuidED Adaptive Radiotherapy","ANDROMEDA","Inclusion Criteria:\n\n* All patients aged ≥18 years\n* Histological confirmation of locally advanced rectal adenocarcinoma requiring neoadjuvant chemoradiotherapy as per RMH clinical guidelines.\n* Patients suitable for concomitant chemotherapy\n* Patients with disease included within treatment field size of MR-Linac.\n* WHO Performance status 0-2\n* Ability of the participant understand and the willingness to sign a written informed consent form.\n* Ability\u002Fwillingness to comply with the patient reported outcome questionnaires schedule throughout the study.\n\nExclusion Criteria:\n\n* Contraindications to MRI (e.g. pacemaker, potentially mobile metal implant, claustrophobia)\n* Disease outside maximum radiotherapy treatment field length.\n* Comorbidities which predispose to significant toxicity (e.g. inflammatory bowel disease) or preclude long term follow up\n* Unilateral or bilateral total hip replacement, or other pelvic metalwork which causes artefact on diffusion-weighted imaging\n* Previous pelvic radiotherapy\n* Patients needing induction chemotherapy prior to chemoradiotherapy\n* Previous invasive malignancy within the last 2 years excluding basal or squamous cell carcinomas of the skin, low risk non-muscle invasive bladder cancer (assuming cystoscopic follow up now negative) or small renal masses on surveillance.",{"count":578,"type":22},13,[25],"Standard radiotherapy in the UK involves having daily chemotherapy tablets with radiotherapy treatment for 5 weeks at a dose of 52.5Gy to the rectal cancer over 25 fractions. This is the likely treatment participants will be having if they decide not to take part in this study. Increasing the dose to 60Gy is shown to increase the chance that rectal cancer will be treated completely, a term known as \"complete pathological response\". Patients who have a complete pathological response after their treatment can avoid surgery and enter into a surveillance programme to monitor for early signs of the cancer returning. Surveillance can mean 3-6 months camera tests and MRI scans depending on the local unit. If these patients continue to show signs of complete pathological response then they can avoid long term complications from surgery such as a stoma. Unit studies have shown that that increasing the dose of radiotherapy can cause slightly more bowel and bladder side effects, but using adaptive radiotherapy to limit radiotherapy to normal tissue could keep the rate of bothersome side effects as low, which is similar as standard treatment.\n\nAll adaptive treatments within this trial will be delivered on a state of the art, radiotherapy machine called an MR-linac (Magnetic Resonance Linear Accelerator). It combines an MRI scanner with a radiotherapy treatment machine called a Linear Accelerator (called a 'linac' for short). The use of the MR-linac means there is no extra radiation dose given when taking daily images to check for the position of participants rectal cancer (unlike CT scans or X-ray). It also enables the investigators to adapt or 'tweak' the radiotherapy plan each day to match the exact position of the rectal cancer and adjacent organs. The non-adaptive fractions can be delivered on either the MR-Linac or CT-linac depending on factors such as treatment machine availability.\n\nThe investigators will deliver the treatment on the MR-linac using a technique called intensity modulated radiotherapy (precise X-ray treatment, called IMRT for short). IMRT is able to mould radiotherapy treatment according to what the investigators can see, therefore enabling the investigators to give highly targeted treatment. The investigators already have considerable experience in delivering radiotherapy to rectal cancer with this machine and now wish to focus on whether they could increase dose to benefit long term outcome for all rectal cancer patients as well as reducing the side effects of treatment.\n\nThe purpose of this research is to increase the dose to rectal cancer while adapting to the changes that the investigators can see to the rectal cancer during treatment. This means that if the rectal cancer is seen to reduce in size they will be able to deliver a 'shrinking boost' according to what can be seen. This will enable the investigators to give high dose radiotherapy to the cancer whilst limiting radiotherapy to healthy tissue. Without the ability to adapt to changes that the investigators see to the tumour throughout the entire treatment course, standard treatment delivers dose to a larger area of surrounding healthy tissue to ensure that the tumour is sufficiently targeted.\n\nThe investigators want to find out if by using this adaptive, shrinking boost approach, they can safely increase radiotherapy dose to rectal cancer, whilst limiting the side effects you experience, in comparison with standard treatment. If this is possible, then this would lead into further clinical trial where the investigators would compare outcomes of higher-dose treatment to standard-of-care. The investigators can't be certain that the side effects will be different, and they don't know if this treatment results in the best chance of cancer cure. However they know from other studies that this is the likely outcome, with surgery being delayed for patients. Patients who have a complete pathological response after combined chemotherapy and radiotherapy treatment enter into a surveillance programme where MRI and camera tests (flexible sigmoidoscopy) are performed at regular intervals looking for early signs of cancer returning.\n\nThe investigators expect that the chance of participants having a complete pathological response with this technique is higher than with standard dose, although the investigators can't know this for sure until they have completed further studies. It is possible that the cure rate may be lower or higher than the standard dose.",[582],"Rectal Adenocarcinoma","2025-02-25",{"date":585,"type":37},"2025-03-03",{"date":587,"type":37},"2025-02-14",{"date":589,"type":22},"2029-01-13",{"name":43,"class":44},{"id":592,"slug":593,"hasResults":12,"nctId":594,"briefTitle":595,"officialTitle":596,"acronym":597,"eligibilityCriteria":598,"healthyVolunteers":286,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":599,"targetDuration":4,"studyType":23,"phases":600,"briefSummary":601,"conditions":602,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":613,"lastUpdatePostDateStruct":614,"startDateStruct":616,"completionDateStruct":618,"leadSponsor":620,"locationsCount":45},"100570811","video-capsule-examination-in-patients-with-lynch-syndrome-100570811","NCT06712095","Video Capsule Examination in Patients With Lynch Syndrome","Video Capsule Examination in Patients With Lynch and Other Cancer-predisposition Syndromes - a Proof-of-concept Study for Obtaining Data to Support the Development of Machine Learning Algorithms to Detect Early Cancers","PILLCAM","Inclusion Criteria:\n\n* Patients over the age of 18 years old with no active cancer\n* No previous resection of the colon and\u002For rectum\n* Carriers of a pathogenic\u002Flikely pathogenic variant in any of the following cancer-predisposition genes: Lynch syndrome (MLH1, MSH2, MSH6, PMS2), APC (FAP syndrome); biallelic MUTYH; STK11 (Peutz-Jeghers syndrome); PTEN, CDH1, CHEK2, TP53, BMPR1A and SMAD4 (Juvenile polyposis syndrome)\n* Able to consent to the study and undergo colonoscopy.\n\nExclusion Criteria:\n\n* Extensive surgery which poses a high risk of video-capsule blockage or narrowing of the bowel due to extensive tumour. Extensive surgery implies any removal of large portions of the small or large bowel that might cause a narrowing (stricture) in the digestive tract.\n* Previous irradiation to abdomen or pelvis (risk for small bowel obstruction)\n* Carriers of a variant associated with reduced penetrance (in the view of a geneticist) or a variant of uncertain significance.\n* Patients with a PS of 3 or 4 and\u002For mobility issues\n* Pregnancy\n* Pacemaker or internal electro-medical device (artificial heart valve, cochlear implant or an internal electromedical device).\n* Insulin-dependent diabetes\n* Patients who require deep sedation for colonoscopy",{"count":7,"type":22},[25],"Surveillance for colorectal cancer (CRC) in patients predisposed to develop CRC during their lifetime has been impacted by access to colonoscopy suites and endoscopy specialists in the past couple of years. An alternative method, namely the colon capsule, has been proposed, however this investigation is time consuming for the clinician and the images require up to one hour (30-60 minutes) reading to issue a result. The investigators propose to obtain images from paired colonoscopies and colon capsules with the purpose of developing an AI algorithm which could aid the clinicians in reading the colon and expand access to this investigation.\n\nThe main aim of the study is to determine whether it is possible to obtain usable paired images from patients with Lynch and other cancer predisposition syndromes. This will depend on the willingness of the patients to take part in the study and the technical ability of obtaining data from paired images of colonoscopies and colon capsule.\n\nAt recruitment, participants will undergo a colon capsule investigation, followed by a routine colonoscopy as per their normal standard of care. Paired endoscopic images from colonoscopies and colon capsules will be collected and anonymised data will be accessed by the bioinformatician for analysis.\n\nIf the study will be successful in reaching the primary endpoint, further trials will be opened, allowing for a larger population to be included and to obtain more robust data, which eventually can lead to validated AI algorithms and application of computer-aided video-capsules examination as a screening tool in at-risk population.",[603,604,605,606,607,608,609,610,611,612],"Lynch Syndrome","Li Fraumeni Syndrome","PTEN Hamartoma Syndrome","FAP","MUTYH Biallelic Mutation","STK11 Mutation","CDH1 Gene Mutation","CHEK2 Gene Mutation","BMPR1A Gene Mutation","SMAD4 Gene Mutation","2024-12-03",{"date":615,"type":37},"2024-12-05",{"date":617,"type":37},"2024-03-04",{"date":619,"type":22},"2025-10-31",{"name":43,"class":44},{"id":622,"slug":623,"hasResults":12,"nctId":624,"briefTitle":625,"officialTitle":626,"acronym":627,"eligibilityCriteria":628,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":629,"targetDuration":4,"studyType":23,"phases":631,"briefSummary":632,"conditions":633,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":613,"lastUpdatePostDateStruct":635,"startDateStruct":636,"completionDateStruct":638,"leadSponsor":640,"locationsCount":641},"100438129","phase-2-a-trial-of-early-detection-of-molecular-relapse-with-circulating-tumour-dna-tracking-and-treatment-with-palbociclib-plus-fulvestrant-versus-standard-endocrine-therapy-in-patients-with-er-positive-her2-negative-breast-cancer-100438129","NCT04985266","A Trial of Early Detection of Molecular Relapse With Circulating Tumour DNA Tracking and Treatment With Palbociclib Plus Fulvestrant Versus Standard Endocrine Therapy in Patients With ER Positive HER2 Negative Breast Cancer","A Randomised Trial of Early Detection of Molecular Relapse With Circulating Tumour DNA Tracking and Treatment With Palbociclib Plus Fulvestrant Versus Standard Endocrine Therapy in Patients With ER Positive HER2 Negative Breast Cancer","TRAK-ER","Inclusion Criteria for ctDNA Surveillance:\n\n1. Written informed consent to participate in the trial and to donation of tissue and blood samples\n2. Male or female patients aged 18 years or older\n3. ECOG performance status 0, 1 or 2 (see https:\u002F\u002Fecog-acrin.org\u002Fresources\u002Fecog-performance-status)\n4. Histologically proven primary ER+ (Allred score 6\u002F8 or greater, or stain in ≥10% of cancer cells) and HER2- (immunohistochemistry 0\u002F1+ and\u002For negative by in situ hybridization) breast cancer as determined by local laboratory\n5. Patients with high risk early stage breast cancer according to at least one of the following criteria:\n\n   Primary surgery (no other treatment prior to surgery) A. Four or more involved axillary lymph nodes or positive supraclavicular lymph node at diagnosis, or\n\n   B. Tumour size \\> 5 cm, regardless of lymph node status, or\n\n   C. 1-3 involved axillary lymph nodes and at least one of the following; i) Tumour size \\> 3 cm, ii) histological grade 3 iii) high genomic risk defined as Oncotype Dx Recurrence Score \\>=26, Prosigna score \\>=60, EPclin risk score \\>=4.0, or Mammaprint high risk category, or\n\n   Neoadjuvant chemotherapy (chemotherapy prior to surgery)\n\n   D. At least one lymph node positive (micrometastasis or macrometastasis) after chemotherapy\n\n   E. Lymph node negative and tumour size \\> 3 cm after chemotherapy\n\n   Neoadjuvant endocrine therapy (endocrine based therapy prior to surgery) Use the primary surgery criteria - staging tumour size and lymph node status may be either the pathological staging after endocrine therapy or on the initial clinical staging prior to neoadjuvant therapy\n6. Available tissue from one archival tumour tissue sample (either from diagnostic biopsy, primary surgery or where available residual disease post-neoadjuvant chemotherapy)\n7. No evidence of macroscopic distant metastatic disease or incurable locally advanced disease on staging scans conducted at any time since initial diagnosis.\n8. Patients receiving standard endocrine therapy with aromatase inhibitors (letrozole, anastrazole, exemestane), tamoxifen, or combination of such for a minimum of 6 months\\* and maximum of 7 years duration with an additional three years of endocrine therapy planned. Pre- or peri-menopausal patients may also receive GnRH analogues.\n\n   \\* patients may enrol during the first 6 months of standard endocrine therapy, and wait until at least 6 months of endocrine therapy has been received prior to starting ctDNA surveillance\n9. Patients must have had surgery achieving clear margins (as per local guidelines)\n10. Female and male patients of reproductive potential must be willing to use an adequate method of contraception for the first three years of the trial, if randomised to standard endocrine therapy for the duration of trial treatment through to at least 4 weeks after the last dose of trial treatment, and if randomised to fulvestrant and palbociclib to 2 years after the last dose of fulvestrant (see section 4.6). Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient.\n11. Patients willing to have frequent blood tests.\n\nInclusion Criteria for Interventional phase:\n\n1. Signed informed consent for treatment\n2. ECOG performance status 0, 1 or 2\n3. Women of childbearing potential should have a negative serum pregnancy test prior to randomisation. If randomisation occurs more than 72 hours prior to receiving the first dose of treatment the test must be repeated before treatment.\n4. Female and male patients of childbearing potential must be willing to use an adequate method of contraception (section 4.6), starting with the first dose of treatment through 4 weeks after the last dose of treatment if randomised to standard endocrine therapy and 2 years after the last dose of fulvestrant if randomised to fulvestrant and palbociclib. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient. Female patients will be deemed not of childbearing potential if they are postmenopausal or have had irreversible sterilisation\n5. Patient has adequate bone marrow and organ function as defined by the following laboratory values:\n\n   1. Absolute Neutrophil Count (ANC) ≥ 1.5 × 109\u002FL\n   2. Platelets ≥ 100 × 109\u002FL\n   3. Haemoglobin ≥ 100 g\u002FL\n   4. INR ≤1.5\n   5. Creatinine \\\u003C1.5 x ULN and creatinine clearance ≥30ml\u002Fmin\n   6. Total bilirubin \\\u003C ULN except for patients with Gilbert's syndrome who may only be included if the total bilirubin is ≤ 3.0 × ULN or direct bilirubin ≤ 1.5 × ULN.\n   7. Alanine aminotransferase (ALT) \\\u003C 2.5 x ULN\n   8. Aspartate aminotransferase (AST) \\\u003C 2.5 × ULN\n6. Patients must be post-menopausal OR\n\nPre- or peri-menopausal patients or men may be enrolled if they have ovarian\u002Fgonadal suppression with licensed GnRH analogues. Patients must have commenced licensed GnRH analogues at least 2 weeks prior to Cycle 1 Day 1 and continue throughout the study if randomised to fulvestrant and palbociclib.\n\nPost-menopausal female patients, as defined by at least one of the following:\n\n* Age ≥60 years;\n* Age \\\u003C60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause, and serum estradiol and FSH levels within the institutional laboratory's reference range for post-menopausal females;\n* Documented bilateral oophorectomy;\n\nExclusion Criteria for ctDNA Surveillance:\n\n1. Any concurrent or planned treatment for the current diagnosis of breast cancer other than adjuvant endocrine therapy or a bisphosphonate.\n2. Patients with prior exposure to a CDK 4\u002F6 inhibitor as part of standard of care may enrol only after at least 12 months from completing CDK4\u002F6 therapy.\n3. Prior exposure to therapeutic dose of fulvestrant is not permitted. One subtherapeutic dose of fulvestrant is permitted.\n4. Prior diagnosis of cancer including prior diagnosis of breast cancer in the previous 5 years, other than for non-melanoma carcinoma of the skin or cervical carcinoma in situ\n5. Patients previously entered into a therapeutic trial where experimental therapy is continued post-surgery. Patients who have entered a clinical trial of a CDK4\u002F6 inhibitor in the adjuvant setting are not eligible. Patients who received a CDK4\u002F6 inhibitor only before an operation, with no post-operative adjuvant use, are eligible.\n6. Treatment with an unlicensed or investigational product within 4 weeks prior registration to trial\n7. Patient has not recovered to ≤ grade 1 (except alopecia or certain other toxicities, which in the opinion of the Investigator should not exclude the patient) from related side effects of any prior antineoplastic therapy, not including side-effects of endocrine therapy\n8. Patient with impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral medication (e.g. Crohn's disease, ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome, or small bowel resection)\n9. Patient has any other concurrent severe and\u002For uncontrolled medical condition that would, in the Investigator' opinion cause unacceptable safety risks, contraindicate patient participation in the clinical trial or compromise compliance with the protocol.\n10. Clinically significant uncontrolled heart disease including any of the following:\n\n    1. History of myocardial infarction (MI), angina pectoris, symptomatic pericarditis, or coronary artery bypass graft (CABG) within 6 months prior to trial entry\n    2. Symptomatic congestive heart failure\n    3. Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome.\n    4. Cardiac arrhythmia.\n11. History of pneumonitis, interstitial lung disease or pulmonary fibrosis\n12. Known history of Human Immunodeficiency Virus (HIV) (testing not required as part of study screening)\n13. Known active Hepatitis B or Hepatitis C (testing not required as part of study screening)\n14. Females who are known to be pregnant or breastfeeding\n15. History of bleeding diathesis (i.e. disseminated intravascular coagulation, clotting factor deficiency), other known abnormalities in coagulation or treatment with anticoagulants. Low molecular weight heparin (LMWH), low dose aspirin or clopidogrel are permitted.\n16. Child-Pugh class C hepatic impairment or creatinine clearance \\\u003C 30ml\u002Fmin.\n17. Patient with bilateral tumours, or unilateral multifocal cancers with multiple separate primary cancers.(Multifocal cancer that reflects a single primary cancer, in the opinion of the investigator, are eligible)\n\nExclusion Criteria for Interventional phase:\n\n1. Evidence of recurrent disease (metastatic or local, see section 6.6 for management of patients with potentially curable local recurrences) on staging scans conducted since positive ctDNA result\n2. Known hypersensitivity to the excipients of palbociclib plus fulvestrant\n3. Any anti-cancer treatment since enrolling in the TRAK-ER study other than hormonal therapy or a bisphosphonate. Prior exposure to fulvestrant is not permitted.\n4. Diagnosis of an alternative cancer since enrolment in the trial other than non-melanoma cancer of the skin or cervical carcinoma in situ\n5. Patient has had major surgery within 4 weeks prior to starting trial treatment or has not recovered from major side effects of such procedure\n6. Patient is currently receiving warfarin or other coumarin derived anti-coagulant, for treatment, prophylaxis or otherwise. Therapy with unfractionated heparin, low molecular weight heparin (LMWH), or a direct-acting oral anticoagulant (DOAC such as rivaroxaban or fondaparinux) is allowed\n7. Patient has not recovered to ≤ grade 1 (except alopecia or certain other toxicities, which in the opinion of the Investigator should not exclude the patient) from related side effects of any prior antineoplastic therapy, not including side-effects of endocrine therapy\n8. Patient with impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral medication (e.g. Crohn's disease, ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome, or small bowel resection)\n9. Patient has any other concurrent severe and\u002For uncontrolled medical condition that would, in the Investigator' opinion cause unacceptable safety risks, contraindicate patient participation in the clinical trial or compromise compliance with the protocol.\n10. Clinically significant uncontrolled heart disease including any of the following:\n\n    1. History of myocardial infarction (MI), angina pectoris, symptomatic pericarditis, or coronary artery bypass graft (CABG) within 6 months prior to trial entry\n    2. Symptomatic congestive heart failure\n    3. Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome.\n    4. Cardiac arrhythmia.\n11. Patient is currently receiving any of the following substances and cannot be discontinued 7 days prior to Cycle 1 Day 1:\n\n    * Medications that are strong inducers or inhibitors of CYP3A4 (section 8.5.2)\n    * Herbal preparations\u002Fmedications, dietary supplements, fruits (e.g grapefruit, pomelos, starfruit, Seville oranges) and their juice\n12. History of pneumonitis, interstitial lung disease or pulmonary fibrosis\n13. Known history of HIV (testing not required as part of study screening)\n14. Known active Hepatitis B or Hepatitis C (testing not required as part of study screening)\n15. Patient has a history of non-compliance to medical regimen\n16. History of bleeding diathesis (i.e. disseminated intravascular coagulation, clotting factor deficiency), other known abnormalities in coagulation or treatment with anticoagulants. Low molecular weight heparin (LMWH), low dose aspirin or clopidogrel are permitted.\n17. Females who are known to be pregnant or breastfeeding.",{"count":630,"type":22},1100,[363],"Detection of molecular relapse with circulating tumour DNA analysis can identify which patients with ER positive breast cancer are relapsing on adjuvant endocrine therapy. This trial will aim to demonstrate that palbociclib and fulvestrant, can defer or prevent relapse in patients with ctDNA detected molecular relapse.\n\nThe TRAK-ER trial will have two phases, a ctDNA surveillance phase and a randomised therapy trial in patients with positive ctDNA.\n\nThe TRAK-ER trial will establish a ctDNA screening programme for patients with ER positive breast cancer receiving adjuvant endocrine therapy with at least a further three years of standard adjuvant endocrine therapy planned. Patients recruited into the TRAK-ER study will have high-risk clinical features to identify patients at higher risk of future relapse.\n\nctDNA assays will be used to identify which people are at very high risk of relapse (i.e. those with a positive ctDNA result), and randomise this high risk population between standard endocrine therapy versus palbociclib plus fulvestrant for up to two years.",[90,634],"HER2-negative Breast Cancer",{"date":615,"type":37},{"date":637,"type":37},"2022-03-30",{"date":639,"type":22},"2030-09-01",{"name":43,"class":44},49,""]