[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"The Christie NHS Foundation Trust\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":470},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,19,0,[8,45,72,104,125,152,181,202,223,248,271,286,310,332,358,379,406,430,448],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100526582","preoperative-preradiotherapy-ttfields-100526582",false,"NCT06136611","Preoperative Preradiotherapy TTFields","Preoperative Preradiotherapy TTFields (PORTRAIT)","PORTRAIT","Inclusion Criteria:\n\n* Patient is aged \\>35 years (age range of more likely to suffer from an IDHwt World Health Organisation (WHO) grade 4 astrocytoma)\\*\n* Patient is male or female.\n* Patient has a new radiological diagnosis of glioblastoma.\n* Patient has a performance status judged by WHO, Eastern Cooperative Oncology Group (ECOG) score = 0-1.\n* Patient has been reviewed by Neuro-oncology multidisciplinary team (MDT - neurosurgeon, clinical oncologist, radiologist and pathologist); MDT consensus that offering study entry is clinically appropriate and safe i.e. patient unlikely to come to harm (e.g. hydrocephalus) from delayed surgery and pre-operative Optune based on available clinical information and imaging.\n* PI has confirmed at the first clinic visit that study entry is clinically appropriate and safe (e.g. lack of severe and debilitating symptoms of raised intracranial pressure).\n* There is intention to treat the patient with surgical resection and postoperative adjuvant therapy as per current standard of care (40Gy\u002F15 fr or 60Gy\u002F30fr).\n* Patient has adequate haematological and biochemical parameters for surgery and contrast agent administration (full blood count and coagulation profile deemed acceptable by clinical team, eGFR \\>30ml\u002Fmin).\n* Patient has mental capacity to consent for treatment.\n* Patient is able and willing to give informed consent\n\nCriteria specific to the experimental arm:\n\n* Patient is able and willing to comply with study protocol requirements to continuously shave their head\n* Patient is able and willing to comply with study protocol requirements to wear Optune equipment for the required duration.\n\nExclusion Criteria:\n\n* Patients with uncontrolled seizures.\n* Patients are due to undergo a planned biopsy procedure only.\n* Patients have a suspicion of other tumour on CT body scan or known malignancy except non-melanoma skin cancer, completely resected or prostate cancer (with Prostate Specific Antigen of less than or equal to 0.1 ng\u002Fml) within the past three years.\n* Patients have contraindications to contrast-enhanced MRI scanning (e.g. claustrophobia, gadolinium allergy).","ALL","35 Years",{"count":20,"type":21},42,"ESTIMATED","INTERVENTIONAL",[24],"NA","PreOperative PreRAdIotherapy Tumour Treating Fields (PORTRAIT) is a Phase I study that will test the safety and feasibility of Optune administered preoperatively and preradiotherapy in patients with a new radiological diagnosis of glioblastoma (GBM). Participants will be required to undergo additional MRI sequencing scans and provide blood, tear fluid and tissue samples over a maximum of 6 months. After the study patients will follow their standard treatment pathway.",[27],"Glioblastoma",[29,30,31],"Neoadjuvant","Preoperative","Tumour Treating Fields","RECRUITING","2026-05-05",{"date":35,"type":36},"2026-05-08","ACTUAL",{"date":38,"type":36},"2024-12-19",{"date":40,"type":21},"2026-12-30",{"name":42,"class":43},"The Christie NHS Foundation Trust","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100569534","enabling-genomic-testing-in-cancer-of-unknown-primary-100569534","NCT06695494","Enabling Genomic Testing in Cancer of Unknown Primary","EGGCUP","Inclusion Criteria:\n\n1. Aged 16 years or over\n2. Written informed consent according to ICH\u002FGCP and national regulations\n3. ECOG Performance status 0-2\n4. Confirmed diagnosis of CUP as per the ESMO guidelines. Patients must have;\n\n   1. The local pathology reports confirming compatibility with CUP diagnosis and the associated slides used for the diagnosis\n   2. Discussion at a local CUP MDT confirming diagnosis\n5. Availability of archival tumour histological report\n6. Willingness to provide blood samples on up to two occasions during the study\n\nExclusion Criteria:\n\n1. Patient with an immunohistochemistry profile that provides a definitive clinical indication of a primary cancer with a specific treatment\n2. Known HIV, Hepatitis B, C positive, due to the difficulties in handling high-risk specimens\n3. Patients who are unable to provide fully informed written consent\n4. Presence of any medical, psychological, familial or sociological condition that, in the investigator's opinion, will hamper compliance with the study protocol and follow-up schedule\n5. Bleeding diathesis (patients' on anticoagulation are permitted to enter the trial if anticoagulation can be safely managed to enable blood sampling)\n6. Conditions in which blood sampling may increase risk of complications for the patients and\u002For investigator","16 Years",{"count":54,"type":21},100,"OBSERVATIONAL","Cancer of Unknown Primary (CUP) is where cancer cells are found in the body but the place the cancer began is not known. It is the 6th leading cause of cancer death in the UK and the prognosis is poor with a median survival of 6-9 months. There is a higher than average incidence of CUP in the North West (NW) of England (population of 7.4 million). Precision medicine has transformed treatment strategies in known tumour types, however in CUP there remains an urgent need to better understand CUP molecular characteristics to establish potential roles for novel therapeutic strategies. Treatment options remain limited due to difficulties in determining the primary site of the tumour and the lack of access to validated biomarkers. Access to good-quality tissue for molecular profiling remains a huge challenge in CUP. The emergence of liquid biopsies (sequence DNA in a blood test) as a source of biomarkers is also gaining rapid ground and this study aims to explore the potential utility of liquid biopsies in CUP.",[58,59],"Cancer of Unknown Primary","Neoplasm, Unknown Primary",[61,62],"Cancer of unknown primary","Cancer","2026-03-24",{"date":65,"type":36},"2026-03-25",{"date":67,"type":36},"2024-08-15",{"date":69,"type":21},"2027-12-01",{"name":42,"class":43},6,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":80,"maxAge":52,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":89,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":44},"100607031","using-red-light-therapy-to-ease-skin-side-effects-and-mouth-side-effects-in-children-and-young-people-aged-0-to-16-years-old-receiving-radiotherapy-100607031","NCT07183267","Using Red Light Therapy to Ease Skin Side Effects and Mouth Side Effects, in Children and Young People Aged 0 to 16 Years Old, Receiving Radiotherapy","Reducing rAdiation aDverse Effects of dermatitIs and mucosAl inflammatioN Using Red Light Therapy","RADIANT","Inclusion Criteria:\n\n* Paediatric patient receiving a treatment course of either proton or photon therapy - Craniospinal treatment field, Head and Neck treatment fields and body treatment fields.\n\nExclusion Criteria:\n\n* Paediatric patients receiving focal brain only proton or photon radiotherapy.\n* Paediatric patients receiving a single fraction of proton or photon therapy.\n* Total Body Irradiation patients.","0 Years",{"count":82,"type":21},248,[24],"The goal of this interventional study is to see if the daily use of red light therapy called photobiomodulation can help sore skin and sore mouths in children having radiotherapy.\n\nAll children aged 0-16 years old who are receiving either proton or photon radiotherapy treatment, except to the brain only, will be asked if they would like to join the study.\n\nThe main questions it aims to answer are:\n\n1. Does the use of red light therapy help the skin side effects in children and young people undergoing proton or photon therapy?\n2. Does the use of red light therapy help the mouth side effects in children and young people undergoing proton or photon therapy in the head and neck area?\n\nResearchers will compare the patients enrolled on to the study with a like for like historic patient to see if red light therapy improves the sore skin and sore mouths caused by proton or photon therapy.\n\nParticipants will have a daily treatment with red light therapy alongside their daily proton or photon treatment fraction.",[86,87,88],"Radio Dermatitis","Mucositis Oral","Oesophagitis",[90,91,92,93,94],"Paediatric skin toxicity","paediatric oral mucositis","paediatric proton therapy","paediatric radiotherapy","paediatric photon therapy","NOT_YET_RECRUITING","2026-03-17",{"date":98,"type":36},"2026-03-19",{"date":100,"type":21},"2026-06-01",{"date":102,"type":21},"2028-10-01",{"name":42,"class":43},{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":44},"100615514","investigation-of-the-role-of-fat-and-inflammatory-cells-in-melanoma-100615514","NCT07293598","Investigation of the ROle of faT and inflAmmaTory Cells in mElanoma","A Clinical, Histological, Cellular and Molecular Investigation of the Role of Fat and Inflammatory Cells in Melanoma Plasticity and Metastases","ROTATE","Inclusion Criteria:\n\n1. Melanomas treated between 1st January 2006 and 31st December 2015 OR\n2. Patients treated at the Christie between 2014 and 2019.\n3. Review of histological slides for presence or absence of relevant histological features.\n\n   For group 3 and group 4:\n4. Unique features of spitzoid melanomas\n\nExclusion Criteria:\n\n* Inadequate slide quality\n* Unable to view the entire cross section of the skin with the primary tumour hence, unable to assess the invasion of inflammatory cells into fat",{"count":113,"type":21},20,"This study is a retrospective, proof-of-concept sample study to investigate a novel histological finding within the primary melanoma tumour in a large population of melanoma patients to assess its prognostic significance.\n\nThis is a aims to validate the striking observation that a cross-talk between fat cells and leukocytes at the primary melanoma site promotes metastasis. In our unpublished pilot study, we have discovered an interesting finding whereby inflammatory cells extend from the tumour to and invading fat in the subcutaneous tissue and\u002For around the appendageal structures in the dermal skin in metastatic melanomas with distinct architectural changes within the fat. This finding was consistently present in metastatic and absent in non-metastatic melanomas. This new finding has both clinical and pathophysiological credence. Archival tissue blocks or human cell lines will be used in the first instance. As mitigation, experiments will be repeated with conditioned media obtained from co-culture of mixed primary immune cells obtained from peripheral blood mononuclear cell (PBMCs) and adipocytes induced from stem cells.\n\nThis study aims to:\n\n* Investigate if the crosstalk between fat cells and tumour-infiltrating inflammatory cells defines the aggressiveness of primary cutaneous melanomas.\n* Identify and perform biological spatial analysis of the inflammatory cells between the tumour and fat in the primary tumours.\n* Investigate the interactions of fat cells and\u002For inflammatory cells in mediating melanoma cellular plasticity.\n\nThe patients have not provided consent and will be justified in this application",[116],"Melanoma (Skin Cancer)","2025-12-08",{"date":119,"type":36},"2025-12-19",{"date":121,"type":21},"2026-01",{"date":123,"type":21},"2027-01",{"name":42,"class":43},{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":22,"phases":135,"briefSummary":137,"conditions":138,"keywords":140,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":44},"100613572","phase-3-a-phase-iii-randomised-control-clinical-trial-of-radiotherapy-with-radiosensitisation-versus-intravesical-bacillus-calmette-guerin-therapy-for-high-risk-non-muscle-invasive-bladder-cancer-100613572","NCT07268339","A Phase III Randomised Control Clinical Trial of Radiotherapy With Radiosensitisation Versus Intravesical Bacillus Calmette-Guerin Therapy for High-risk Non-muscle Invasive Bladder Cancer.","TRAIN - A Phase III Randomised Control Clinical Trial of Radiotherapy With Radiosensitisation Versus Intravesical Bacillus Calmette-Guerin Therapy for High-risk Non-muscle Invasive Bladder Cancer.","TRAIN","Inclusion Criteria:\n\n* Diagnosed with histologically confirmed grade 3 T1 N0 M0 transitional cell carcinoma, OR carcinoma in situ of the bladder (and N0 M0), OR both, with detrusor muscle present in the biopsy specimen if T1 disease (or a repeat resection that does contain muscle that is clear)\n* Suitable for BCG treatment\n* Suitable for radiotherapy and radiosensitisation according to the schedule of administration outlined in the Radiotherapy Planning Guidance document.\n* Life expectancy over 12 months\n* ECOG performance status 0 - 2\n* Age \\>=16 years\n* Provided written informed consent\n\nExclusion Criteria:\n\n* MDT selected patients with HR-NMIBC who are deemed best suited for primary cystectomy (patients that have had this treatment recommendation but then decline cystectomy remain eligible for TRAIN)\n* Previous radiotherapy to the pelvis\n* Previous intravesical therapy\n* Poor bladder function (IPSS \\>16)\n* A recent or current other cancer. Current non-melanoma skin cancer, cervical carcinoma in situ or localized prostate cancer not requiring current treatment are permissible, as is a history of a separate other malignancy having completed all active treatment ≥2 years previously and without evidence of relapse\n* Pre-existing medical conditions that preclude treatment options in either trial arm\n* Patient currently recruited to another interventional trial or participation within an interventional clinical trial within 3 months of the point of registration within TRAIN.\n* Pregnant or breast-feeding\n* Not able to use appropriate adequate effective contraception during and for 3 months after the study",{"count":134,"type":21},328,[136],"PHASE3","In the UK 20,000 people develop urothelial bladder cancer each year with 75-80% having Non-Muscle Invasive Bladder Cancer (NMIBC). The current standard of care for patients with High Risk-NMIBC (HR-NMIBC) is either surgery to remove the tumour (transurethral resection of bladder tumour; TURBT) followed by BCG (Bacillus Calmette Guérin, an immunotherapy drug) given directly into the bladder, or surgery to remove the bladder (cystectomy). BCG is given weekly for six weeks followed by maintenance treatment up to 3 years. However, in up to 50% of patients their cancer returns (recurrence) or gets worse (progression) after BCG and 25% stop treatment due to side effects. Globally BCG supply has been restricted in recent years has increased HR-NMIBC recurrence rates and costs. Improved treatments are required, to prevent recurrence, progression and cystectomy, and mitigate the effects of unpredictable supply.\n\nTrimodality treatment (TMT) is maximal TURBT + radiotherapy + a radiosensitiser (gemcitabine, mitomycin C\u002Ffluorouracil or carbogen\u002Fnicotinamide) and is an equivalent alternative treatment to cystectomy for muscle-invasive bladder cancer (MIBC). TMT is not routinely used for HR-NMIBC. A study found that 54% of HR-NMIBC patients who received TMT did not have recurrence within 5 years. Modern radiotherapy is expected to further improve outcomes and minimise side-effects.\n\nPatients will be randomised 1:1 to BCG or radiotherapy with radiosensitisation. Patients randomised to the experimental arm will receive 55Gy in 20 fractions. Investigators can then choose from three different options for the radiosensitiser. TRAIN will test if radiotherapy with radiosensitisation improves outcomes for people with HR-NMIBC compared to BCG.\n\nTRAIN will recruit 328 patients with HR-NMIBC following maximal TURBT. All patients will be followed up for a minimum of two years to record their response to treatment.",[139],"High-Risk Non-Muscle Invasive Bladder Cancer",[141,142,143],"non-muscle invasive bladder cancer","radiotherapy with radiosensitisation drugs","Bacillus Calmette-Guerin therapy","2025-11-25",{"date":146,"type":36},"2025-12-05",{"date":148,"type":21},"2025-12-01",{"date":150,"type":21},"2031-12-01",{"name":42,"class":43},{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":17,"minAge":160,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":22,"phases":163,"briefSummary":164,"conditions":165,"keywords":167,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":44},"100590260","to-determine-whether-it-is-feasible-to-treat-patients-requiring-urgent-radiotherapy-diagnosed-with-metastatic-cord-compression-mscc-on-the-magnetic-resonance-linear-accelerator-mrl-in-a-single-appointment-and-compare-it-to-the-standard-of-care-radiotherapy-pathway-100590260","NCT06965101","To Determine Whether it is Feasible to Treat Patients Requiring Urgent Radiotherapy Diagnosed With Metastatic Cord Compression (MSCC) on the Magnetic Resonance Linear Accelerator (MRL) in a Single Appointment and Compare it to the Standard of Care Radiotherapy Pathway","Rapid Response MRI-Guided Palliative Radiotherapy","RESONATE","Inclusion Criteria:\n\n* Confirmed Diagnosis of MSCC\n* Referred for an 8Gy, Single Fraction of Radiotherapy\n* 18 years or older.\n* Able to give informed consent in writing or verbally.\n* Willing to complete patient experience questionnaire\n* Willing to have the research team review their case notes for up to 1 year following\n\nExclusion Criteria:\n\n* Participant does not have capacity and cannot give informed consent.\n* Any evidence of significant clinical disorder or laboratory finding which, in the opinion of the investigator, make it undesirable for the patient to participate in the study.\n* Participant is unwilling to allow researchers to access their clinical notes and diagnostic scans.\n* Participant is unwilling to complete an experience questionnaire\n* The participant cannot speak or understand English.\n\nExclusion Criteria MRL arm:\n\n* Any contraindications to MRI identified after MRI safety screening\n* Unable to tolerate MRI scanning\n* Uncontrolled pain\u002F poor pain control.\n* MSCC in the cervical spine.\n* More than one vertebral level of compression","18 Years",{"count":162,"type":21},72,[24],"The goal of this clinical trial is to understand whether the Magnetic Resonance Linear Accelerator (MRL) could expedite Radiotherapy treatment for Metastatic Cord Compression (MSCC) by removing the need for a planning CT (pCT) scan prior to treatment. Radiotherapy will be delivered in one appointment on the MRL and compared to the standard of care of two appointments: a CT scan and a Radiotherapy appointment.\n\nThe main questions it aims to answer are:\n\n* Can the MRL deliver successful treatment of MSCC in a single 1-hour appointment?\n* Can the MRL treat participants within 24 hours from the doctor's decision to treat?\n* Did it take less time from consent to completion of treatment when patients were treated on the MRL?\n* Do the questionnaire scores reflect satisfaction with treatment on the MRL? Researchers will compare treatment on the MRL in one appointment to a group receiving standard of care radiotherapy in two appointments.\n\nParticipants in both groups will receive the same prescription of 8Gray (Gy) in one treatment (fraction) delivered with one posterior-anterior beam as per our department policies and national standards.\n\nParticipants will be asked to complete an optional questionnaire prior to treatment to monitor the diversity of the study population. This questionnaire is anonymised, no personal data that could identify a participant is collected on this questionnaire.\n\nAfter treatment participants will be asked to complete an experience questionnaire, to assess treatment experience.\n\nOnce the questionnaire is complete active participation in the trial is no longer needed, researchers will monitor participants notes for up to 12 months after treatment to record participant well being and function.",[166],"Metastatic Spinal Cord Compression",[168,169,170,171,172,173],"Radiotherapy","MR Linac","MSCC","CT Sim Free","One Stop","MR Guided",{"date":175,"type":36},"2025-12-02",{"date":177,"type":36},"2025-11-04",{"date":179,"type":21},"2028-11-04",{"name":42,"class":43},{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":17,"minAge":160,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":191,"conditions":192,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":199,"leadSponsor":201,"locationsCount":44},"100508669","a-feasibility-study-of-mri-guided-stereotactic-ablative-radiotherapy-midsection-100508669","NCT05903430","A Feasibility Study of MRI Guided Stereotactic Ablative Radiotherapy (MIDSECTION)","A Feasibility Study of MRI Guided Stereotactic Ablative Radiotherapy","MIDSECTION","Inclusion criteria:\n\n1. Have no MRI contra-indications.\n2. Eligible for abdominal SABR in accordance with the NHSE SABR Consortium Guidelines or eligible for central lung SABR in accordance with RTOG Guidelines.\n3. Be able to give informed consent.\n4. Anticipated life-expectancy \\> 6 months.\n5. Not more than 3 oligmetastatic sites treated in total per patients.\n6. Performance status ≤ 2.\n7. Willing to attend follow-up and have details collected on prospective basis for a minimum of 1 year.\n\nExclusion criteria:\n\n1. Any contraindications to MRI identified after MRI safety screening including completion of an MRI Safety Screening Form.\n2. Unable to tolerate MRI scans.\n3. Any evidence of severe or uncontrolled systemic diseases which, in the view of the investigator make it undesirable for the patient to participate in the study.\n4. Any evidence of significant clinical disorder or laboratory finding which, in the opinion of the investigator, make it undesirable for the patient to participate in the study.\n5. Any patient known to have active hepatitis B, hepatitis C or human immunodeficiency virus (HIV).",{"count":190,"type":21},60,"To determine if the investigators are able to deliver highly focused, intense radiation to tumours in the abdominal region or chest cavity whilst limiting the dose to surrounding organs using a high field strength MR-Linac.",[193,194],"Abdominal Cancer","Lung Cancer","2025-08-29",{"date":197,"type":36},"2025-09-05",{"date":195,"type":36},{"date":200,"type":21},"2027-01-29",{"name":42,"class":43},{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":209,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":212,"conditions":213,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":44},"100420007","mri-development-for-radiotherapy-planning-and-delivery-in-non-patient-volunteers-100420007","NCT04749134","MRI Development for Radiotherapy Planning and Delivery in Non-Patient Volunteers","MINION","Inclusion Criteria:\n\n* Willing and able to provide written consent\n* Volunteers must undergo and satisfy MRI safety screening\n* Volunteers must be ≥ 16 years of age\n* Participants must agree to registration as a non-patient in CWP (the Trust's Electronic Health Record - EHR- system) and have their MRIs read and reported for incidental findings by a clinical radiologist\n\nExclusion Criteria:\n\n* Any contraindications to MRI identified after MRI safety screening including completion of an MRI Safety Screening Form\n* Unable to tolerate MRI scan\n* Known Pregnancy\n* Known or suspected pathology in body region to be scanned\n* Member of study team",true,{"count":211,"type":21},500,"Non-patient volunteers will be scanned on the MR-Linac and MRSIM to facilitate the development, optimisation and validation of MRI protocols at The Christie NHS Foundation Trust.",[214],"Focus of the Study is MRI Sequence Development","2025-08-19",{"date":217,"type":36},"2025-08-24",{"date":219,"type":36},"2021-08-01",{"date":221,"type":21},"2028-08-31",{"name":42,"class":43},{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":229,"eligibilityCriteria":230,"healthyVolunteers":11,"sex":17,"minAge":231,"maxAge":4,"enrollmentInfo":232,"targetDuration":4,"studyType":22,"phases":233,"briefSummary":234,"conditions":235,"keywords":237,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":4},"100577911","pencil-beam-scanning-proton-beam-radiotherapy-for-the-management-of-abdominal-neuroblastoma-100577911","NCT06804447","Pencil Beam Scanning Proton Beam Radiotherapy for the Management of Abdominal Neuroblastoma","Pencil Beam Scanning Proton Beam Radiotherapy for the Management of Abdominal Neuroblastoma - an Evaluative Commissioning in Protons (ECIP) Study","SUPERMAN","Inclusion Criteria:\n\n* Any patient with histologically confirmed abdominal or abdominal-pelvic neuroblastoma who are eligible and fit for radical radiotherapy.\n* Written informed consent from patient, parent or guardian - this includes consent for the minimum baseline, treatment and follow up assessments; and for their data to be stored and used for research, within the appropriate Proton Clinical Outcomes Units and NHS Proton Registry.\n* Patients registered female at birth of childbearing potential agree to use effective contraception between the planning Computed Tomography (CT) scan and the end of treatment.\n\nExclusion Criteria:\n\n* Pregnant patient","3 Months",{"count":54,"type":21},[24],"Proton Beam Therapy (PBT) and Evaluative Commissioning in Protons (ECIP):\n\nPBT is an advanced radiotherapy technique. There are two National Health Service (NHS) PBT treatment centres in the United Kingdom, in Manchester and London. The NHS is committed to ensuring the best use of this limited resource by investigating which patients will benefit from PBT. ECIP is a programme of studies exploring the role of PBT in different types of cancer funded by NHS England. ECIP studies are not randomised, eligible patients will be offered PBT. Any eligible UK patient can be referred, and accommodation is available for patients who don't live close to a PBT centre. The main benefit of PBT, compared with standard photon radiotherapy, is predicted reduction in radiation dose to surrounding healthy tissues. With photon radiotherapy, some radiation passes beyond the target area, affecting healthy tissues and causing side-effects. With PBT, the radiation dose stops within the target area, causing less damage to surrounding tissues, and limiting side effects.\n\nSUPERMAN:\n\nSUPERMAN is a study within the ECIP programme. It is sometimes not entirely clear whether PBT or photon radiotherapy is better for the treatment of a patient with abdominal neuroblastoma. The aim of SUPERMAN is to choose the best radiotherapy technique and to better understand how to monitor and adapt PBT for these patients.",[236],"Abdominal Neuroblastoma",[238,236,239],"Proton Beam Therapy","Evaluative Commissioning","2025-01-27",{"date":242,"type":36},"2025-02-03",{"date":244,"type":21},"2025-03-01",{"date":246,"type":21},"2030-03-01",{"name":42,"class":43},{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":254,"eligibilityCriteria":255,"healthyVolunteers":11,"sex":17,"minAge":160,"maxAge":4,"enrollmentInfo":256,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":258,"conditions":259,"keywords":261,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":44},"100478726","molecular-characterisation-of-colorectal-cancer-peritoneal-metastases-100478726","NCT05513716","Molecular Characterisation of Colorectal Cancer Peritoneal Metastases","Molecular Characterisation of Colorectal Cancer Peritoneal Metastases: Genomic and Transcriptomic Analysis With Correlation of Clinical Outcomes","COLOMET II","Participants are eligible to be included in the study only if all of the following criteria apply:\n\n1. Patients ≥ 18 years old who have been diagnosed with colorectal cancer and have colorectal peritoneal metastases,\n2. have had cytoreductive surgery at the Christie\n3. have availability of archival tumour tissue (paired CRC and CRPM)\n\nExclusion Criteria:\n\n* None",{"count":257,"type":21},200,"This project aims to characterise the tumour cell and tumour microenvironment of colorectal cancer peritoneal metastases, understand molecular changes leading to colorectal peritoneal metastasis, identify potential biomarkers and novel treatment strategies.",[260],"Colorectal Cancer Metastatic",[262],"Colorectal Cancer Peritoneal Metastatic","2024-12-31",{"date":265,"type":36},"2025-01-01",{"date":267,"type":36},"2024-02-04",{"date":269,"type":21},"2025-07-03",{"name":42,"class":43},{"id":272,"slug":273,"hasResults":11,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":4,"eligibilityCriteria":277,"healthyVolunteers":11,"sex":17,"minAge":160,"maxAge":4,"enrollmentInfo":278,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":279,"conditions":280,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":282,"startDateStruct":283,"completionDateStruct":284,"leadSponsor":285,"locationsCount":44},"100467286","molecular-characterisation-of-appendiceal-cancer-100467286","NCT05364788","Molecular Characterisation of Appendiceal Cancer","Characterisation of Appendiceal Cancer by Genomic and Transcriptomic Analysis and Correlation With Clinical Outcomes","Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\n1. Patients ≥ 18 years old who have been diagnosed with appendiceal cancer with peritoneal metastases,\n2. have had cytoreductive surgery\n3. have availability of archival tumour tissue\n\nExclusion Criteria:\n\n* None",{"count":54,"type":21},"Patients ≥ 18 years old who have been diagnosed with appendiceal cancer with peritoneal metastases, have had cytoreductive surgery, have availability of archival tumour tissue and have consented to our institutional biobank program or have a waiver of consent for deceased patients who have not had the opportunity to provide biobank consent (requested at the time of ethics review). Descriptive analysis of the proportion of genetic mutations identified in appendiceal cancers. This is given by the percentage of pathogenic mutations in the peritoneal metastasis compared to the primary tumour.",[281],"Appendiceal Cancer",{"date":265,"type":36},{"date":267,"type":36},{"date":269,"type":21},{"name":42,"class":43},{"id":287,"slug":288,"hasResults":11,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":292,"eligibilityCriteria":293,"healthyVolunteers":11,"sex":294,"minAge":160,"maxAge":4,"enrollmentInfo":295,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":297,"conditions":298,"keywords":300,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":309},"100565344","chronic-radiation-induced-bowel-toxicity-study-100565344","NCT06640959","Chronic Radiation Induced Bowel Toxicity Study","Chronic Radiation Induced Bowel Toxicity Study (CRIBS)","CRIBS","Inclusion Criteria:\n\n* Male, aged ≥ 18; no upper age limit and able to give informed consent.\n* Newly diagnosed patients with, histologically confirmed, localised, intermediate to high-risk prostate cancer (T2b -T4a N0 M0).\n* Patients to be treated with prostate radical radiotherapy IMRT (60Gy in 20# with curative intent) 4-week regimen.\n* Performance status - ECOG 0-2.\n\nExclusion Criteria:\n\n* Had received systemic antibiotics (intravenous, intramuscular, or oral) within 2 months before enrolment.\n* Had received cytotoxic or immunosuppressive therapies within 6 months of enrolment, including chemotherapy or immunotherapy.\n* Had consumed large doses of commercial probiotics (greater or equal to 108 CFU per day) within 12 months of enrolment (such as Actimint®, CranProBio®, ImmunoProBio®, among others).\n* Patients with diagnosed inflammatory bowel disease or coeliac disease\n* Patients with previous colorectal cancer\n* Patients who have undergone colectomy (total or subtotal)\n* Patients with a history of diverticulitis (uncomplicated diverticular disease permitted)","MALE",{"count":296,"type":21},50,"In the UK over 22,000 people undergo pelvic radiotherapy treatment per year, for several types of cancers including prostate cancer. The investigators want to investigate whether there are any differences in the bacteria in the bowel in patients with prostate cancer and whether these change during treatment.\n\nThe aim of this study is to analyse the bacteria from the stool of patients undergoing radiotherapy for prostate cancer. The investigators will also look for any changes in the urine, blood and using rectal swabs that might be a surrogate for what is happening in the gut at the same time. They will collect food frequency\u002F food diary information for each patient alongside health questionnaires.\n\nThe investigators aim to recruit approximately 50 patients diagnosed with prostate cancer due to undergo radiotherapy over a two year period. Patients will be recruited across 2 sites (Rosemere Cancer Centre, Lancashire Teaching Hospitals Trust and The Christie NHS Foundation Trust).",[299],"Prostate Cancer",[301],"radiotherapy",{"date":303,"type":36},"2024-12-20",{"date":305,"type":36},"2024-11-19",{"date":307,"type":21},"2027-07",{"name":42,"class":43},2,{"id":311,"slug":312,"hasResults":11,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":316,"eligibilityCriteria":317,"healthyVolunteers":11,"sex":17,"minAge":160,"maxAge":318,"enrollmentInfo":319,"targetDuration":4,"studyType":22,"phases":321,"briefSummary":322,"conditions":323,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":44},"100525587","introduction-of-y90-pet-ct-post-radioembolisation-therapy-scans-100525587","NCT06123676","Introduction of Y90-PET-CT Post Radioembolisation Therapy Scans","Introduction to the Clinical Workflow of Y90-PET-CT Post-therapy Scans to Patients Undergoing Y90-microspheres Radioembolisation Therapy","Y90-PET-CT","Inclusion Criteria:\n\n* Patients undergoing liver treatment Y90-Microspheres therapy.\n* Male or female\n* Aged 18-85 years\n\nExclusion Criteria:\n\nA participant will not be eligible for inclusion in this study if any of the following criteria apply:\n\n* History of, or suffers from, claustrophobia or participant feels unable to lie flat and still on their back for a period of up to 45 minutes in the scanner;\n\n  o Priority will be given to their current clinical care scan Y-90-bremsstrahlung-SPECT\n* In the opinion of the clinical team, they are unlikely to comply with the study protocol and restrictions that it imposes (i.e. patient uncomfortable to withstand a double scan on the day); Female participants of childbearing potential must confirm they are not pregnant (a strict requisite before 90Y-therapy anyway).","80 Years",{"count":320,"type":21},10,[24],"Yttrium-90, attached to microspheres, usually referred to as 90Y-microspheres or Y-90 radioembolisation, can be used in some cases to treat patients with liver tumours or liver metastasis. The treatment aim is to infuse the 90Ymicrospheres into the patient's liver. The microspheres get trapped in the lesions of micro-blood vessels while the yttrium-90, a radioactive compound, delivers radiation doses locally at these sites and damages the diseased cells.\n\nTherapy is performed in such a way the 90Y-microspheres are localised in the tumour areas minimising damage to the healthy liver tissue. This treatment requires many steps involving professionals from different medical disciplines.\n\nPatients are scanned in the nuclear Medicine Department on a gamma camera the day after the treatment. This scan is referred as Y-90 bremsstrahlung-SPECT. This posttherapy scan provides a 3-dimensional (3D) image of the distribution of the therapeutic agent in the patient's abdomen so an assessment of how much of the therapeutic agent has gone to the sites of disease can be performed.\n\nIn this research project, the investigators would like to evaluate an alternative post-therapy scan to the one routinely performed on the gamma camera. The alternative scan is done on a PET-CT scanner and is referred to as Y90-PET-CT. This type of scan has been reported to provide improved quality images, providing more accurate information on the distribution of the patients therapeutic dose.\n\nFor this research project, the investigators will invite a small number of patients undergoing this therapy to be scanned twice after treatment: with the current post-therapy scan on a gamma camera; and with the newly proposed scan method, Y90-PET-CT. Depending on the outcomes of this project, assessed by an expert panel of radiologists and medical physicists, the investigators will determine whether we will introduce this new scanning method into clinical practice in the future.",[62],"2024-11-04",{"date":326,"type":36},"2024-11-05",{"date":328,"type":36},"2023-10-09",{"date":330,"type":21},"2026-05",{"name":42,"class":43},{"id":333,"slug":334,"hasResults":11,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":338,"eligibilityCriteria":339,"healthyVolunteers":11,"sex":17,"minAge":160,"maxAge":4,"enrollmentInfo":340,"targetDuration":4,"studyType":22,"phases":342,"briefSummary":343,"conditions":344,"keywords":346,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":4},"100548488","investigating-the-role-of-adjuvant-proton-beam-therapy-in-patients-with-parotid-carcinoma-100548488","NCT06421649","Investigating the Role of Adjuvant Proton Beam Therapy in Patients With Parotid Carcinoma","An Evaluative Commissioning Study to Investigate the Role of Adjuvant Proton Beam Radiotherapy in Patients With Localised Parotid Carcinoma","PRONTO","Inclusion Criteria:\n\n1. ≥ 18 years old.\n2. Histologically confirmed primary malignant tumours of parotid gland.\n3. Requiring post-operative radiotherapy to the parotid bed, with a dose equivalent of at least 60 Gray (Gy) in 2 Gy \u002F fraction.\n4. Treatment delivered with radical intent.\n5. All patients must be suitable to attend regular follow-up, audiograms, toxicity monitoring, and be available for long term follow-up.\n6. Willingness to comply with the protocol, including travel to the proton centre for Intensity Modulated Proton Therapy (IMPT) treatment.\n7. Written informed consent.\n\nExclusion Criteria:\n\n1. Previous radiotherapy to the head and neck region;\n2. Parotid tumours requiring primary radiation or those with gross residual disease;\n3. Metastases from squamous cell carcinoma of the head and neck to the parotid gland;\n4. Benign tumours requiring post operative radiotherapy;\n5. Previous or concurrent illness, which in the investigators opinion would interfere with either completion of therapy or follow-up;\n6. Patients requiring or receiving neoadjuvant, concomitant or planned adjuvant chemotherapy.\n7. Patients who are eligible for PBT under routine commissioning",{"count":341,"type":21},97,[24],"Proton Beam Therapy (PBT) is an advanced radiotherapy technique. There are two National Health Service (NHS) PBT treatment centres in the UK, one in Manchester and one in London. The NHS is committed to ensuring the best use of this limited resource by investigating which patients will benefit from PBT treatment.\n\nEvaluative Commissioning in Protons (ECIP) is a programme of studies that explore the role of PBT for patients with different types of cancer. They are funded by NHS England. ECIP studies are not randomised studies, which means that all eligible patients will be offered proton therapy. Any patient in the United Kingdom (UK) can be referred, and for patients that need to travel far to their nearest centre, accommodation will be available.\n\nThe main benefit of PBT, compared with photon radiotherapy, is the predicted reduction in radiation dose to surrounding healthy tissues. With photon radiotherapy, some radiation passes beyond the target area, affecting healthy tissues and causing side-effects. With PBT, the radiation dose stops within the target area, causing less damage to surrounding tissues, and limiting side effects.\n\nPRONTO is a study within the ECIP programme exploring whether PBT can reduce treatment side effects for patients with salivary gland cancers who need radiotherapy following surgery. Whilst radiotherapy is associated with good cancer control, it commonly causes problematic side-effects such as loss of taste and dry mouth. These can be permanent and can negatively affect someone's quality of life. PRONTO's main aim is to see if PBT can reduce the loss of taste following radiotherapy.\n\nParticipants in PRONTO will be closely monitored by the medical team and with questionnaires. The patient experience will be compared to what we would expect with standard photon radiotherapy.",[345],"Parotid Cancer",[347,348,349],"proton beam therapy","protons","evaluative commissioning","2024-08-20",{"date":352,"type":36},"2024-08-21",{"date":354,"type":21},"2024-11-01",{"date":356,"type":21},"2029-06-01",{"name":42,"class":43},{"id":359,"slug":360,"hasResults":11,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":364,"eligibilityCriteria":365,"healthyVolunteers":11,"sex":17,"minAge":366,"maxAge":4,"enrollmentInfo":367,"targetDuration":4,"studyType":22,"phases":369,"briefSummary":370,"conditions":371,"keywords":373,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":375,"startDateStruct":376,"completionDateStruct":377,"leadSponsor":378,"locationsCount":4},"100549474","evaluation-of-combined-modality-protons-and-hepatic-transplantation-for-hilar-cholangiocarcinoma-100549474","NCT06434493","Evaluation of Combined Modality Protons and Hepatic Transplantation for Hilar Cholangiocarcinoma","Evaluation of Combined Modality Protons and Hepatic Transplantation for Hilar Cholangiocarcinoma (an Evaluative Commissioning in Protons Study)","EMPHATIC","Inclusion Criteria:\n\nGeneral criteria\n\n* Age 17 years and over\n* Performance status 0 or 1 (Eastern Cooperative Oncology Group)\n* Suitable for liver transplantation as determined by Multi Disciplinary Team (MDT)\n* Able to tolerate neoadjuvant therapy.\n* A history of primary sclerosing cholangitis (PSC) will be a necessary eligibility criterion at the start of the study. Part-way through recruitment to the study, the eligibility criteria may be broadened, allowing patients with sporadic \u002F non-PSC unresectable cholangiocarcinoma to also be considered. The decision to do this will be taken by the Study Management Group, who will be monitor results closely, following an interim analysis after the first 10 patients. Suitability for Orthotropic Liver Transplant will continue to be confirmed in the regional Hepato Biliary cancer MDT.\n\nSpecific criteria\n\n* Presence of a dominant hilar stricture or mass \\\u003C3cm on cross-sectional imaging\n* Histologically proven cholangiocarcinoma by brush cytology or biopsy via Endoscopic Retrograde Cholangiopancreatography (ERCP) or Percutaneous Transhepatic Cholangiography (PTC)\n* No metastatic disease, including to regional lymph nodes.\n\nExclusion Criteria:\n\nGeneral criteria\n\n* Inability to consent\n* Poor performance status\n* Failed fitness assessment\n* Extrahepatic disease at any stage of presentation, assessment and treatment\n* Prior biliary resection or hilar dissection for attempted resection within the past 12 months\n* Prior malignancy in the last 5 years (excluding early breast, prostate, cervix and non melanoma skin cancers)\n\nSpecific criteria\n\n* Estimated Glomerular Filtration Rate (eGFR) \\\u003C30\n* Prior radiation to the upper abdomen\n* Uncontrolled infection\n* Duodenal invasion","17 Years",{"count":368,"type":21},30,[24],"Proton Beam Therapy (PBT) is an advanced radiotherapy technique. There are two National Health Service (NHS) PBT treatment centres in the United Kingdom (UK), in Manchester and London. The NHS is committed to ensuring the best use of this limited resource by investigating which patients will benefit from PBT.\n\nEvaluative Commissioning in Protons (ECIP) is a programme of studies exploring the role of PBT in different types of cancer. The studies are funded by NHS England. ECIP studies are not randomised studies, which means that all eligible patients will be offered PBT. Any eligible patient in the UK can be referred, and accommodation is available for patients who don't live close to a PBT centre.\n\nThe main benefit of PBT, compared with standard photon radiotherapy, is the predicted reduction in radiation dose to surrounding healthy tissues. With photon radiotherapy, some radiation passes beyond the target area, affecting healthy tissues and causing side-effects. With PBT, the radiation dose stops within the target area, causing less damage to surrounding tissues, and limiting side effects.\n\nEMPHATIC is a study within the ECIP programme. In EMPHATIC, the investigators are looking to see whether a combination of treatments, including PBT, chemotherapy and a liver transplant, can be used to treat patients with cholangiocarcinoma (bile duct cancer).\n\nEMPHATIC offers patients whose cancer can't be removed with surgery (unresectable) a potentially curative treatment option. There is evidence that liver transplant is a curative treatment option in patients with cholangiocarcinoma. There is a risk that the cancer may grow or spread whilst waiting for a transplant, potentially making patients ineligible. PBT and chemotherapy is thought to be the best way to control the cancer, until a liver transplant can be performed. EMPHATIC will look at how a combination of PBT and chemotherapy, followed by a liver transplant, can be used to curatively treat patients with unresectable cholangiocarcinomas.",[372],"Cholangiocarcinoma",[347,348,349,374],"liver transplant",{"date":352,"type":36},{"date":354,"type":21},{"date":356,"type":21},{"name":42,"class":43},{"id":380,"slug":381,"hasResults":11,"nctId":382,"briefTitle":383,"officialTitle":384,"acronym":385,"eligibilityCriteria":386,"healthyVolunteers":11,"sex":17,"minAge":387,"maxAge":388,"enrollmentInfo":389,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":390,"conditions":391,"keywords":396,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":4},"100553039","exploratory-study-of-ebv-dna-titre-clearance-whilst-on-proton-beam-therapy-100553039","NCT06480903","Exploratory Study of EBV DNA Titre Clearance Whilst on Proton Beam Therapy","Exploratory Study of Plasma Epstein Barr Virus (EBV) DNA Clearance During Proton Beam Therapy (PBT) for Nasopharyngeal Carcinoma (NPC)","ClearED","Inclusion Criteria:\n\n* Children and young adults (8-30 years old)\n* Pathologically confirmed EBV-positive nasopharyngeal carcinoma\n* Stage I-IVA (AJCC 8th Edition)\n* Planned to commence curative-intent radiation therapy\n\nExclusion Criteria:\n\n* Recurrent NPC\n* Concurrent or previously treated EBV-associated malignancy\n* Prior radiation therapy\n* Contraindications to MRI\n* General anaesthetic requirement for MRI","8 Years","30 Years",{"count":320,"type":21},"How does plasma Epstein-Barr Virus (EBV) DNA level change during definitive radiation therapy for nasopharyngeal carcinoma (NPC) in the teenage and young adult cohort and does it correlate with outcomes?",[392,393,394,395],"Nasopharyngeal Carcinoma","Head and Neck Cancer","Nasopharyngeal Cancer","Epstein-Barr Virus",[397],"Nasopharyngeal, cancer, proton beam, epstein-barr virus","2024-06-25",{"date":400,"type":36},"2024-06-28",{"date":402,"type":21},"2024-08-30",{"date":404,"type":21},"2026-08-30",{"name":42,"class":43},{"id":407,"slug":408,"hasResults":11,"nctId":409,"briefTitle":410,"officialTitle":410,"acronym":411,"eligibilityCriteria":412,"healthyVolunteers":11,"sex":17,"minAge":160,"maxAge":4,"enrollmentInfo":413,"targetDuration":4,"studyType":22,"phases":415,"briefSummary":417,"conditions":418,"keywords":420,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":423,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":4},"100552268","phase-2-circulating-tumour-dna-guided-adaptive-braf-and-mek-inhibitor-therapy-100552268","NCT06470880","Circulating Tumour DNA Guided Adaptive BRAF and MEK Inhibitor Therapy","DyNAMIc","Inclusion Criteria\n\nAt Screening\n\n1. Written and informed consent obtained from participant and agreement of participant to comply with the requirements of the study\n2. Histological confirmation of cutaneous melanoma\n3. ≥ 18 years of age\n4. Stage III un-resectable\u002F IV disease\n5. Measurable disease on CT (thorax, abdomen and pelvis, ± neck if indicated) and\u002For PET-CT, and CT or MRI (brain) scan (RECIST v1.1)\n6. BRAF p.V600E\u002FK\u002FR\u002FD mutation confirmed (exact point mutation must be known)\n7. ECOG performance status 0\u002F1\u002F2\n8. Prior radiotherapy or radiosurgery must have been completed at least 2 weeks prior to the first dose of study drugs\n9. Adequate organ function as defined below:\n\n   i. Haemoglobin ≥ 9 g\u002FdL ii. White blood count ≥ 2 x109\u002FL iii. ANCa ≥ 1.2 x109\u002FL iv. Platelet count ≥ 75 x109\u002FL v. Albumin ≥ 2.5 g\u002FdL vi. Total bilirubinb ≤ 1.5 x ULNa vii. ASTa or ALTa ≤ 3 x ULNa viii. Calculated creatinine clearance ≥ 30ml\u002Fmin\n10. Women of childbearing potential participating in the study (WOCBP see Appendix B for definition) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG) within 72 hours prior to the start of study drug.\n11. WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drugs plus at least 28 days following last dose of drug (either encorafenib or binimetinib), (see Appendix B).\n12. Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment plus 90 days (duration of sperm turnover) from last dose of drug (either encorafenib or binimetinib), (see Appendix B).\n\n    At randomisation:\n13. Left Ventricular Ejection fraction (LVEF) ≥ 50% or ≥LLNa by ECHO\n14. BRAF ctDNA TAB level of ≥15 copies\u002Fml of plasma\n\nExclusion Criteria\n\n1. Prior systemic targeted BRAF\u002FMEKi therapy for stage IV (metastatic) melanoma (treatment for stage III allowed as long as RFS ≥26 weeks following discontinuation of drugs)\n2. BRAF wild-type malignant melanoma\n3. Metastasis to the brain or leptomeninges\n4. Any contraindication to treatment with encorafenib or binimetinib as per the local Summary of Product Characteristics\n5. Hypersensitivity to the active substance or to any of the excipients of encorafenib or binimetinib\n6. Current use of a prohibited medication as described in Section 8.9\n7. History of another malignancy. Exception: Patients who have been disease-free for 3 years, (i.e. patients with second malignancies that are indolent or definitively treated at least 3 years ago), curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS); stage 1, grade I endometrial carcinoma, or patients with a history of completely resected non-melanoma skin cancer. No additional therapy should be required whilst the patient is on study\n8. Any serious or unstable pre-existing medical conditions (aside from malignancy exceptions specified above), psychiatric disorders, or other conditions that could interfere with the patient's safety, obtaining informed consent, or compliance with study procedures\n9. Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection\n10. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption\n11. Child Pugh B or C liver disease\n12. Coronary syndromes (including myocardial infarction within 6 months or unstable angina)\n13. A history or evidence of current ≥ Class II congestive heart failure as defined by the NYHA guidelines with an ejection fraction of \\\u003C50% (see appendix C)\n14. Treatment refractory hypertension defined as a blood pressure of systolic \\>150 mmHg and\u002For diastolic \\>95 mm Hg on \\>3 occasions which cannot be controlled by anti-hypertensive therapy\n15. Uncorrectable electrolyte abnormalities \\> CTCAE v5 Grade 1 (e.g. hypokalaemia, hypomagnesaemia, hypocalcaemia), long QT syndrome (baseline 1 QTC interval ≥ 480msec) or taking medicinal products known to prolong the QT interval\n16. A history or current evidence\u002Frisk of retinal vein occlusion (RVO) or central serous retinopathy (CSR) including presence of predisposing factors to RVO or CSR (e.g., uncontrolled glaucoma or ocular hypertension, uncontrolled hypertension, uncontrolled diabetes mellitus, or a history of hyperviscosity or hypercoagulability syndromes)\n17. Females who are pregnant or breast-feeding and are not able to stop breast-feeding prior to first dose of study drugs (see section 7.5)\n18. Prisoners or patients who are involuntarily incarcerated\n19. Patients who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness",{"count":414,"type":21},40,[416],"PHASE2","The goal of this clinical trial is to investigate adaptive therapy in late-stage cutaneous melanoma. The main question it aims to answer are:\n\nIf the patient having breaks in their treatment allows the less resistant cells to continue to grow, this would result in a tumour with a lower proportion of resistant cells, making the tumour less resistant to the treatment, an increasing the time it takes for the disease to progress?\n\nParticipants will\n\n* Receive their allocated treatment regimen until their cancer progresses, they or their doctor withdraw them from the study, or until the study ends, whichever happens first.\n* Attend fortnightly visits to hospital.\n* Complete EORTC QLQ-C30 and PRO-CTCAE questionnaires, prior to treatment, every 12 weeks and at the point of cancer progression, to assess quality of life.\n\nResearchers will compare the adaptive therapy participant arm with a standard of care arm to answer the research question described above.",[419],"Melanoma",[421],"Adaptive Therapy","2024-06-17",{"date":424,"type":36},"2024-06-24",{"date":426,"type":21},"2024-06",{"date":428,"type":21},"2027-06",{"name":42,"class":43},{"id":431,"slug":432,"hasResults":11,"nctId":433,"briefTitle":434,"officialTitle":434,"acronym":4,"eligibilityCriteria":435,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":436,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":438,"conditions":439,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":440,"lastUpdatePostDateStruct":441,"startDateStruct":443,"completionDateStruct":445,"leadSponsor":447,"locationsCount":113},"100418023","tumour-characterisation-to-guide-experimental-targeted-therapy---national-100418023","NCT04723316","Tumour Characterisation to Guide Experimental Targeted Therapy - National","Inclusion Criteria:\n\n1. Aged 16 years or over.\n2. Written informed consent according to GCP and national regulations.\n3. Patients with confirmed histological or cytological diagnosis of advanced solid cancer who have been referred to any of the ECMCs in the UK AND considered fit enough to receive an experimental therapeutic agent.\n4. Availability of archival tumour sample (if tumour profiling is required)\n5. Willingness to provide blood samples during the course of the study if allocated to a matched experimental therapy.\n\nExclusion Criteria:\n\n1. Known HIV, Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or Hepatitis C virus (defined as HCV RNA detected), due to the difficulties in handling high-risk specimens. Routine testing for hepatitis is not required. Note: Patients with past\u002Fresolved Hepatitis B infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen \\[anti-HBc\\] antibody test) are eligible. Patients with a history of Hepatitis C infection are eligible only if polymerase chain reaction (PCR) analysis is negative for HCV RNA at least 6 months after completing treatment for Hepatitis C infection.\n2. Known current COVID19 positive (by PCR) or active symptoms for COVID19. Routine testing for COVID19 is not required. Patients with past infection who have fully recovered may be included.\n3. Patients who are unable to provide fully informed written consent.\n4. Patients not considered eligible by the investigator for early phase clinical trials.\n5. Patients currently receiving systemic anti-cancer therapy (due to potential impact on ctDNA analysis), unless patient has clear evidence of progression on hormone-based therapies or tyrosine kinase inhibitors. A minimum of 3 weeks is required post completion of other systemic anti-cancer therapies.\n6. Presence of any medical, psychological, familial or sociological condition that, in the investigator's opinion, will hamper compliance with the study protocol and follow-up schedule.\n7. Bleeding diathesis (patients' on anticoagulation are permitted to enter the trial if anticoagulation can be safely managed to enable fresh tumour biopsies and blood sampling).\n8. Conditions in which research biopsies or blood sampling may increase risk of complications for the patients and\u002For investigator",{"count":437,"type":21},6000,"The primary aim of TARGET National is to establish a national framework to offer molecular profiling of circulating tumour DNA and\u002For tumour tissue (optional) to patients with advanced solid cancers referred to any of the Experimental Cancer Medicine Centres (ECMCs) across the UK, in order to help decision making for allocation to molecularly targeted experimental cancer treatments. Patients will be allocated treatment using a national Molecular Tumour Board to find the most suited therapies based on their molecular profiling results.\n\nThis study aims to recruit up to 6,000 patients with advanced solid tumours across 5 years and proposes to collect blood samples, archival tumour tissue and fresh tissue (optional)\n\nThe data may also be used for future development of predictive cancer biological markers, the design of clinical trials involving new or existing drugs, discovery of new genetic targets and exploring how resistance to specific anticancer agents arises in patients to help improve future cancer treatment management.",[62],"2024-02-06",{"date":442,"type":36},"2024-02-07",{"date":444,"type":36},"2021-06-30",{"date":446,"type":21},"2028-01-30",{"name":42,"class":43},{"id":449,"slug":450,"hasResults":11,"nctId":451,"briefTitle":452,"officialTitle":453,"acronym":4,"eligibilityCriteria":454,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":455,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":457,"conditions":458,"keywords":459,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":463,"startDateStruct":465,"completionDateStruct":467,"leadSponsor":469,"locationsCount":44},"100400399","serial-tumour-biopsies-and-blood-biomarkers-in-melanoma-100400399","NCT04493723","Serial Tumour Biopsies and Blood Biomarkers in Melanoma","Molecular Characterisation of Serial Tumour Samples and Their Correlation With Circulating Biomarkers and Other Biospecimens Taken During the Clinical Course of Patients Receiving Treatment for Malignant Melanoma.","Inclusion Criteria:\n\n1. Age of 16 years or more.\n2. Patients must have given written informed consent.\n3. Evidence of locally advanced or metastatic melanoma, i.e. stage III or IV disease.\n4. Accessible tumour that can be safely biopsied using radiological or surgical techniques (if consenting to part A).\n5. Full blood count and coagulation tests within acceptable parameters (if consenting to part A).\n\nExclusion Criteria:\n\n1. Inability to provide informed consent.\n2. History of significant bleeding disorder (patients on anticoagulation are eligible if the anticoagulation can be safely managed to allow fresh tumour biopsies and blood sampling).\n3. History of HIV, Hepatitis B\u002FC or other transmissible human disease.\n4. Any conditions where research biopsies or blood sampling may increase risk of complications for the patient and\u002For investigator, including high risk groups such as intravenous drug users.",{"count":456,"type":21},300,"Recent advances in understanding how cancer develops and spreads have led to effective new treatments and improved outcomes for patients with melanoma. However, we know that these new treatments do not work for all patients: some do not respond to them and some initially respond but then develop resistance. The overall aim of this study will be to collect tumour biopsies, biomarkers present in the blood, and other biological specimens which can be used to try to understand why resistance to anti-cancer treatment occurs, and to develop predictive biomarkers of this resistance in patients with locally advanced and metastatic malignant melanoma.\n\nThe study will be open to NHS patients aged 16 and over, who have been diagnosed with advanced melanoma, and who will be receiving treatment for their disease as part of their routine care. Patients will be asked to provide samples from tumour biopsies before, during and after treatment. We will also ask for blood samples to look at biomarkers in the blood and see how these correspond with tumour samples, which will further help us to understand treatment response. Biomarkers are substances in the body that can be measured and help indicate how a disease is developing. It is hoped that soon we will be able to monitor cancer by analysing a patient's blood samples, thus reducing the need for biopsies. As blood tests could be taken more frequently, signs that patients are becoming resistant to treatments could be picked up sooner.\n\nAs well as monitoring biomarkers, we would also like to understand what happens to the healthy cells surrounding the tumour during treatment. This will improve our understanding of how cells adapt and respond to treatments, and may eventually lead to the discovery of new biomarkers to help predict which patients will develop resistance to certain treatments.",[419],[460,461],"Tumour Biopsy","Blood Biomarker","2020-07-29",{"date":464,"type":36},"2020-07-30",{"date":466,"type":36},"2018-11-14",{"date":468,"type":21},"2034-07",{"name":42,"class":43},""]