[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neoplasm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neoplasm":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,45,74,105,147,174,202,244,276,306,328,356,374,403,436],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100645124","association-between-4d-mri-parameters-and-the-clinical-characteristics-and-prognosis-of-major-chronic-diseases-100645124",false,"NCT07678606","Association Between 4D MRI Parameters and the Clinical Characteristics and Prognosis of Major Chronic Diseases","4D-MRI","Inclusion Criteria:\n\n* Adults aged 19 years and older undergoing clinically indicated Cardiac MRI at Ulsan University Hospital\n* Participants who undergo an additional 4D MRI sequence during the same imaging session\n* Participants who are able to understand the study and provide written informed consent\n\nExclusion Criteria:\n\n* Individuals aged \\\u003C 19 years\n* Individuals with cognitive impairment or communication difficulties unable to provide informed consent\n* Poor-quality MRI images that are not suitable for analysis\n* Individuals deemed inappropriate for study participation by the investigator",true,"ALL","19 Years",{"count":20,"type":21},1000,"ESTIMATED","10 Years","OBSERVATIONAL","Cancer and cardiovascular diseases are among the leading causes of morbidity and mortality worldwide. Advanced imaging techniques such as 4D magnetic resonance imaging (MRI) enable quantitative assessment of hemodynamic and functional parameters beyond conventional imaging. The aim of this study is to evaluate the association between 4D MRI derived parameters and the occurrence, severity, and prognosis of major chronic diseases, and to explore their potential role as imaging biomarkers.",[26,27,28],"Cardiovascular Disease","Cardiac Magnetic Resonance Imaging","Neoplasm",[30,31,27,32],"Cardiovascular disease","Malignancy","Hemodynamic parameters","NOT_YET_RECRUITING","2026-06-24",{"date":36,"type":37},"2026-07-01","ACTUAL",{"date":36,"type":21},{"date":40,"type":21},"2046-02-28",{"name":42,"class":43},"Ulsan University Hospital","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":44},"100624111","restoring-metabolic-flexibility-through-combined-exercise-in-breast-cancer-survivors-a-randomized-controlled-trial-100624111","NCT07405385","REstoring Metabolic FLEXibility Through Combined Exercise in Breast Cancer Survivors: A Randomized Controlled Trial.","REFLEX","Inclusion Criteria:\n\n* Women aged between 18 and 70 years.\n* Confirmed diagnosis of breast cancer in stages I to III.\n* Received neo-adjuvant or adjuvant chemotherapy and completed the chemotherapy treatment within the 6 months prior to study enrolment.\n* Residency within a distance of less than 40 km from the Hospital Universitario de Toledo.\n\nExclusion Criteria:\n\n* Diagnosis of stage IV breast cancer.\n* Undergone major surgery within the 4 months prior to enrolment or scheduled for breast reconstruction surgery during the study period.\n* Diagnosis of diabetes mellitus with poor glycaemic control, defined as an HbA1c value greater than or equal to 8.5%.\n* Presence of an acute infectious disease.\n* Absolute or relative medical contraindications for physical exercise or maximal exercise stress testing, according to the American College of Sports Medicine (ACSM) guidelines.\n* Serious cardiac or cardiovascular disease, including a history of myocardial infarction, heart failure, or known cardiomyopathy.\n* Regular consumption of beta-blockers or any medication that alters the functioning of the nervous system.\n* Currently active, defined as engaging in more than 150 minutes per week of structured physical exercise during the 6 months prior to enrolment.","FEMALE","18 Years","70 Years",{"count":56,"type":21},44,"INTERVENTIONAL",[59],"NA","The REFLEX study is a randomized, controlled clinical trial designed to evaluate the impact of a 16-week supervised, combined exercise program on metabolic flexibility and cardiorespiratory fitness in breast cancer survivors. While cancer treatments have significantly improved survival rates, the disease and its therapies often cause systemic mitochondrial dysfunction and muscle loss. This leads to persistent \"metabolic inflexibility\"-a reduced ability to efficiently switch between burning carbohydrates and fats for energy. This inflexibility, exacerbated by sedentary behavior and cancer-related fatigue, can severely diminish a patient's functional autonomy and overall quality of life. The trial focuses on assessing whether exercise can restore this metabolic adaptability in women aged 18 to 70 with stage I-III breast cancer who are currently on hormonal treatment and completed neo\u002Fadjuvant chemotherapy within the past 6 months.\n\nThe study operates on the primary hypothesis that an individualized exercise intervention will significantly improve the participants' metabolic flexibility-measured via the metabolic crossover point-and overall aerobic capacity (VO2max) when compared to a control group. Additionally, the trial will analyze secondary outcomes, including changes in cardiovascular and metabolic risk factors, muscle strength, body composition (such as bone mineral density), and patient-reported outcomes assessing quality of life, fatigue, joint pain, anxiety, and depression.\n\nA total of 44 participants will be randomly assigned to either the intervention or control group. Participants in the intervention group will complete a 16-week program consisting of two weekly supervised sessions. Each session lasts between 55 and 85 minutes and includes a tailored combination of aerobic and strength training based on the individual's baseline fitness and metabolic thresholds. Participants in the control group. will receive standard educational materials via email, featuring healthy lifestyle and exercise guidelines from the World Health Organization (WHO) and the American College of Sports Medicine (ACSM).\n\nTo evaluate the program's effectiveness, comprehensive medical and functional assessments will be conducted at baseline, immediately after the 16-week intervention, and at a 3-month follow-up. These evaluations include submaximal and maximal exercise tests on a cycle ergometer to analyze respiratory gases, detailed blood tests, body composition imaging (DXA scans), and maximum dynamic strength testing. Ultimately, the research aims to generate high-quality evidence to optimize standard exercise recommendations for breast cancer survivors and improve their long-term health and resilience.",[62,63,28,64],"Cancer","Breast Cancer","Metabolic Flexibility","2026-05-25",{"date":67,"type":37},"2026-05-28",{"date":69,"type":21},"2026-09",{"date":71,"type":21},"2027-12",{"name":73,"class":43},"University of Castilla-La Mancha",{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":57,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":44},"100636306","phase-1-intratumoral-macrophage-exosomes-with-mechanobiological-reprogramming-for-advanced-solid-tumors-100636306","NCT07563972","Intratumoral Macrophage Exosomes With Mechanobiological Reprogramming for Advanced Solid Tumors","A Phase I, Open-Label, Dose-Escalation Clinical Study to Evaluate the Safety and Tolerability of Intratumoral Administration of Macrophage-Derived Exosomes With Cellular Mechanobiological Reprogramming in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Age 18 to 65 years (inclusive) at screening, any gender.\n2. Histologically or cytologically confirmed advanced (unresectable or metastatic) solid tumors (including melanoma, soft tissue sarcoma, head and neck squamous cell carcinoma, etc.) that have failed standard therapy, have no standard treatment options, or are intolerant to standard treatment.\n3. Must have a primary lesion suitable for local injection, accessible by direct palpation or under ultrasound\u002FCT image guidance.\n4. At least one measurable lesion per RECIST v1.1 criteria.\n5. ECOG performance status score of 0-2.\n6. Expected survival ≥ 3 months.\n7. Adequate organ function within 7 days prior to treatment:\n\n   * Neutrophil count (NEUT#) ≥ 1.5×10\\^9\u002FL; Platelets (PLT) ≥ 80×10\\^9\u002FL; Hemoglobin ≥ 8 g\u002FdL\n   * AST, ALT, ALP ≤ 2.5×ULN; Total bilirubin (TBIL) ≤ 1.5×ULN; Albumin ≥ 2.8 g\u002FdL\n   * Serum creatinine ≤ 1.5×ULN or CCR \\> 60 ml\u002Fmin\n   * INR ≤ 1.5; APTT ≤ 1.5×ULN\n8. Voluntarily participates, signs informed consent, and is able to comply with study visits and procedures.\n\nExclusion Criteria:\n\n1. Contraindications to intratumoral injection: inflammation or ulceration at injection site; severe bleeding tendency; abnormal or permanent body art (e.g., tattoos) at injection site interfering with local reaction observation.\n2. History of other malignancies (except cured basal cell carcinoma, squamous cell carcinoma of skin, superficial bladder cancer, cervical carcinoma in situ, intramucosal gastrointestinal cancer without recurrence for 5 years).\n3. Active autoimmune disease or history of autoimmune disease (including but not limited to immune-related neuropathy, multiple sclerosis, autoimmune neuropathy, Guillain-Barré syndrome, myasthenia gravis, SLE, connective tissue disease, scleroderma, IBD, autoimmune hepatitis, TEN, or Stevens-Johnson syndrome); except Type 1 diabetes on stable insulin dose.\n4. Anti-tumor vaccine within 4 weeks before first dose; live vaccines within 4 weeks before or during the study; major surgery or severe trauma within 4 weeks before first dose.\n5. Prior anti-tumor treatment toxicity not recovered to ≤ CTCAE v5.0 Grade 1.\n6. Serious medical conditions: NYHA Class II or higher heart dysfunction, ischemic heart disease, significant arrhythmia, poorly controlled diabetes (fasting glucose ≥ 10 mmol\u002FL), uncontrolled hypertension (SBP \\> 150 mmHg and\u002For DBP \\> 100 mmHg), LVEF \\\u003C 50%, QTc \\> 450 ms (male) or \\> 470 ms (female).\n7. Active tuberculosis or uncontrolled prior TB infection.\n8. Hyperthyroidism or organic thyroid disease (except hypothyroidism controlled with stable thyroid hormone replacement).\n9. Active infection or unexplained fever within 48 hours before first dose, or systemic antibiotics within 1 week before informed consent.\n10. Active HBV (HBV DNA ≥ 2000 IU\u002Fml or 10\\^4 copies\u002Fml), active HCV (HCV antibody positive and HCV RNA above detection limit), or known HIV positive or AIDS history.\n11. Known neurological or psychiatric disorders (e.g., epilepsy, dementia).\n12. Known history of drug abuse or alcohol abuse within 3 months.\n13. Pregnant or breastfeeding women; participants (or their partners) planning pregnancy or unwilling to use contraception from screening to 6 months after study completion.\n14. Receipt of any investigational drug within 4 weeks before first dose, or concurrent enrollment in another interventional clinical study.\n15. Any other factors judged by the investigator that may affect study completion.","65 Years",{"count":83,"type":21},9,[85],"PHASE1","The goal of this phase I clinical trial is to evaluate the safety and tolerability of intratumoral injection of mechanically reprogrammed macrophage-derived exosomes (MRMEs) in adults aged 18-65 years with advanced solid tumors who have failed, are ineligible for, or are intolerant of standard therapies.",[88,28],"Advanced Solid Tumors",[90,91,92,93,94],"Macrophage","Exosomes","Mechanobiological Reprogramming","Microfluidics","Solid Tumor","RECRUITING","2026-05-06",{"date":98,"type":37},"2026-05-11",{"date":100,"type":21},"2026-05-10",{"date":102,"type":21},"2028-05",{"name":104,"class":43},"West China Hospital",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":57,"phases":115,"briefSummary":116,"conditions":117,"keywords":131,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":146},"100598722","phase-1-a-study-to-evaluate-a-novel-gene-therapy-in-patients-with-relapsed-and-refractory-multiple-myeloma-100598722","NCT07075185","A Study to Evaluate a Novel Gene Therapy in Patients With Relapsed and Refractory Multiple Myeloma","A Phase 1 Study to Evaluate the Safety of KLN-1010, a Novel, In Vivo Gene Therapy to Generate Anti-B Cell Maturation Antigen (Anti-BCMA) Chimeric Antigen Receptor-T Cells (CAR-T) in Patients With Relapsed and Refractory Multiple Myeloma","inMMyCAR","Inclusion Criteria:\n\n* Participants must have relapsed and refractory multiple myeloma (RRMM) with measurable disease\n* Participants must have received at least 3 prior lines of therapy including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and CD38-directed monoclonal antibody\n* Participants must have an Eastern Cooperative Group (ECOG) performance status of 0-1\n* Participants must have acceptable laboratory values as defined by the protocol\n\nExclusion Criteria:\n\n* Participants must not have known central nervous system (CNS) involvement with myeloma\n* Participants cannot have plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, and skin changes) syndrome, or primary light chain amyloidosis\n* Participants cannot have ongoing acute systemic infection requiring antimicrobial therapy\n* Participants cannot require systemic steroids for any condition",{"count":114,"type":21},70,[85],"The goal of this clinical trial is to evaluate the safety, tolerability, and recommended Phase 2 Dose (RP2D) of KLN-1010 in patients with relapsed or refractory multiple myeloma.",[118,119,120,121,28,122,123,124,125,126,127,128,129,130],"Multiple Myeloma in Relapse","Myeloma Multiple","Multiple Myeloma Progression","Neoplasms by Histologic Type","Hemostatic Disorders","Vascular Disorder","Paraproteinemias","Blood Protein Disorders","Hematologic Disease and Disorders","Lymphoproliferative Disorders","Immunoproliferative Disorders","Immune System Disease","Gene Therapy",[132,133,134,135],"in vivo CAR-T","multiple myeloma","gene therapy","BMCA","2026-04-22",{"date":138,"type":37},"2026-04-24",{"date":140,"type":37},"2025-07-16",{"date":142,"type":21},"2042-05",{"name":144,"class":145},"Kelonia Therapeutics, Inc.","INDUSTRY",7,{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":154,"enrollmentInfo":155,"targetDuration":4,"studyType":57,"phases":157,"briefSummary":158,"conditions":159,"keywords":163,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":44},"100627319","emdr-integrative-group-protocol-and-individual-treatment-for-patients-with-cancer-a-pilot-study-100627319","NCT07447089","EMDR Integrative Group Protocol and Individual Treatment for Patients With Cancer: A Pilot Study","Combination of the EMDR Integrative Group Protocol and Individual EMDR Treatment in Patients With Advanced Thyroid Cancer: A Pilot Study","Inclusion Criteria:\n\n* cancer diagnosis\n* PTSD (IES-R \\> 32)\n\nExclusion Criteria:\n\n* receiving specialized trauma therapy\n* receiving current psychiatric pharmacological treatment, unless the dosage has been stable for at least 2 months prior to enrollment","100 Years",{"count":156,"type":21},25,[59],"The main aim of the present process-outcome study is to evaluate the feasibility and the effects of an EMDR-IGTP-OTS group intervention on a sample of people with cancer, by using a process-outcome study design, with repeated measures.",[160,28,161,162],"Thyroid Neoplasms","Post-traumatic Stress Disorder (PTSD)","Psychological Distress",[164,62],"Psychoncology","2026-03-02",{"date":167,"type":37},"2026-03-04",{"date":169,"type":37},"2025-12-05",{"date":171,"type":21},"2026-12-05",{"name":173,"class":43},"Università Cattolica di Milano",{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":57,"phases":183,"briefSummary":184,"conditions":185,"keywords":187,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":201},"100574466","phase-1-a-clinical-trial-to-assess-com503-in-participants-with-advanced-solid-malignancies-100574466","NCT06759649","A Clinical Trial to Assess COM503 in Participants With Advanced Solid Malignancies","A First-in-Human, Phase 1 Dose Escalation and Dose Expansion Trial to Assess the Safety and Tolerability of COM503 as Monotherapy and in Combination Therapy in Participants With Advanced Solid Malignancies","Inclusion Criteria:\n\n* Participants with histologically\u002Fcytologically confirmed advanced recurrent or metastatic solid tumor malignancy\n* Part 1 (dose escalation): Participants must have had disease progression on or following all available standard of care (SOC) therapies known to confer clinical benefit.\n* Part 2 (dose expansion): Participants may be enrolled following disease progression that has progressed after at least 1 available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable or is considered inappropriate; or for whom a clinical trial of an investigational agent is a recognized SOC.\n* Participants must have a solid tumor measurable by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) criteria by investigator assessment\n\nExclusion Criteria:\n\n* History of another malignancy within 2 years prior to the first trial intervention administration (unless the malignancy was treated with curative intent with low risk of recurrence \\[e.g., nonmelanoma skin cancer, histologically confirmed complete excision of carcinoma in situ, or similar\\] which are allowed to enroll).\n* Therapy with Immunosuppressive doses of systemic medications, such as steroids (doses \\>10 mg\u002Fday prednisone or equivalent daily) within 2 weeks before trial intervention administration\n* Have known active central nervous system (CNS) metastases and\u002For leptomeningeal disease (LMD).\n* Active and clinically relevant bacterial, fungal, or viral infection that is not controlled or requires systemic antibiotics, antifungals, or antivirals, respectively.\n* Ascites or pleural effusion that is symptomatic and\u002For requiring drainage within 2 weeks prior to the first trial intervention administration.\n* Have active hepatitis B virus (HBV) or hepatitis C virus (HCV), or participants with human immunodeficiency virus (HIV).\n* Any medical condition that, in the investigator's or sponsor's opinion, poses an undue risk to the participant's participation in the trial.",{"count":182,"type":21},200,[85],"The overall goal of this first-in-human (FIH) clinical trial is to learn about the safety and dosing of COM503 when given alone or in combination with zimberelimab in participants with advanced solid tumors.\n\nThe primary objectives of this study are:\n\n* To assess the safety and tolerability of COM503 as monotherapy and COM503 in combination with zimberelimab in participants with advanced solid tumors.\n* To identify the maximum tolerated dose (MTD) \u002F maximum administered dose (MAD) and\u002For the recommended phase 2 dose (RP2D) of COM503 as monotherapy and in combination with zimberelimab in participants with advanced solid tumors.",[28,186],"Cancer, Malignant Tumors",[188,189,190,191],"first-in-human","oncology","monoclonal antibody","immunotherapy","2026-02-26",{"date":194,"type":37},"2026-02-27",{"date":196,"type":37},"2025-01-07",{"date":198,"type":21},"2027-11-22",{"name":200,"class":145},"Compugen Ltd",11,{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":52,"minAge":53,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":57,"phases":212,"briefSummary":213,"conditions":214,"keywords":218,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":243},"100572929","preoperative-radiation-therapy-and-immediate-breast-reconstruction-100572929","NCT06739655","Preoperative Radiation Therapy and Immediate Breast Reconstruction","Preoperative Radiation Therapy and Immediate Breast Reconstruction, a Phase 3 Randomized Controlled Trial in the Belgian Population","PRADAIIBE","Screening assessments, including review of all study eligibility criteria must be completed before enrolment and randomisation.\n\nInclusion criteria:\n\nIn order to be eligible to participate in this study, a participant must meet all of the following criteria:\n\n1\\. Women ≥18 years with histopathologically confirmed breast cancer who:\n\n1.a. require SSM\u002FNSM for any reason (e.g. extensive disease)\n\n1.b. require postoperative radiation therapy of at least the chest wall\n\n1. c. have a wish for a breast reconstruction\n2. An Eastern Cooperative Oncology Group (ECOG) performance status grade ≤ 2\n3. Participant is able and willing to provide written informed consent, which includes compliance with and ability to undergo all study procedures, and attend the scheduled follow-up visit(s) per protocol.\n\nExclusion criteria:\n\nA potential participant who meets any of the following criteria will be excluded from participation in this study:\n\n1. A previous history of breast cancer or irradiation of the chest wall for any other indication, on the other side (ipsilateral). A bilateral SSM\u002FNSM + reconstruction (e.g. in case of a contralateral prophylactic SSM\u002FNSM), or previous contralateral breast cancer disease\u002Ftreatment, do not fall under this criterium and are thus allowed.\n2. Collagen synthesis disease\n3. Ongoing pregnancy\n4. Actively breastfeeding\n5. Smoking at time of inclusion (a history of smoking is allowed but needs to be registered in the eCRF). No interval between smoking cessation and study inclusion is defined, but the reconstructive surgeon needs to be willing to operate the patient using autologous tissue transfer. This generally translates to a smoking cessation of \\>3months preoperatively.\n6. BMI \\> 35 kg\u002Fm2\n7. cT4d tumour, metastatic disease or any reason making SSM\u002FNSM not indicated",{"count":211,"type":21},180,[59],"The goal of this phase III randomized controlled trial (PRADAIIBE) is to assess if preoperative radiation therapy (Preop-RT) combined with immediate breast reconstruction (IBR) can safely improve both aesthetic and quality of life outcomes in breast cancer patients, compared to the standard of care (SoC) therapy consisting of post-mastectomy radiation therapy (PMRT) and delayed\u002Fimmediate breast reconstruction, in a population of breast cancer patients with an indication of mastectomy and PMRT.\n\nThe following hypotheses and outcomes will be assessed at the primary endpoint of 1 year of follow-up:\n\n* Efficacy: Does Preop-RT+IBR lead to a higher BREAST-Q satisfaction with breasts score (primary endpoint), EQ-5D-5L VAS score , EQ-5D-5L Index score, AIS-Total Aesthetic Score, or a shorter treatment duration compared to SoC?\n* Safety: Does Preop-RT+IBR lead to an increase in adverse events (general or surgical), a lower rate of pathologic Complete Response (pCR), or worse survival outcomes compared to SoC? \\[Note: this study was not powered as a non-inferiority trial, all outcomes will be pooled internationally with parallel studies\\]\n\nEligible and consenting participants will undergo screening and baseline assessments. They will then be randomised between experimental (Preop-RT+IBR) and control (SoC) groups, in a 1:1 stratified variable block size design. Follow-up will take place at 3 months, 1, 2, 5, and 10 years after the last study treatment. At baseline and during each follow-up visit each participant will complete the Breast Q 'satisfaction with breasts' and EQ-5D-5L scales, photographs will be taken. During follow-up pCR will be assessed if applicable, adverse events will be registered, and oncological follow-up will be recorded.",[215,216,217,62,28],"Breast Neoplasms","Breast Carcinoma","Breast Adenocarcinoma",[219,220,221,222,223,224,225,226,227,228,229,230,231,232,233],"Breast cancer","Radiotherapy","PRADA","Breast reconstruction","BreastQ","QoL","Skin Sparing Mastectomy","Mastectomy","Breast surgery","radiation therapy","Preoperative radiation therapy","Preoperative RT","Cosmesis","Breast satisfaction","Immediate Breast Reconstruction","2026-02-02",{"date":236,"type":37},"2026-02-04",{"date":238,"type":37},"2025-02-20",{"date":240,"type":21},"2038-02-20",{"name":242,"class":43},"Cancer Research Antwerp",6,{"id":245,"slug":246,"hasResults":11,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":250,"eligibilityCriteria":251,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":57,"phases":254,"briefSummary":255,"conditions":256,"keywords":261,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":44},"100617148","using-artificial-intelligence-to-guide-fluid-therapy-during-major-cancer-surgery-a-randomized-controlled-trial-100617148","NCT07314853","Using Artificial Intelligence to Guide Fluid Therapy During Major Cancer Surgery: A Randomized Controlled Trial","Fluid Optimization in Cancer Surgery With AI-Assisted Management - FOCUS-AFM Trial","FOCUS-AFM","Inclusion Criteria:\n\n* Age ≥ 18 years\n* American Society of Anesthesiologists (ASA) Physical Status II-IV\n* Undergoing major abdominal oncologic surgery (open or laparoscopic) with an expected duration \\>2 hours\n* Planned invasive arterial pressure monitoring\n* Ability to understand and sign informed consent\n\nExclusion Criteria:\n\n* Significant arrhythmias (e.g., persistent atrial fibrillation)\n* Severe aortic stenosis\n* Emergency surgery\n* Sepsis\n* End-stage renal disease on dialysis\n* Pregnancy\n* Impossibility to cannulate the radial artery\n* Refusal to participate or refusal of data processing consent",{"count":253,"type":21},176,[59],"The goal of this clinical trial is to learn if using artificial intelligence to guide intravenous fluid therapy during major cancer surgery can help keep blood pressure more stable compared with usual care in adult patients undergoing major cancer surgery. The main questions it aims to answer are:\n\n* Does artificial intelligence-guided fluid therapy reduce hypotensive events during surgery?\n* Does this approach improve recovery and reduce complications after major cancer surgery?\n\nResearchers will compare artificial intelligence-guided fluid therapy with standard fluid management to see if the artificial intelligence-guided approach provides better support during surgery.\n\nParticipants will:\n\n* Undergo major cancer surgery under general anesthesia\n* Receive either artificial intelligence-guided fluid management or standard fluid management during surgery\n* Be monitored during and after surgery as part of routine clinical care\n* Be followed after surgery to assess recovery and possible complications",[28,62,257,258,259,260],"Hemodynamic (MAP) Stability","Cancer Surgery","Artificial Intelligence (AI)","Fluid Therapy DURING SURGERY",[262,263,264,265,266],"randomized controlled trial","cancer","fluid balance","fluid therapy","artificial intelligence","2026-01-07",{"date":269,"type":37},"2026-01-09",{"date":271,"type":21},"2026-02",{"date":273,"type":21},"2029-02",{"name":275,"class":43},"National Cancer Institute, Naples",{"id":277,"slug":278,"hasResults":11,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":282,"eligibilityCriteria":283,"healthyVolunteers":16,"sex":17,"minAge":284,"maxAge":285,"enrollmentInfo":286,"targetDuration":4,"studyType":57,"phases":288,"briefSummary":289,"conditions":290,"keywords":291,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":44},"100576229","care-study-cancer-asian-americans-and-relationship-enrichment-100576229","NCT06782581","CARE Study: Cancer, Asian Americans, and Relationship Enrichment","Positive Activities for Asian American Cancer Patients and Caregivers","CARE","Inclusion Criteria for Patients:\n\n1. self-identifies as Asian American or Asian\n2. males or females ages 21-80 years\n3. within 2 years of any cancer diagnosis or stage 4 cancer diagnosis\n4. actively undergoing surgery or systemic therapy (e.g., chemotherapy, radiation, immunotherapy) or within the past 6 months,\n5. able to identify a caregiver (e.g., spouse) who lives in the same household or see at least 3 times per week\n6. able to read, write, and speak English (i.e., English proficient; EP) or Mandarin\u002Fsimplified Chinese.\n\nExclusion Criteria for patients:\n\n1. life expectancy less than 6 months in the opinion of the primary physician\n2. inability to stand or walk on their own or other physical limitations that preclude them from participating (3+ on ECOG performance status),\n3. major thought disorder (e.g., schizophrenia or bipolar \\[patient records or self-disclosure\\]).\n\nInclusion Criteria for Caregivers:\n\n1. identifies as Asian American or Asian,\n2. patient considers them to be caregiver\n3. English proficient or Mandarin Chinese proficient\n4. access to computer\u002Fphone, internet, and web browser.\n\nExclusion Criteria for Caregivers:\n\n1. unwilling or unable to participate in the study for any reason,\n2. under the age of 18.","21 Years","80 Years",{"count":287,"type":21},186,[59],"The overarching goal of the current study is to reduce the burden Asian American patients may feel are on their caregivers by designing and testing the feasibility and efficacy of a positive activity intervention designed to increase a sense of autonomy, competence, and connectedness, each of which have been shown to be associated with psychological benefits according to self-determination theory.",[28],[292,62,293,294,295,296],"Asian American","Patient","Positive Activities","Well-being","Caregiver","2025-12-29",{"date":299,"type":37},"2025-12-31",{"date":301,"type":37},"2024-08-06",{"date":303,"type":21},"2027-02-15",{"name":305,"class":43},"Fox Chase Cancer Center",{"id":307,"slug":308,"hasResults":11,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":312,"eligibilityCriteria":313,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":314,"targetDuration":4,"studyType":57,"phases":316,"briefSummary":317,"conditions":318,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":44},"100591406","evaluation-of-the-impact-of-the-clinical-pharmacist-in-oral-therapies-in-oncology-100591406","NCT06980012","Evaluation of the Impact of the Clinical Pharmacist in Oral Therapies in Oncology.","Evaluation of the Impact of the Clinical Pharmacist in the Initiation and Follow-up of Oral Therapies in Oncology.","Pharmaimpact","Inclusion Criteria:\n\n* Patient suffering from an oncological pathology (excluding hematological malignancies)\n* Initiation of a specific treatment in the context of an oncological pathology: oral therapy treatment taken at home in oncology (which may follow surgery, radiotherapy or other in-patient treatments).\n* Patient who has not yet started treatment or who has started treatment less than 30 days\n* Patient with continuation of oral therapy dispensed in pharmacies\n\nExclusion Criteria:\n\n* Patients suffering from hematological malignancies\n* Patient living in an institution or hospital\n* Patient under treatment for more than 30 days\n* Patient undergoing treatment other than oral therapy (venous or subcutaneous anticancer treatment)\n* Patient whose treatment after initiation is not dispensed in a pharmacy",{"count":315,"type":21},90,[59],"The hospital pharmacist plays a vital role at the time of the patient's first prescription in a healthcare facility, to inform the patient about his or her new therapy and create a link between the hospital and the patient's home pharmacy, so that the patient can continue to receive care at home. It is also essential that the hospital pharmacy and the patient's local pharmacy work together within a reasonable timeframe. This will help improve patient care and treatment follow-up, detect any undesirable effects and optimize their management..\n\nThe aim of this prospective interventional study is to measure the benefits of pharmaceutical monitoring in healthcare institutions at the initiation of oral therapy on patient compliance, side-effect management and adherence, in comparison with patients without this monitoring.\n\nThe primary endpoint is compliance with the Girerd questionnaire.",[28],"2025-08-25",{"date":321,"type":37},"2025-08-26",{"date":323,"type":37},"2024-12-31",{"date":325,"type":21},"2026-09-30",{"name":327,"class":43},"Polyclinique Lyon Nord",{"id":329,"slug":330,"hasResults":11,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":4,"eligibilityCriteria":334,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":335,"targetDuration":4,"studyType":57,"phases":337,"briefSummary":338,"conditions":339,"keywords":341,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":44},"100578587","dream2heal-an-adaptive-stepped-care-intervention-for-chinese-cancer-survivors-with-mild-to-moderate-insomnia-100578587","NCT06813235","Dream2Heal: An Adaptive Stepped-care Intervention for Chinese Cancer Survivors With Mild-to-moderate Insomnia","Dream2Heal: A Pilot Sequential Multiple Assignment Randomized Trial (SMART) of an Adaptive Stepped-care Intervention for Chinese Cancer Survivors With Mild-to-moderate Insomnia","Inclusion Criteria:\n\n* Cantonese- or Mandarin-speaking Chinese patients diagnosed with curable breast, colorectal, or gynaecological cancer\n* Completed treatment (except endocrine therapy) within two years\n* Presenting with Pittsburgh Sleep Quality Index (PSQI) score of 6 to 11 indicating mild-to-moderate sleep disturbance\n\nExclusion Criteria:\n\n* Diagnosis of metastatic cancer\n* Current diagnosis of psychiatric disorder\n* Current diagnosis of another sleep disorder,\n* Have received psychological treatment specifically for sleep disturbance",{"count":336,"type":21},72,[59],"The primary objective of this feasibility study is to assess the feasibility and acceptability, and potential clinical significance of an adaptive stepped-care intervention for improving sleep quality among Chinese cancer patients with mild-to-moderate sleep disturbance, using a sequential multiple assessment randomized controlled trial (SMART) design.",[28,340],"Sleep Disturbance",[342,343,344,345,346],"Sequential multiple assessment randomized controlled trial","sleep disturbance","cancer survivors","insomnia","Survivorship intervention","2025-03-31",{"date":349,"type":37},"2025-04-03",{"date":351,"type":37},"2025-02-01",{"date":353,"type":21},"2027-02-02",{"name":355,"class":43},"The University of Hong Kong",{"id":357,"slug":358,"hasResults":11,"nctId":359,"briefTitle":360,"officialTitle":360,"acronym":4,"eligibilityCriteria":361,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":362,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":364,"conditions":365,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":367,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":44},"100584858","development-of-a-platform-for-the-clinical-implementation-of-precision-oncology-in-the-central-southern-regions-of-italy-coesit-100584858","NCT06894823","Development of a Platform for the Clinical Implementation of Precision Oncology in the Central-Southern Regions of Italy (COESIT)","Inclusion Criteria:\n\n* Cancer patients\n* Patients from the central-southern regions\n\nExclusion Criteria:\n\n\\-",{"count":363,"type":21},16000,"COESIT aims to establish a network of reference laboratories in the central-southern regions of Italy for the genetic and molecular characterization of tumors, with the goal of implementing precision and personalized oncology in clinical practice.",[28],"2025-03-19",{"date":368,"type":37},"2025-03-25",{"date":370,"type":37},"2024-12-10",{"date":372,"type":21},"2028-12",{"name":275,"class":43},{"id":375,"slug":376,"hasResults":11,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":4,"eligibilityCriteria":380,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":381,"targetDuration":4,"studyType":57,"phases":383,"briefSummary":384,"conditions":385,"keywords":386,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":400,"locationsCount":402},"100574090","phase-1-human-adme-study-of-14c-ceralasertib-azd6738-and-absolute-bioavailability-of-ceralasertib-100574090","NCT06754761","Human ADME Study of [14C]-Ceralasertib (AZD6738) and Absolute Bioavailability of Ceralasertib","A Phase I, Open-label Study to Assess the Absolute Bioavailability of Ceralasertib (AZD6738) and Absorption, Distribution, Metabolism, and Excretion (ADME) of [14C]-Ceralasertib in Patients With Non-small Cell Lung Cancer, Ovarian Cancer, or Endometrial Cancer","Inclusion Criteria:\n\n* Participants are eligible to be included in the study only if all of the following criteria apply:\n\nAge\n\n1. Male or female ≥ 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place), at the time of signing the ICF.\n\n   Type of Participant and Disease Characteristics\n2. Sufficient ECOG performance status, life expectancy, and ability to swallow and retain oral medication\n3. Adequate organ and marrow function\n4. Willingness and ability to comply with study and follow-up procedures.\n5. Able and willing to stay in hospital for specified residential periods following administration of Ceralasertib\u002F\\[14C\\]-Ceralasertib\n6. Regular bowel movements\n7. Participants with NSCLC must have appropriately documented NSCLC diagnosis, mutation status, treatment history, and disease status according to protocol-specified eligibility criteria\n8. Participants with Ovarian cancer must have appropriately documented ovarian cancer diagnosis, mutation status, treatment history, and disease status according to protocol-specified eligibility criteria 9. Participants with Endometrial cancer must have appropriately documented endometrial cancer diagnosis, treatment history, and disease status according to protocol-specified eligibility criteria 10. Sex and Contraceptive\u002FBarrier Requirements: Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies 11. Informed Consent: patient must be capable of giving signed informed consent as described in Appendix A which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.\n\nExclusion Criteria:\n\n* Participants are excluded from the study if any of the following criteria apply:\n\n  1. History of Diagnosis of protocol-specified medical conditions\n  2. Spinal cord compression or brain metastasis prior to start of study intervention unless asymptomatic and stable\n  3. Persistent toxicities (CTCAE Grade ≥ 2), with the exception of alopecia and vitiligo, caused by previous anticancer therapy.\n  4. History of allogenic organ transplant or autoimmune or inflammatory disorders requiring use of immunosuppressive medications with some protocol specified conditions\u002Fexceptions\n  5. Any medical or surgical condition that would preclude adequate absorption of Ceralasertib\n  6. Inadequate cardiac function \u002F status or other cardiovascular diseases\n  7. Participants with active infection requiring systemic antibiotics, antifungal or antiviral drugs\n  8. Any evidence of severe or uncontrolled systemic disease, as judged by the investigator that would make it undesirable for the participant to participate in the study or would jeopardise compliance with the protocol\n  9. Protocol-specified prior\u002Fconcomitant therapy exclusions\n  10. Protocol-specified prior\u002Fconcurrent clinical study experience\n  11. Other Exclusions including but not limited to tobacco\u002Fnicotine and\u002For alcohol use, or drug\u002Falcohol abuse history\n  12. Not currently pregnant, breast-feeding, or planning to become pregnant",{"count":382,"type":21},8,[85],"This is an open-label, two-part study in participants with NSCLC, ovarian cancer, or endometrial cancer and will be conducted at multiple study sites.\n\nParticipants will be assessed for study eligibility prior to admission to the study site.\n\nPart A will assess the absolute bioavailability, determine the excretory routes of \\[14C\\]-Ceralasertib, and evaluate the PK parameters of a Ceralasertib oral dose and a radiolabelled IV microdose of \\[14C\\]-Ceralasertib.\n\nParticipants will be admitted to the study site pre-dose Part A and will remain at the study site for excreta (urine and faeces) collections, PK sampling and safety assessments. A washout period days will be observed between dosing in Part A and Part B. Part B will assess the ADME of \\[14C\\]-Ceralasertib.\n\nParticipants will be readmitted to the study site for Part B and will remain at the study site for excreta (urine, faeces, and any vomitus) collections, PK sampling, and safety assessments.\n\nParticipants will return to the study site for a Follow-up Visit after the last dose of Ceralasertib which will include routine safety assessments.\n\nAfter the completion of Parts A and B, and following the Follow-up Visit, participants may be allowed further access to Ceralasertib if in the opinion of the investigator and medical monitor they may derive clinical benefit.",[28],[387,388,389,390,391,392],"non-small cell lung cancer","ovarian cancer","endometrial cancer","hADME, bioavailability","AZD6738","ceralasertib","2024-12-23",{"date":395,"type":37},"2025-01-01",{"date":397,"type":21},"2025-01-17",{"date":399,"type":21},"2025-08-08",{"name":401,"class":145},"AstraZeneca",2,{"id":404,"slug":405,"hasResults":11,"nctId":406,"briefTitle":407,"officialTitle":408,"acronym":409,"eligibilityCriteria":410,"healthyVolunteers":16,"sex":17,"minAge":53,"maxAge":81,"enrollmentInfo":411,"targetDuration":4,"studyType":57,"phases":413,"briefSummary":416,"conditions":417,"keywords":418,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":427,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":433,"locationsCount":435},"100567799","phase-2-enhancing-successful-return-to-work-of-employees-with-cancer-by-supporting-employers-miles-intervention-100567799","NCT06672887","Enhancing Successful Return to Work of Employees With Cancer, by Supporting Employers (MiLES Intervention)","Effectiveness, Cost-effectiveness, and Return on Investment of the Web-based MiLES Intervention Targeted at Employers, to Enhance Successful Return to Work of Employees With Cancer","MiLES","Inclusion criteria employees with cancer:\n\n* Diagnosed with cancer \\<2 years earlier;\n* Being of working age (between 18-65 years, considering the Dutch retirement age of 67 years, and the study's follow-up period of one year);\n* In paid employment with an employer;\n* Having either an occupational physician at the involved occupational health service or a reintegration consultant at the involved reintegration service (e.g. working for an organization that is affiliated with one of the settings of this study);\n* Currently fully or partly sick-listed (\\<2 years);\n* Able to understand and read Dutch for filling out questionnaires;\n* Having already informed their employer about their diagnosis of cancer, or intending to do so;\n* Not yet applied or planning to apply for an invalidity benefit under the WIA.\n\nInclusion criteria employers:\n\n* Supports and guides the participating employee with cancer during the period of sick leave and RTW. For example, as the direct supervisor or HR-manager;\n* Able to understand and read Dutch to be able to use the MiLES intervention and for filling out questionnaires;\n* Not yet familiar with the MiLES intervention.\n\nExclusion Criteria:\n\n\\- Employees with cancer and their employers must participate as a dyad. If one party in the dyad is unable or unwilling to participate, the other party cannot participate either.",{"count":412,"type":21},140,[414,415],"PHASE2","PHASE3","The objective of this randomized controlled trial (RCT) is to evaluate the effectiveness of the MiLES intervention targeted at employers, on successful return to work (RTW) of employees with cancer, compared to care as usual (CAU).\n\nSecundary objectives are:\n\n* To evaluate the cost-effectiveness and return-on-investment of the MiLES intervention on successful RTW and quality of life, compared to CAU.\n* To evaluate the effectiveness of the MiLES intervention on several outcome measures on the level of the employee with cancer (time to RTW, quality of life, quality of working life, received work-related support, and satisfaction with work-related support), and the level of the employer (self-efficacy in providing RTW support, and satisfaction with the RTW process).\n\nParticipants will be 140 employer-employee with cancer dyads. All dyads will randomly be allocated to the intervention group, of which the employer will get unlimited access to the MiLES intervention, or to the control group in which CAU will be provided. The follow-up of this study will be 12 months.\n\nAlong with the RCT, a process evaluation using the UK Medical Research Council framework will also be conducted.",[62,28],[419,420,421,422,423,424,425],"Cancer survivor","Employee with cancer","Employer","Return to work","Employment","Manager","Employee","2024-11-01",{"date":428,"type":37},"2024-11-04",{"date":430,"type":37},"2023-12-18",{"date":432,"type":21},"2025-12",{"name":434,"class":43},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)",5,{"id":437,"slug":438,"hasResults":11,"nctId":439,"briefTitle":440,"officialTitle":441,"acronym":442,"eligibilityCriteria":443,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":444,"targetDuration":4,"studyType":57,"phases":446,"briefSummary":447,"conditions":448,"keywords":451,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":465,"locationsCount":467},"100280040","phase-2-the-drug-rediscovery-protocol-drup-trial-100280040","NCT02925234","The Drug Rediscovery Protocol (DRUP Trial)","A Dutch National Study on Behalf of the CPCT to Facilitate Patient Access to Commercially Available, Targeted Anti-cancer Drugs to Determine the Potential Efficacy in Treatment of Advanced Cancers With a Known Molecular Profile","DRUP","Inclusion Criteria:\n\n1. Adult (age \\>18 years) patient with a histologically-proven locally advanced or metastatic solid tumor, multiple myeloma or B cell non-Hodgkin lymphomawith symptomatic disease progression or progression according to RECIST-criteria after standard anti-cancer treatment or for whom no such treatment is available or indicated.\n\n   \\* For patients with a primary brain tumor: Histologically confirmed recurrent or de novo primary brain tumor, with unequivocal progression after prior therapy, at least 3 months after radiotherapy (either first line chemo-radiotherapy or re-irradiation), and with stable or decreasing dosage of steroids for at least 7 days prior to the baseline MRI scan.\n2. ECOG performance status 0-2\n3. Patients must have acceptable organ function as defined below. However, specific inclusion\u002Fexclusion criteria specified in the drug-specific study manual will take precedence:\n\n   1. Absolute neutrophil count ≥ 1.5 x 109\u002Fl\n   2. Hemoglobin \\> 5.6 mmol\u002Fl\n   3. Platelets \\> 75 x 109\u002Fl\n   4. Total bilirubin \\\u003C 2 x ULN\n   5. AST (SGOT) and ALT (SGPT) \\\u003C 2.5 x institutional ULN (or \\\u003C 5 x ULN in patients with known hepatic metastases)\n   6. Serum creatinine ≤ 1.5 × ULN or calculated or measured creatinine clearance ≥ 50 mL\u002Fmin\u002F1.73 m2\n4. Patients must have objectively measurable disease (by physical or radiographic examination, according to RECIST v1.1 for patients with solid tumors, or according to IMWG, Lugano, RANO or GCIG criteria, resp., for patients with multiple myeloma, non-Hodgkin lymphoma, glioblastoma or ovarian cancer in case of CA125-based evaluation (please refer to appendices for further details).\n5. Results must be available from a tumor genomic or protein expression test. Eligible tests may include any of the following technologies: fluorescence in situ hybridization (FISH), polymerase chain reaction (PCR), comparative genomic hybridization (CGH), next generation sequencing (NGS) or immunohistochemistry (IHC). The test may have been performed on the primary tumor or a metastatic deposit, in a diagnostic laboratory or within the context of another CPCT study, and must reveal a potentially actionable variant as defined in Section 5. The test results (full pathology or molecular diagnostics report) must be uploaded in the eCRF.\n6. Patients must have a tumor profile for which treatment with one of the FDA and \u002F or EMA approved (or under revision for approval) targeted anti-cancer drugs included in this study has potential clinical benefit based on preclinical data or clinical information (see section 5).\n7. new (obtained ≤2 months before inclusion, and without any type of anti-cancer therapy within those ≤2 months) fresh frozen tumor biopsy specimen for extensive biomarker testing is mandatory before the start of treatment with a targeted agent included in the protocol. Alternatively, fresh frozen tumor tissue acquired in the context of a standard care procedure may be used, provided that no systemic anti-cancer treatment was given between the procedure and start of study treatment within DRUP.\n\n   The following exceptions are made:\n\n   a. An exception is made for patients with a primary brain tumor, only if the mandatory DRUP pre-treatment biopsy for biomarker analysis cannot safely be obtained:\n   1. The fresh frozen tumor biopsy sample may be replaced by fresh frozen tumor tissue, obtained earlier from recurrent disease, as part of standard of care surgical procedure (i.e., performed at progression)\n   2. If no fresh frozen tumor tissue is available for NGS, and the risk of obtaining a new tumor biopsy is considered too high, no biopsy will be required. In this case, the study coordinators must be informed in advance, and there will be no reimbursement for the biopsy procedure.\n\n   b. In case WGS is performed on tumor tissue outside the context of a clinical trial before inclusion, and without any type of anti-cancer therapy between the collection of tissue and inclusion in DRUP, this can replace the DRUP pre-treatment biopsy, provided that the patient gives consent to use his\u002Fher WGS data for biomarker analysis in DRUP.\n\n   c. An exception is made for patients that underwent an allogeneic hematopoietic stem cell transplantation prior to study enrollment, since this will prevent a correct WGS analysis due to a mismatch between the biopsy specimen and the required blood sample.\n8. Ability to understand and the willingness to sign a written informed consent document.\n9. For orally administered drugs, the patient must be able to swallow and tolerate oral medication and must have no known malabsorption syndrome.\n10. Because of the risks of drug treatment to the developing foetus, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation, and for four months following completion of study therapy. Male patients should avoid impregnating a female partner. Male patients, even if surgically sterilized, (i.e. post-vasectomy) must agree to one of the following: practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, or completely abstain from sexual intercourse.\n\nExclusion Criteria:\n\n1. Ongoing toxicity \\> grade 2, other than alopecia.\n2. Patient is receiving any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement). Required wash out period prior to starting study treatment is at least two weeks. An exception is made for:\n\n   * Patients suffering from CRPC are allowed to continue androgen deprivation therapy.\n   * Medications that are prescribed for supportive care but may potentially have an anti-cancer effect (e.g., megestrol acetate, bisphosphonates). These medications must have been started ≥ 1 week prior to enrollment on this study.\n3. Patient is pregnant or nursing.\n4. Patients with known active progressive brain metastases. Patients with previously treated brain metastases are eligible, provided that the patient has not experienced a seizure or had a clinically significant change in neurological status within the 3 months prior to registration. All patients with previously treated brain metastases must be stable for at least 1 month after completion of treatment and off steroid treatment prior to study enrollment.\n\n   \\* Additional exclusion criteria specific for glioblastoma patients:\n   1. Patients who require anti-convulsant therapy must be taking non-enzyme inducing antiepileptic drugs (non-EIAED). EIAED are prohibited. Patients previously on EIAED must be switched to non-EIAED at least 2 weeks prior to randomization.\n   2. No radiotherapy within the three months prior to the diagnosis of progression.\n   3. No radiotherapy with a dose over 65 Gy, stereotactic radiosurgery or brachytherapy unless the recurrence is histologically proven.\n5. Patients with clinically significant preexisting cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias, or symptomatic congestive heart failure are not eligible.\n6. Patients with known left ventricular ejection fraction (LVEF) \\\u003C 40% are not eligible\n7. Patients with stroke (including TIA) or acute myocardial infarction within 3 months before the first dose of study treatment are not eligible\n8. Patients with any other clinically significant medical condition which, in the opinion of the treating physician, makes it undesirable for the patient to participate in the study or which could jeopardize compliance with study requirements including, but not limited to: ongoing or active infection, significant uncontrolled hypertension, or severe psychiatric illness\u002Fsocial situations.\n\nFor each drug included in this protocol, specific inclusion and exclusion criteria (based on the Package Insert or manufacturers recommendations) may also apply. These can be found in the supplemental information about each agent included in the drug-specific study manuals. Drug-specific inclusion and exclusion criteria will take precedence over the inclusion\u002Fexclusion criteria listed above.",{"count":445,"type":21},1550,[414],"This is a prospective, non-randomized clinical trial that aims to describe the efficacy and toxicity of commercially available, targeted anticancer drugs\\* prescribed for treatment of patients with advanced cancer with a potentially actionable variant as revealed by a genomic or protein expression test. The study also aims to simplify patient access to approved targeted therapies that are contributed to the program by collaborating pharmaceutical companies and to perform next generation sequencing on tumor biopsies for biomarker analyses. Eligible patients have an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma for which standard treatment options are no longer available and acceptable performance status and organ function. A genomic or protein expression test must have been performed on the tumor and the results must identify at least one potentially actionable molecular variant as defined in the protocol. Results from the molecular profiling test will be used to determine an appropriate drug(s) from among those available in the protocol. The choice of drug will be supported by a list of potential profiles, a molecular tumor board, a knowledge library and by study coordinators for review and approval of the match. The protocol-specified treatment will be administered to the patient once any drug-specific eligibility criteria are confirmed and a fresh pre-treatment biopsy is performed for future genetic studies. All patients who receive treatment with a drug available in the protocol will be followed for standard efficacy outcomes including tumor response, progression-free and overall survival as well as duration of treatment. In addition, treatment related toxicity will be evaluated.",[62,449,28,450],"Tumors","Neoplasia",[452,453,454,455,456,457,458],"Molecular tumor profile","Multidisciplinary tumor board","Antitumor drugs","Molecular Targeted Therapy","Drug Repositioning","Off-Label Use","Sequence Analysis, DNA","2024-01-22",{"date":461,"type":37},"2024-01-24",{"date":463,"type":37},"2016-08",{"date":71,"type":21},{"name":466,"class":43},"The Netherlands Cancer Institute",36]