[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"malignancy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:malignancy":23},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,37,70,94,124,166,221,250,271,297,323,344,379,405,431,459],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":4,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":25,"lastUpdatePostDateStruct":26,"startDateStruct":29,"completionDateStruct":31,"leadSponsor":33,"locationsCount":36},"100381092","collection-of-research-data-and-samples-from-patients-who-experience-immunotherapy-side-effects-100381092",false,"NCT04242095","Collection of Research Data and Samples From Patients Who Experience Immunotherapy Side Effects","Establishment of a National Biorepository to Advance Studies of Immune-Related Adverse Events","Inclusion Criteria:\n\n* Received a regimen containing one or more immuno-oncology therapeutics\n* Must have experienced one or more of the following:\n\n  * One or more serious (Grade 3-4) AEs that are likely immune-related\n  * One or more Grade 2 dermatologic or rheumatologic AEs that are likely immune-related\n  * Diagnosis of a rare infection, e.g., fungal or mycobacterial, after starting IO treatment\n\n    \\*\\* Note: Diagnosis of SARS-CoV-2 (COVID-19) is excluded\n  * Hyperprogression. Image submission for patients experiencing hyperprogression is required. For assistance in determining hyperprogression for purposes of eligibility, institutions may contact the study chair and submit images for central review\n  * Has not previously been registered to this study","ALL",{"count":18,"type":19},240,"ESTIMATED","OBSERVATIONAL","This trial collects research data and samples from patients who experience immunotherapy side effects to store for use in future research studies. Studying research data and samples from patients who experience immunotherapy side effects may help researchers better understand how to predict, prevent, and treat these side effects.",[23],"Malignancy","RECRUITING","2026-07-01",{"date":27,"type":28},"2026-07-02","ACTUAL",{"date":30,"type":28},"2020-03-12",{"date":32,"type":19},"2026-10-01",{"name":34,"class":35},"Alliance for Clinical Trials in Oncology","OTHER",625,{"id":38,"slug":39,"hasResults":11,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":4,"eligibilityCriteria":43,"healthyVolunteers":11,"sex":16,"minAge":44,"maxAge":4,"enrollmentInfo":45,"targetDuration":4,"studyType":47,"phases":48,"briefSummary":50,"conditions":51,"keywords":55,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":67,"locationsCount":69},"100643432","sedation-methods-in-percutaneous-transhepatic-biliary-drainage-procedure-quality-and-recovery-100643432","NCT07640243","Sedation Methods in Percutaneous Transhepatic Biliary Drainage: Procedure Quality and Recovery","Evaluation of Sedation Methods Used in Percutaneous Transhepatic Biliary Drainage Procedures in Terms of Procedure Quality, Recovery Time, and Side Effects","Inclusion Criteria:\n\n* Scheduled for elective percutaneous transhepatic biliary drainage (PTBD) and\u002For biliary stenting\n* ASA physical status II-IV\n* Fasting time of at least 6 hours prior to the procedure\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Inability to provide informed consent or to complete study assessments (e.g., Ramsay Sedation Scale, FRAIL scale, Numeric Rating Scale)\n* Clinical diagnosis of Alzheimer's Disease\n* Clinical diagnosis of demantia\n* Known allergy or hypersensitivity to propofol, remifentanil, ketamine, ondansetron, or deksketoprofen\n* Grade 3-4 aortic, mitral, or tricuspid valve disease\n* Advanced or decompensated heart failure (ejection fraction \\\u003C25%)\n* Emergency procedures\n* Refusal to participate in the study","18 Years",{"count":46,"type":19},98,"INTERVENTIONAL",[49],"NA","This prospective, randomized, single-center study aims to evaluate and compare two different sedation and analgesia regimens used during percutaneous transhepatic biliary drainage (PTBD) procedures. A total of 96 adult patients undergoing elective PTBD or biliary stenting will be randomized to receive either propofol-remifentanil or propofol-ketamine sedation. The primary outcome is recovery time assessed using the Modified Aldrete Score. Secondary outcomes include procedure quality, pain scores, patient and operator satisfaction, hemodynamic stability, and the incidence of sedation-related adverse events. The study is designed to determine the optimal sedation strategy for PTBD, particularly in fragile and elderly patient populations.",[52,53,54,23],"Fragility","Biliary Obstruction","Cholangitis",[56,57,58,59,60],"FRAGILITY","Percutaneous Transhepatic Biliary Drainage","SEDATION","KETAMINE","REMİFENTANIL","2026-06-08",{"date":63,"type":28},"2026-06-10",{"date":65,"type":28},"2026-02-01",{"date":63,"type":19},{"name":68,"class":35},"Ankara City Hospital Bilkent",1,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":44,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":47,"phases":79,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":69},"100592926","assessment-of-the-impact-of-increased-production-of-reactive-oxygen-species-produced-during-repeated-sessions-of-hyperbaric-oxygen-therapy-in-patients-undergoing-radiotherapy-for-neoplasia-on-the-occurrence-of-dna-damage-100592926","NCT06999785","Assessment of the Impact of Increased Production of Reactive Oxygen Species Produced During Repeated Sessions of Hyperbaric Oxygen Therapy in Patients Undergoing Radiotherapy for Neoplasia, on the Occurrence of DNA Damage","OXYBAR","Inclusion Criteria:\n\n* Adults (≥18 years old)\n* Having signed an informed consent form\n* Affiliated with or beneficiary of a national health insurance system\n* Admitted to the hyperbaric medicine department for HBOT treatment\n* Either for a complication related to prior radiotherapy (administered for an underlying neoplastic disease), such as:\n\nRadiation cystitis Radiation proctitis \u002F enteritis Radiation dermatitis Mandibular osteoradionecrosis Or for another indication, without any underlying neoplastic disease\n\nExclusion Criteria:\n\n* Patients with a contraindication to hyperbaric oxygen therapy (HBOT)\n* Pregnant, breastfeeding, or postpartum women\n* Patients deprived of liberty by judicial or administrative decision\n* Patients undergoing involuntary psychiatric treatment\n* Patients under legal guardianship or protective custody",{"count":78,"type":19},60,[49],"Hyperbaric Oxygen Therapy (HBOT) is a treatment involving the administration of oxygen at pressures higher than atmospheric pressure, with numerous potential indications such as radiation-induced tissue damage, chronic wounds, and more. HBOT significantly increases the amount of dissolved oxygen in tissues, thereby promoting wound healing.\n\nHowever, this \"hyperoxygenation\" may also exert toxic effects, particularly through the production of reactive oxygen species (ROS), which can induce DNA damage and potentially promote mutagenesis, thereby increasing long-term neoplastic risk.\n\nA single HBOT session is associated with a significant increase in ROS production, which may persist for up to 48 hours post-exposure, and is also linked to DNA damage. DNA repair is typically a rapid process, with the activation of protective mechanisms.\n\nThe effects of repeated HBOT sessions remain a matter of debate. Reported outcomes range from attenuation of genotoxicity, to exacerbation of DNA damage, or no effect at all (8). In patients with cancer or comorbidities associated with impaired DNA repair capacity, repeated HBOT could be more detrimental, potentially increasing genotoxic effects and cancer risk. This increased oxygen susceptibility in cancer patients has already been observed in normobaric conditions during abdominal surgery, where hyperoxygenation strategies were associated with increased mortality in this subgroup.\n\nA potential pro-carcinogenic effect of HBOT in cancer patients has also been suggested in some case series, though not confirmed by larger studies.\n\nCurrent literature on HBOT safety remains generally reassuring; however, the possibility of DNA damage and its potential long-term genotoxic consequences cannot be entirely excluded. This question is of particular importance given that many primary indications for HBOT involve patients with a history of malignancy or active cancer",[82,83,23],"Hyperbaric Oxygen","Genotoxicity","2026-03-31",{"date":86,"type":28},"2026-04-06",{"date":88,"type":28},"2025-07-08",{"date":90,"type":19},"2027-11-15",{"name":92,"class":93},"University Hospital, Angers","OTHER_GOV",{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":44,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":47,"phases":103,"briefSummary":104,"conditions":105,"keywords":108,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":69},"100618929","chest-wall-reconstruction-cohort-100618929","NCT07338006","Chest Wall Reconstruction Cohort","Comparative Outcomes of Chest Wall Reconstruction Using Twisted Steel Wires Versus Bone Cement: A Cohort Study","Inclusion Criteria:\n\n* Patients aged ≥18 years undergoing partial or full-thickness chest wall resection.\n* Defects requiring rigid or semi-rigid reconstruction involving two or more ribs or the sternum.\n\nExclusion Criteria:\n\n* Patients with small defects managed by primary closure or soft tissue-only reconstruction.\n* Patients with concurrent major intrathoracic resections (e.g., pneumonectomy) may confound postoperative respiratory assessment.\n* Recurrent disease requiring revision reconstruction.\n* Patients unwilling or unable to provide consent or comply with follow-up.",{"count":102,"type":19},50,[49],"Chest wall reconstruction following tumor or infection-related resections remains a challenging aspect of thoracic surgery, requiring restoration of structural stability and preservation of respiratory mechanics. While polymethyl methacrylate (PMMA) bone cement has long been used for rigid reconstruction, its limitations-including high cost, rigidity, infection risk, and interference with normal respiratory motion-pose challenges in resource-constrained settings. Twisted stainless steel wires offer a low-cost, flexible alternative that allows dynamic chest wall movement and easier adaptability in low- and middle-income countries such as Pakistan.\n\nTo compare postoperative outcomes, complications, and cost-effectiveness of chest wall reconstruction using twisted stainless steel wires versus PMMA bone cement over a two-year period (January 2025 - December 2026).\n\nThis prospective cohort study was conducted in the Department of Thoracic Surgery, Services Hospital, Lahore, a high-volume tertiary care and referral center. Patients undergoing chest wall reconstruction following resection for tumors, infections, or trauma were enrolled and divided into two groups based on the reconstruction technique used: Group A (twisted steel wires) and Group B (PMMA bone cement). Parameters assessed included postoperative pain (VAS scores), respiratory function, chest wall stability, complications (infection, wound dehiscence, prosthesis exposure), duration of hospital stay, readmission rate, and cost of reconstruction. Data were analyzed to compare clinical and functional outcomes between both cohorts.",[106,107,23],"Chest Wall Tumor","Reconstructive Surgical Procedure",[109,110,111,112,113,114],"Chest wall reconstruction","Bone cement","Stainless steel wire","Thoracic surgery","Postoperative pain","Functional outcomes","2026-01-03",{"date":117,"type":28},"2026-01-13",{"date":119,"type":28},"2021-01-01",{"date":121,"type":19},"2027-03-31",{"name":123,"class":35},"University of Health Sciences Lahore",{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":16,"minAge":44,"maxAge":131,"enrollmentInfo":132,"targetDuration":4,"studyType":47,"phases":134,"briefSummary":135,"conditions":136,"keywords":151,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":69},"100571099","target-specific-immunopet-imaging-of-digestive-system-carcinoma-100571099","NCT06715839","Target-specific immunoPET Imaging of Digestive System Carcinoma","Development and Clinical Translation of immunoPET Imaging Probes for Digestive System Carcinoma","Inclusion Criteria:\n\n1. Aged 18-75 years old and of either sex；\n2. Histologically confirmed diagnosis of digestive system carcinoma or suspected digestive system carcinoma by diagnostic imaging;\n3. Capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol.\n\nExclusion Criteria:\n\n1. Pregnancy；\n2. Severe hepatic and renal insufficiency;\n3. History of serious surgery in the last month;\n4. Allergic to antibody or single-domain antibody radiopharmaceuticals.","75 Years",{"count":133,"type":19},400,[49],"The aim of this study is to establish and optimize the target-specific PET\u002FCT imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agents in digestive system malignant tumors will be evaluated.",[23,137,138,139,140,141,142,143,144,145,146,147,148,149,150],"Digestive Cancer","Digestive System Neoplasm","Digestive System Carcinoma","Digestive System Cancer","Liver Cancer","Stomach Cancer","Colon Cancer","Rectum Cancer","Pancreatic Cancer","Esophagus Cancer","Gallbladder Carcinoma","Small Intestine Cancer","Appendix Cancer","Bile Duct Carcinoma",[152,153,154,155,156],"human epidermal growth factor receptor 2 (HER2)","Trophoblast cell surface antigen 2 (TROP2)","Glypican-3 (GPC3)","Glycoprotein A33 (gpA33)","Nectin cell adhesion molecule-4 (Nectin-4)","2025-12-25",{"date":159,"type":28},"2025-12-31",{"date":161,"type":28},"2024-12-04",{"date":163,"type":19},"2027-09",{"name":165,"class":35},"RenJi Hospital",{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":172,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":16,"minAge":44,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":47,"phases":176,"briefSummary":179,"conditions":180,"keywords":191,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":220},"100592057","phase-2-determine-trial-treatment-arm-06-capmatinib-in-adult-patients-with-cancers-harbouring-met-dysregulations-100592057","NCT06988475","DETERMINE Trial Treatment Arm 06: Capmatinib in Adult Patients With Cancers Harbouring MET Dysregulations","DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial): An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult, Paediatric and Teenage\u002FYoung Adult (TYA) Cancers With Actionable Genomic Alterations, Including Common Cancers With Rare Actionable Alterations. Treatment Arm 06: Capmatinib in Adult Patients With Cancers Harbouring MET Dysregulations","DETERMINE","THE PATIENT MUST FULFIL THE ELIGIBILITY CRITERIA WITHIN THE DETERMINE MASTER PROTOCOL (NCT05722886) AND WITHIN THE TREATMENT ARM 06 (CAPMATINIB) OUTLINED BELOW\\*\n\n\\*When capmatinib-specific inclusion\u002Fexclusion criteria or precautions below differ from those specified in the Master Protocol, the capmatinib-specific criteria will take precedence.\n\nInclusion criteria:\n\nA. Confirmed diagnosis of a MET-positive malignancy using an analytically next-generation sequencing method (METex14 skipping, MET amplification, MET fusion, or MET activating mutation).\n\nB. Adult patients ≥18 years old.\n\nC. Women of childbearing potential are eligible, provided that they meet the following criteria:\n\n* Have a negative serum or urine pregnancy test before enrolment, and\n* Agree to use one form of highly effective birth control method (a method that can achieve a failure rate of \\\u003C1% when used consistently and correctly), such as:\n\nI. combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation \\[oral, intravaginal or transdermal\\])\n\nII. progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable)\n\nIII. intrauterine device (IUD)\n\nIV. Intrauterine hormone-releasing system (IUS)\n\nV. bilateral tubal occlusion\n\nVI. vasectomised partner\n\nVII. sexual abstinence\n\nEffective from the first administration of capmatinib, throughout the trial and for seven days after the last administration of capmatinib.\n\nD. Male patients with partners who are women of childbearing potential are eligible provided that they agree to the following, from first administration of capmatinib, throughout the trial and for seven days after the last administration of capmatinib:\n\n* Agree to take measures not to father children by using a barrier method of contraception (e.g. condom) or sexual abstinence.\n* Non-vasectomised male patients with partners who are women of childbearing potential must also be willing to ensure that their partner uses a highly effective method of contraception, as in criterion C above.\n* Male patients with pregnant or lactating partners must be advised to use barrier method contraception (for example, condom) to prevent drug exposure of the foetus or neonate.\n\nAll male patients must refrain from donating sperm for the same period.\n\nE. Patients must be able and willing to undergo a fresh biopsy at baseline and blood samples for translational research. Note that for patients with haematological malignancies or neuroblastomas, blood, bone marrow aspiration and\u002For trephine or lymph node biopsy samples may be taken.\n\nF. Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility.\n\nExclusion criteria:\n\nA. Diagnosis of NSCLC with METex14 skipping mutation or MET amplification.\n\nB. Prior treatment with a selective MET inhibitor or HGF-targeting therapy unless genetic profile demonstrates a mechanism of resistance known to be potentially sensitive to capmatinib.\n\nC. Carcinomatous meningitis.\n\nD. Presence or history of additional malignant disease that has been diagnosed and\u002For required therapy within the past three years. Exceptions to this exclusion include: completely resected basal cell and squamous cell skin cancers, and completely resected carcinoma in situ of any type.\n\nE. Presence or history of interstitial lung disease (ILD) and\u002For interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention) and evidence of active pneumonitis on screening chest computed tomography (CT) scan. Prior localised radiotherapy related pneumonitis is permitted if resolved and off steroids and asymptomatic for at least six months.\n\nF. Clinically significant, uncontrolled heart disease such as:\n\n* Unstable angina within three months prior to screening\n* Myocardial infarction within three months prior to screening\n* History of documented congestive heart failure (New York Heart Association functional classification III-IV)\n* Uncontrolled hypertension defined by a systolic blood pressure ≥160 mm Hg and\u002For diastolic blood pressure ≥100 mm Hg, with or without antihypertensive medication. Initiation or adjustment of antihypertensive medication(s) is allowed prior to screening.\n\nPatients with a cerebrovascular event (including stroke or transient ischaemic attack \\[TIA\\]) within three months before screening.\n\n• Patients with primary CNS tumours may be considered unless intra-tumoural bleeding has occurred within two weeks of the first dose of capmatinib, and patients with punctate CNS haemorrhages \\\u003C3 mm may be considered.\n\nG. History or current diagnosis of electrocardiogram (ECG) abnormalities indicating significant risk of safety for patients participating in the trial such as:\n\n* Concomitant clinically significant cardiac arrhythmias (atrial and ventricular), e.g., sustained ventricular tachycardia, and clinically significant second or third degree AV block without a pacemaker\n* History of familial long QT syndrome or known family history of Torsades de Pointes\n* Resting QTcF (Corrected QT interval by Fridericia formula) ≥450 msec (male) or ≥460 msec (female) at screening ECG (as a mean of triplicate ECG)\n\nH. Major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) within four weeks prior to starting trial treatment (two weeks for resection of brain lesions) or patients who have not recovered from side effects of such procedure. Video-assisted thoracic surgery (VATS) and mediastinoscopy will not be counted as major surgery and patients can be enrolled in the trial at least one week after the procedure.\n\nI. Patients receiving treatment with strong inducers of cytochrome P450 (CYP) 3A that cannot be discontinued at least one week prior to the start of treatment with capmatinib and for the duration of the trial.\n\nJ. Any clinically significant concomitant disease or condition (or its treatment) that could interfere with the conduct of the trial (including absorption of oral medications) that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this trial.\n\nK. Any impairment of gastrointestinal (GI) function or GI disease that may significantly alter the administration or absorption of capmatinib (e.g., Crohn's disease, ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome or short gut syndrome). Unable to swallow capmatinib intact, without chewing or crushing the tablets (as per the dosing schedule).\n\nL. Active infections including, but not limited to, hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV). Screening for known chronic conditions is not required. Patients with known serological evidence of chronic HBV or HCV infection whose disease is controlled under antiviral therapy according to local regulation are eligible. Patients with history of testing positive for human immunodeficiency virus (HIV) infection are eligible provided the each of the following conditions are met:\n\n* CD4 count ≥350\u002FμL;\n* undetectable viral load;\n* receiving antiretroviral therapy (ART) that does not interact with IMP (patients should be on established ART for at least four weeks); and\n* no HIV\u002F acquired immune deficiency syndrome-associated opportunistic infection in the last 12 months.\n\nM. Known hypersensitivity to any of the excipients of capmatinib.\n\nN. Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the two weeks prior to trial entry to manage CNS symptoms. Primary brain or CNS malignancies are allowed providing the patient is clinically stable (if corticosteroids are required, they must be at a stable or decreasing dose for at least 14 days prior to Cycle 1 Day 1). If patients are on corticosteroids for endocrine deficiencies or tumour-associated symptoms other than CNS related, the dose must have been stabilised (or decreasing) for at least five days before Cycle 1 Day 1.\n\nO. Patients receiving treatment with any enzyme-inducing anticonvulsant that cannot be discontinued at least one week before first dose of capmatinib, and for the duration of the trial. Patients on non-enzyme-inducing anticonvulsants are eligible.\n\nP. Female patients who are pregnant, breastfeeding or planning to become pregnant during the trial or for seven days following their last dose of capmatinib.\n\nQ. Patients who were administered a live, attenuated vaccine within 28 days prior to enrolment, or anticipation of need for such a vaccine during capmatinib treatment or within six months after the final dose of capmatinib.",{"count":175,"type":19},30,[177,178],"PHASE2","PHASE3","This clinical trial is looking at a drug called capmatinib. Capmatinib is approved as standard of care treatment for adult patients with certain types of lung cancer. This means it has gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.\n\nCapmatinib works in patients with lung cancer with a particular mutation in their cancer known as a METex14 skipping mutation.\n\nInvestigators now wish to find out if it will be useful in treating patients with other cancer types which have the same mutation or other specific mutations or changes which take place in the MET gene. If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future.\n\nThis trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.",[181,182,183,184,185,186,23,187,188,189,190],"Solid Tumour","Haematological Malignancy","Malignant Neoplasm","Neoplasms by Histologic Type","Neoplasms by Site","Cancer","Glioma","Neuroblastoma","Gastric Cancer","Soft Tissue Sarcoma",[192,193,194,195,196,197,198,199,200,201,202,203,204,205,184,185,206,207,208,209,210],"adult","capmatinib","MET Tyrosine Kinase Receptor","MET exon 14 skipping","MET amplifications","MET fusions","MET activating mutations","MET dysregulations","Antineoplastic Agents","cancer","malignancy","Malignant Neoplasms","Molecular Targeted Therapy","Mutation","Precision Medicine","Protein Kinase Inhibitors","Rare","Tumour-agnostic","METex14 skipping","2025-11-19",{"date":213,"type":28},"2025-11-24",{"date":215,"type":28},"2024-11-19",{"date":217,"type":19},"2029-10",{"name":219,"class":35},"Cancer Research UK",17,{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":172,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":47,"phases":229,"briefSummary":230,"conditions":231,"keywords":235,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":244,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":248,"locationsCount":249},"100498460","phase-2-determine-trial-treatment-arm-03-entrectinib-in-adult-paediatric-and-teenageyoung-adult-patients-with-ros1-gene-fusion-positive-cancers-100498460","NCT05770544","DETERMINE Trial Treatment Arm 03: Entrectinib in Adult, Paediatric and Teenage\u002FYoung Adult Patients With ROS1 Gene Fusion-Positive Cancers.","DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial): An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult, Paediatric and Teenage\u002FYoung Adult (TYA) Cancers With Actionable Genomic Alterations, Including Common Cancers With Rare Actionable Alterations. Treatment Arm 03: Entrectinib in Adult, Paediatric and Teenage\u002FYoung Adult Patients With ROS1 Gene Fusion-Positive Cancers.","THE PATIENT MUST FULFIL THE ELIGIBILITY CRITERIA WITHIN THE DETERMINE MASTER PROTOCOL (NCT05722886) AND WITHIN THE TREATMENT ARM 03 (ENTRECTINIB) OUTLINED BELOW\\*\n\n\\*When entrectinib-specific inclusion\u002Fexclusion criteria or precautions below differ from those specified in the Master Protocol, the entrectinib-specific criteria will take precedence.\n\nInclusion Criteria:\n\nA. Confirmed diagnosis of a ROS1 gene fusion-positive malignancy, other than NSCLC, that has been identified using an analytically validated next-generation sequencing method.\n\nB. Patients must be able and willing to undergo a fresh tissue biopsy at baseline and blood samples for translational research. Note that for patients with haematological malignancies or neuroblastomas, blood, bone marrow aspiration and\u002For trephine or lymph node biopsy samples may be taken.\n\nC. Patients with a BSA of 0.43m\\^2 and over.\n\nD. ADULT PATIENTS (≥18 years): Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility.\n\nE. PAEDIATRIC PATIENTS (\\\u003C18 years): Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility.\n\nF. Women of childbearing potential are eligible provided that they meet the following criteria:\n\n* Have a negative serum or urine pregnancy test before enrolment and either:\n* Agree to use one form of highly effective birth control method such as:\n\nI. Oral, intravaginal or transdermal combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation\n\nII. Oral, injectable or implantable progestogen-only hormonal contraception associated with inhibition of ovulation\n\nIII. Intrauterine device (IUD)\n\nIV. Intrauterine hormone-releasing system (IUS)\n\nV. Bilateral tubal occlusion\n\nVI. Vasectomised partner\n\nPlus a barrier method if using a hormonal method: male or female condom with or without spermicide; cap, diaphragm or sponge with spermicide OR\n\n• Sexual abstinence;\n\nEffective from the first administration of entrectinib, throughout the trial and for five weeks after the last administration of entrectinib.\n\nG. Male patients with partners who are women of childbearing potential are eligible provided that they agree to the following, from the first administration of entrectinib, throughout the trial and for three months after the last administration of entrectinib:\n\n* Agree to take measures not to father children by using a barrier method of contraception (condom plus spermicide) or to sexual abstinence.\n* Non-vasectomised male patients with partners who are women of childbearing potential must also be willing to ensure that their partner uses a highly effective method of contraception as in F above.\n* Male patients with pregnant or lactating partners must be advised to use barrier method contraception (e.g. condom) to prevent drug exposure of the foetus or neonate.\n\nAll male patients must refrain from donating sperm for the same period.\n\nExclusion Criteria:\n\nA. Female patients who are pregnant, breastfeeding or planning to become pregnant during the trial or within five weeks following their last dose of entrectinib\n\nB. Diagnosis of ROS1 fusion-positive NSCLC\n\nC. Prior treatment with the same class of drug unless genetic profile demonstrates a mechanism of resistance known to be potentially sensitive to entrectinib\n\nD. Patients with significant cardiovascular disease are excluded as defined by:\n\ni. Current congestive heart failure requiring therapy (New York Heart Association III or IV) or known left ventricular ejection fraction (LVEF) \\\u003C50% (moderate to severe).\n\nii. History of unstable angina pectoris or myocardial infarction up to three months prior to trial entry, or current poorly controlled angina (symptoms weekly or more).\n\niii. Presence of symptomatic or severe valvular heart disease (severe by local echo graphic criteria or American Heart Association\u002FAmerican Cardiac College Stage C or D).\n\niv. History of a clinically significant cardiac arrhythmia up to three months prior to trial entry (asymptomatic atrial fibrillation or asymptomatic first-degree heart block are permitted.\n\nv. History of stroke (ischaemic or haemorrhagic) within the last three months.\n\n• Patients with primary CNS tumours may be considered unless intra-tumoural bleeding has occurred within 2 weeks of the first dose of entrectinib, and patients with punctate CNS haemorrhages \\\u003C3 mm may be considered.\n\nE. Patients with a baseline QTcF (Corrected QT interval by Fridericia formula) interval longer than 450 milliseconds (ms) for male patients and 470 ms for female patients, patients with congenital long QTcF syndrome, and patients taking medicinal products that are known to prolong the QTc interval.\n\nF. History of additional risk factors for Torsades de Pointes (e.g., family history of long QT syndrome)\n\nG. Grade ≥2 peripheral neuropathy\n\nH. Known active infections (bacterial, fungal or viral) that would interfere with the assessment of safety or efficacy of entrectinib, including human immunodeficiency virus (HIV) positivity. Patients with history of testing positive for HIV infection are eligible provided the each of the following conditions are met:\n\n* CD4 count ≥350\u002FμL;\n* undetectable viral load;\n* receiving antiretroviral therapy (ART) that does not interact with IMP (patients should be on established ART for at least four weeks); and\n* no HIV\u002F acquired immune deficiency syndrome (AIDS)-associated opportunistic infection in the last 12 months.\n\nI. Known hypersensitivity to entrectinib or any of the excipients\n\nJ. Patients who were administered a live, attenuated vaccine within 28 days prior to enrolment, or anticipation of need for such a vaccine during entrectinib treatment or within six months after the final dose of entrectinib\n\nK. Patient unable to swallow entrectinib intact, without chewing, crushing or opening the capsules (as per the dosing schedule and suitable dosing strengths available). Any active gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would reasonably affect drug absorption\n\nL. Patients with personal history of significant osteopenia (screening for osteopenia not required)\n\nM. Any clinically significant concomitant disease or condition (or its treatment) that could interfere with the conduct of the trial or absorption of oral medications that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this trial",{"count":175,"type":19},[177,178],"This clinical trial is looking at a drug called entrectinib. Entrectinib is approved as standard of care treatment for adult patients with non-small cell lung cancer (NSCLC) which have a particular molecular alteration called ROS1-positive, and patients 12 years old or above with solid tumours which have another type of change in the cancer cells. This means it has gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.\n\nInvestigators now wish to find out if it will be useful in treating patients with other cancer types which have the same molecular alteration (ROS1-positive). If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future.\n\nThis trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.",[182,23,183,232,184,185,186,233,234,187,181],"Lymphoproliferative Disorders","Brain Neoplasms","Melanoma",[236,200,186,237,238,23,203,204,205,239,185,240,241,207,208,242,209,243],"Adult","Child","Entrectinib","Neoplasms by Histologic Site","Oncogene","Paediatric","ROS1 Protein, human","Young adult",{"date":213,"type":28},{"date":246,"type":19},"2025-11-30",{"date":217,"type":19},{"name":219,"class":35},27,{"id":251,"slug":252,"hasResults":11,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":172,"eligibilityCriteria":256,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":257,"targetDuration":4,"studyType":47,"phases":258,"briefSummary":259,"conditions":260,"keywords":264,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":266,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":270,"locationsCount":249},"100498426","phase-2-determine-trial-treatment-arm-02-atezolizumab-in-adult-paediatric-and-teenageyoung-adult-patients-with-cancers-with-high-tumour-mutational-burden-tmb-or-microsatellite-instability-high-msi-high-or-proven-constitutional-mismatch-repair-deficiency-cmmrd-disposition-100498426","NCT05770102","DETERMINE Trial Treatment Arm 02: Atezolizumab in Adult, Paediatric and Teenage\u002FYoung Adult Patients With Cancers With High Tumour Mutational Burden (TMB) or Microsatellite Instability-high (MSI-high) or Proven Constitutional Mismatch Repair Deficiency (CMMRD) Disposition","DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial): An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult, Paediatric and Teenage\u002FYoung Adult (TYA) Cancers With Actionable Genomic Alterations, Including Common Cancers With Rare Actionable Alterations. Treatment Arm 02: Atezolizumab in Adult, Paediatric and Teenage\u002FYoung Adult Patients With Cancers With High TMB or MSI-high or Proven CMMRD Disposition.","THE PATIENT MUST FULFIL THE ELIGIBILITY CRITERIA WITHIN THE DETERMINE MASTER PROTOCOL (NCT05722886) AND WITHIN THE TREATMENT ARM 02 (ATEZOLIZUMAB) OUTLINED BELOW\\*\n\n\\*When atezolizumab-specific inclusion\u002Fexclusion criteria or precautions below differ from those specified in the Master Protocol, the atezolizumab-specific criteria will take precedence.\n\nInclusion Criteria:\n\nA. Confirmed diagnosis of a malignancy that is high TMB (defined as ≥10 mut\u002FMb), MSI-high or of proven (previously diagnosed) CMMRD disposition using an analytically validated next-generation sequencing method. Patient cases with TMB between 10-15 mut\u002FMb may be discussed in an MTB meeting. TMB ≥19 mut\u002FMb will be fast-tracked for an MTB recommendation, unless there are any patient-specific individualities (such as multiple gene amplifications) that require MTB discussion.\n\nB. Women of childbearing potential are eligible provide they meet the following criteria:\n\n* Have a negative serum or urine pregnancy test before enrolment and;\n* Agree to use one form of effective birth control method such as:\n\nI. combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (\\[oral, intravaginal or transdermal\\]);\n\nII. progestogen-only hormonal contraception associated with or without inhibition of ovulation (oral, injectable or implantable);\n\nIII. intrauterine device (IUD),\n\nIV. intrauterine hormone-releasing system (IUS),\n\nV. bilateral tubal occlusion,\n\nVI. vasectomised partner,\n\nVII. sexual abstinence,\n\nVIII. male or female condom with or without spermicide;\n\nIX. cap, diaphragm or sponge with spermicide.\n\nEffective from the first administration of atezolizumab, throughout the trial and for five months after the last administration of atezolizumab.\n\nC. Male patients with partners who are women of childbearing potential are eligible provided that they agree to the following, from the first administration of atezolizumab, throughout the trial until the last administration of atezolizumab:\n\n* Agree to take measures not to father children by using a barrier method of contraception (condom plus spermicide) or sexual abstinence.\n* Non-vasectomised male patients with partners who are women of childbearing potential must also be willing to ensure that their partner uses an effective method of contraception.\n* Male patients with pregnant or lactating partners must be advised to use barrier method contraception (e.g. condom) to prevent drug exposure of the foetus or neonate.\n\nAll male patients must refrain from donating sperm for the same period.\n\nD. Patients must be able and willing to undergo a fresh tissue biopsy at baseline and blood samples for translational research. Note that for patients with haematological malignancies or neuroblastomas, blood, bone marrow aspiration and\u002For trephine or lymph node biopsy samples may be taken.\n\nE. ADULT PATIENTS (≥18 years): Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility.\n\nF. PAEDIATRIC PATIENTS (\\\u003C18 years): Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility.\n\nG. Patients must have stable thyroid function tests. Patients on stable doses of thyroxine replacement are permitted.\n\nExclusion Criteria:\n\nA. Diagnosis of urothelial cancer, non-small cell lung cancer, extensive-stage small cell lung cancer, hepatocellular carcinoma or triple negative breast cancer.\n\nB. Patients with rapidly progressing or symptomatically deteriorating brain metastases and\u002For leptomeningeal disease. Patients with previously treated brain metastases are eligible, provided the patient has not experienced a seizure or had a clinically significant change in neurological status within 14 days (for adult patients) or 7 days (for paediatric patients) prior to the start of IMP administration. Such patients must be non-dependent on steroids or on a stable or reducing dose of steroid treatment for at least 14 days (or 7 days for paediatric patients) prior to the start of IMP administration. Primary brain or central nervous system (CNS) malignancies are allowed providing the patient is clinically stable (if requiring corticosteroids must be at stable or decreasing doses for at least 14 days for adults and 7 days for paediatric patients prior to the start of IMP administration). Patients who have received brain irradiation must have completed whole-brain radiotherapy and\u002For stereotactic radiosurgery at least 14 days prior to the start of IMP administration.\n\n• Paediatric patients with either primary brain tumours or extracranial solid tumours with intracranial metastases with one or more intracranial lesions should only be considered for inclusion if largest intracranial lesion is ≤6 cm in longest axis. Consideration should also be given to the intracranial location of the tumour and potential risk should swelling occur. This is because of the class risk of immune checkpoint inhibitors such as atezolizumab causing immune-mediated inflammatory response and 'tumour flare' which may result in acute neurological deterioration.\n\nC. Female patients who are pregnant, breastfeeding or planning to become pregnant during the trial or within five months following their last dose of atezolizumab.\n\nD. History or clinical evidence of current inflammatory lung disease:\n\n* History of idiopathic pulmonary fibrosis, organising pneumonia (e.g. bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.\n* Evidence of active pneumonitis on screening chest computed tomography (CT) scan.\n\nE. Active autoimmune disease that requires the use of systemic immunomodulatory therapy (i.e. with disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy for hypothyroidism and adrenal or pituitary insufficiency is acceptable.\n\nF. Ongoing lung pathologies which, in the opinion of the Investigator present a compromise to safety (e.g. active tuberculosis).\n\nG. Systemic immunomodulatory agents within 14 days prior to trial entry (immunostimulatory agents within four weeks). Exceptions to this are:\n\n* Patients who received acute, low dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g. 48 hours of corticosteroids for a contrast allergy) are eligible for the trial.\n* Patients who received corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma equivalent to ≤10 mg prednisolone a day or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the trial.\n* Patients with primary CNS disease can be receiving concurrent treatment with corticosteroids. Patients must be receiving a stable or decreasing dose for ≥14 days for adults and ≥7 days for paediatric patients prior to the screening magnetic resonance imaging (MRI) scan and at the time of drug initiation.\n* Patients who receive physiological doses of steroid replacement (e.g. hydrocortisone) are permitted.\n\nH. Known to be serologically positive (as detected by polymerase chain reaction) for hepatitis B, hepatitis C or human immunodeficiency virus (HIV).\n\nI. History of severe allergic anaphylactic reactions to chimeric, human or humanised antibodies, or fusion proteins including other immune checkpoint inhibitors.\n\nJ. Known hypersensitivity to Chinese hamster ovary cell products.\n\nK. Known hypersensitivity to atezolizumab or any of the excipients.\n\nL. Patients who were administered a live, attenuated vaccine within 28 days prior to enrolment, or anticipation of need for such a vaccine during atezolizumab treatment or within six months after the final dose of atezolizumab.\n\nM. Patients with clinically significant pre-existing cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias, or NYHA class III or IV congestive heart failure.\n\nPatients with a cerebrovascular event (including stroke or transient ischaemic attacks \\[TIA\\]) or cardiovascular event (including acute myocardial infarction \\[MI\\]) within three months before the first dose of atezolizumab.\n\n• Patients with primary CNS tumours may be considered unless intra-tumoural bleeding has occurred within 2 weeks of the first dose of atezolizumab, and patients with punctate CNS haemorrhages \\\u003C3 mm may be considered.\n\nPatients with a prior history of pericardial disorders, including pericarditis, pericardial effusion and cardiac tamponade.\n\nN. Prior allogeneic stem cell or solid organ transplantation on immunosuppression.\n\nO. Prior treatment with the same class of drug unless genetic profile demonstrates a mechanism of resistance known to be potentially sensitive to atezolizumab.\n\nP. Uncontrolled diabetes.\n\nQ. Any clinically significant concomitant disease or condition (or its treatment) that could interfere with the conduct of the trial or absorption of oral medications or that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this trial.\n\nR. Severe infection within four weeks prior to the first IMP administration or the administration of antibiotics within two weeks prior to the first IMP administration, with the exemption of patients requiring prophylaxis.",{"count":175,"type":19},[177,178],"This clinical trial is looking at a drug called atezolizumab. Atezolizumab is approved as standard of care treatment for adult patients with urothelial cancer, non-small cell lung cancer, extensive-stage small cell lung cancer, hepatocellular carcinoma and triple negative breast cancer. This means it has gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.\n\nAtezolizumab works in patients with these types of cancers which have certain changes in the cancer cells called high tumour mutational burden (TMB) or high microsatellite instability (MSI) or proven (previously diagnosed) constitutional mismatch repair deficiency (CMMRD).\n\nInvestigators now wish to find out if it will be useful in treating patients with other cancer types which are also TMB\u002FMSH-high or show CMMRD. If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future.\n\nThis trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.",[23,183,232,184,185,186,261,262,234,263],"Colorectal Neoplasms","Endometrial Neoplasms","Solid Tumours",[236,200,265,186,237,23,203,204,184,185,241,206,208,209,243],"Atezolizumab",{"date":213,"type":28},{"date":268,"type":28},"2023-10-25",{"date":217,"type":19},{"name":219,"class":35},{"id":272,"slug":273,"hasResults":11,"nctId":274,"briefTitle":275,"officialTitle":275,"acronym":276,"eligibilityCriteria":277,"healthyVolunteers":11,"sex":16,"minAge":44,"maxAge":4,"enrollmentInfo":278,"targetDuration":4,"studyType":47,"phases":280,"briefSummary":281,"conditions":282,"keywords":4,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":296},"100515504","tandem-polyurethane-stents-compared-to-single-silicone-stent-for-malignant-ureteral-obstruction-100515504","NCT05992363","Tandem Polyurethane Stents Compared to Single Silicone Stent for Malignant Ureteral Obstruction","TSTENT","Inclusion Criteria:\n\n* patient with malignant ureteral obstruction\n\nExclusion Criteria:\n\n* ureteral obstruction of other causes\n* Language comprehension or other limitation in giving informed consent",{"count":279,"type":19},106,[49],"Malignant ureteral obstruction (MUO) is an extrinsic ureteral obstruction caused by malignant diseases. This study aim to compare tandem 6 Fr Percuflex™ stents and single large-caliber 8Fr silicone stent in patients with MUO. The primary endpoint is stent failure rate. The secondary endpoints are patient comfort, quality of life and overall survival.",[283,284,23,285,286],"Hydronephrosis; Obstruction, Ureter","Renal Failure","Ureter Obstruction","Ureter Stricture","2025-07-22",{"date":289,"type":28},"2025-07-24",{"date":291,"type":28},"2023-12-20",{"date":293,"type":19},"2027-12",{"name":295,"class":35},"Rabin Medical Center",2,{"id":298,"slug":299,"hasResults":11,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":4,"eligibilityCriteria":303,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":304,"targetDuration":4,"studyType":47,"phases":306,"briefSummary":308,"conditions":309,"keywords":311,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":319,"leadSponsor":321,"locationsCount":296},"100576769","phase-1-evaluating-informatics-assisted-immune-related-adverse-event-detection-to-improve-registration-onto-a-biorepository-100576769","NCT06789601","Evaluating Informatics-assisted Immune-related Adverse Event Detection to Improve Registration Onto a Biorepository","A Non-Interventional Pragmatic Clinical Trial of NLP Models for the Detection of Immune-Related Adverse Events","Inclusion Criteria:\n\n* Received or receiving a regimen containing one or more immuno-oncology therapeutics",{"count":305,"type":19},100,[307,177],"PHASE1","Immunotherapies have improved cancer outcomes, but have a unique profile of immune-related adverse events (irAEs). Biorepositories have been established to collect data and samples to help improve our understanding of irAEs, however identifying patients who are eligible for these biorepositories in a timely fashion can be challenging. The goal of this study is to determine if an informatics system for automated irAE detection can improve registration to a prospective irAE biorepository (NCT04242095). The informatics system automatically \"reads\" participants' electronic health records (EHRs) and determines whether that patient may be experiencing an irAE. The main questions it aims to answer are:\n\n* Is it feasible to implement an informatics system for daily analysis of EHR data to detect irAEs?\n* Does the automated irAE detection system improve registration rates to an irAE biorepository at our institution following an eligible irAE?\n\nResearchers will compare standard irAE monitoring to informatics-assisted irAE monitoring to see if using the informatics system increases the registration rate and improves data entry efficiency and quality.\n\nParticipants will:\n\n* Be randomly assigned to standard monitoring or informatics-assisted monitoring for irAE detection.\n* Have their EHR reviewed to collect demographic, medical, and cancer treatment history.\n* Be monitored for irAEs through daily automated analysis of their EHR data for up to 12 months or until registration in the biorepository.",[23,310],"Immune Related Adverse Events",[202,312,313,314],"adverse drug event","health informatics","natural language processing","2025-06-17",{"date":317,"type":28},"2025-06-19",{"date":315,"type":28},{"date":320,"type":19},"2027-08-31",{"name":322,"class":35},"Brigham and Women's Hospital",{"id":324,"slug":325,"hasResults":11,"nctId":326,"briefTitle":327,"officialTitle":327,"acronym":4,"eligibilityCriteria":328,"healthyVolunteers":11,"sex":16,"minAge":44,"maxAge":4,"enrollmentInfo":329,"targetDuration":4,"studyType":47,"phases":330,"briefSummary":331,"conditions":332,"keywords":333,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":69},"100497755","phase-2-application-of-18f-psma-pet--ct-imaging-in-prostate-specific-membrane-antigen-positive-tumor-100497755","NCT05761366","Application of 18F-PSMA PET \u002F CT Imaging in Prostate Specific Membrane Antigen Positive Tumor","Inclusion Criteria:\n\n1. Patients with suspected or clearly diagnosed PSMA positive-expressing tumors, including prostate cancer, transitional epithelial carcinoma, colon carcinoma, adenoid cystadenocarcinoma, mesothelioma, hepatocellular carcinoma, cholangiocellular carcinoma, multiple myeloma, etc.\n2. Age is 18 or older; No gender limitation.\n3. Signed the informed consent.\n4. Willing and able to cooperate with all projects in this study.\n\nExclusion Criteria:\n\n1. Patients with serious neurological diseases,or gastrointestinal tract disease, cardiovascular disease, liver disease, kidney disease, blood system disease, endocrine system disease, respiratory system disease, immune deficiency disease, etc\n2. Claustrophobia.\n3. Pregnant or lactation women.\n4. Received experimental drug or device within 1 month.",{"count":133,"type":19},[177],"In this study, Al18F-PSMA-BCH PET\u002FCT will be performed in patients with prostate specific membrane antigen positive tumor, to evaluate the tumour detection efficacy of Al18F-PSMA-BCH PET\u002FCT.",[23],[23,334],"Prostate Specific Membrane Antigen Positive Tumor","2024-12-21",{"date":337,"type":28},"2024-12-27",{"date":339,"type":28},"2022-10-13",{"date":341,"type":19},"2025-10-13",{"name":343,"class":35},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":345,"slug":346,"hasResults":11,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":350,"eligibilityCriteria":351,"healthyVolunteers":11,"sex":16,"minAge":352,"maxAge":4,"enrollmentInfo":353,"targetDuration":4,"studyType":47,"phases":355,"briefSummary":356,"conditions":357,"keywords":360,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":370,"lastUpdatePostDateStruct":371,"startDateStruct":373,"completionDateStruct":374,"leadSponsor":376,"locationsCount":69},"100462467","phase-1-allogeneic-nkg2dl-targeting-car--t-cells-ctm-n2d-in-advanced-cancers-angelica-100462467","NCT05302037","Allogeneic NKG2DL-targeting CAR γδ T Cells (CTM-N2D) in Advanced Cancers (ANGELICA)","A Phase I Trial to Evaluate Allogeneic NKG2DL-targeting Chimeric Antigen Receptor-grafted γδ T Cells (CTM-N2D) in Subjects With Advanced Solid Tumours or Haematological Malignancies (the ANGELICA Trial)","ANGELICA","Inclusion Criteria:\n\n* At least 21 years of age\n* Provision of signed and dated, written informed consent prior to any study specific procedures, sampling, and analyses (if applicable, the written informed consent may include access to all archival tumour tissue, e.g., diagnostic and\u002For most recent samples for correlative study)\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 and an estimated life expectancy of greater than 12 weeks\n* Females of reproductive age group must be on effective contraception (if sexually active), must not be breast feeding and must have a negative pregnancy test prior to the start of lymphodepletion.\n* For the duration of the study and for 1 week after the last study drug administration, sexually active male patients must be willing to use barrier contraception (i.e., condoms) with all sexual partners. Where the sexual partner is a 'woman of child-bearing potential' who is not using effective contraception, the male patients must use a condom (with spermicide) during the study and for 6 months after the last dose of a study drug.\n* Adequate hepatic, renal and lung function as demonstrated by any of the following laboratory values:\n\n  * AST or ALT ≤ 3 x ULN\n  * Total bilirubin ≤ 1.5 x ULN\n  * Glomerular filtration rate (GFR) \\> 50 mL\u002Fmin, as assessed using the Cockroft-Gault formula or 24 h urine creatinine collection\n  * SpO2 on room air \\> 94%\n* Adequate bone marrow reserve as demonstrated by any of the following laboratory values:\n\n  * Absolute neutrophil count (ANC) ≥ 1.0x10\\^9\u002FL\n  * Platelet count ≥ 75 x 10\\^9\u002FL\n  * Haemoglobin ≥ 9.0 g\u002FdL\n* Patients must have a metastatic cancer resistant to or deemed unsuitable for at least two standard lines of cancer therapy regimens, as part of their management of recurrent\u002Fpersistent disease.\n* Presence of measurable tumour by RECIST 1.1 criteria\n* Serum 25 Hydroxyvitamin D total ≥ 20ng\u002Fml\n* Have a diagnosis of cancer that is known to express NKG2D ligands\n\nExclusion Criteria:\n\n* With the exception of alopecia, any unresolved toxicities from prior therapy ≥ the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grade 2\n* Spinal cord compression or brain metastases unless asymptomatic, stable and not requiring steroids for at least 4 weeks prior to the start of lymphodepletion\n* As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, active bleeding diatheses, renal transplant, or active infection including any patient known to have human immunodeficiency virus (HIV) or hepatitis virus. Screening for chronic conditions is not required.\n* All HBsAg-positive patients (For HBsAg-negative, but anti-HBc total-positive patients, HBV viral load will be further tested. If HBV viral load is negative, patients may be included.)\n* Active or prior documented autoimmune or inflammatory disorders including inflammatory bowel disease (e.g., colitis or Crohn's disease), diverticulitis (with the exception of diverticulosis), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome (granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc). The following are exceptions to this criterion:\n\n  * Subjects with vitiligo or alopecia\n  * Subjects with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement\n  * Any chronic skin condition that does not require systemic therapy\n  * Subjects without active disease in the last 5 years may be included but only after consultation with the medical monitor\n  * Subjects with celiac disease controlled by diet alone\n  * For other autoimmune or inflammatory conditions not specifically mentioned, discuss on case-by-case basis with investigator and medical monitor\n* Concurrent severe and\u002For uncontrolled medical condition (e.g., severe COPD, severe Parkinson's disease, active inflammatory bowel disease) or psychiatric condition (screening for chronic disease is not required)\n* Female patients who are breast-feeding or patients of reproductive potential who are not employing an effective method of contraception\n* Receiving, or having received during the four weeks prior the start of lymphodepletion, any investigational product\n* Treatment with any investigational biological product (e.g., immune check point blockers, antibodies, nanoparticles, experimental) during the four weeks prior the start of lymphodepletion\n* Patients who underwent major surgery during the four weeks prior to the start of lymphodepletion\n* Radiation (except planned or ongoing palliative radiation to bone outside of the region of measurable disease) during the three weeks prior to the start of Lymphodepletion\n* Active infection requiring systemic long-term (\\> 2 weeks) treatment with antibiotics, antifungal or antiviral drugs\n* Cardiac dysfunction as defined as: Myocardial infarction within six months of study entry, NYHA Class II\u002FIII\u002FIV heart failure, unstable angina, unstable cardiac arrhythmias or reduced LVEF \\\u003C 50%.\n* Any of the following cardiac criteria:\n\n  * Mean resting corrected QT interval (QTc) \\> 470 msec\n  * Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block)\n  * Uncontrolled hypertension requiring clinical intervention\n* Failed dental clearance (for zoledronic acid administration)\n* Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements\n\nSubject Withdrawal Criteria\n\nTreatment may continue until one of the following criteria applies:\n\n* Disease progression\n* Intercurrent illness that prevents further administration of treatment\n* Unacceptable adverse event(s)\n* Intolerable non-hematologic toxicities ≥ NCI CTCAE v5.0 Grade 2\n* Unmanageable hematologic or non-hematologic toxicities ≥ NCI CTCAE v5.0 Grade 3\n* General or specific changes in the patient's condition that renders the patient unsuitable for further treatment at the discretion of the investigator\n* Patient who cannot recover from adverse event(s) and lead to treatment delay for \\> 4 weeks\n* Patient who decides to withdraw from the study","21 Years",{"count":354,"type":19},12,[307],"CAR-T is a pioneering cancer treatment which has found success in some cancers. This treatment is made first by taking blood cells from the patient. Then in the lab, an artificial protein - a Chimeric Antigen Receptor (CAR), is grafted on the surface of immune cells. The modified cells, which are readministered to the patient, have enhanced abilities to target and destroy cancers than unmodified immune cells.\n\nCurrently approved CAR-T can only be used autologously. i.e. the patient will receive CAR-T treatment made from their own cells. This is because current CAR-T treatment uses αβ T cells - a type of immune cell which are largely non-transferable between individual human beings due to the high risk of Graft-versus-Host Disease. However, autologous CAR-T comes with many limitations. A lengthy, manufacturing process follows after the patient donates their own blood, accompanied by a high risk of manufacturing failure, which can be attributed to the cell quality from cancer patients undergoing stressful anti-cancer therapy.\n\nCytoMed Therapeutics pioneers a new CAR-T treatment (CTM-N2D) which may confer some benefit over current CAR-T treatment. CTM-N2D uses a subtype of immune cell -- γδ T cell. Secondly, the CAR on CTM-N2D targets a surface antigen called NKG2DL which are commonly present in many cancer. These two features may confer a safer product profile, of better quality and may be efficacious in cancers where previous CAR-T treatments has not.\n\nThe phase I clinical trial of CTM-N2D will be conducted at the National University Hospital, Singapore. The objective of this clinical trial is to determine the optimal dose of CTM-N2D, and to investigate its safety and tolerability. The subjects of the clinical trial will also be investigated for their tumour response to CTM-N2D.\n\nCTM-N2D has undergone preclinical studies. Relevant data from other clinical trials are also used to infer the expected outcome, and strategies of management of this clinical trial. The institution's ethical review board must give its approval before the study may begin. An independent Data Safety Monitoring Board monitors the safety aspect of this trial.",[186,23,358,359],"Refractory Cancer","Relapsed Cancer",[201,202,361,362,363,364,365,366,367,368,369],"solid cancer","solid tumours","haematological cancer","haematological malignancy","refractory cancer","relapsed cancer","CAR-T","cell therapy","gamma delta","2024-11-20",{"date":372,"type":28},"2024-11-22",{"date":215,"type":28},{"date":375,"type":19},"2026-12",{"name":377,"class":378},"CytoMed Therapeutics Pte Ltd","INDUSTRY",{"id":380,"slug":381,"hasResults":11,"nctId":382,"briefTitle":383,"officialTitle":384,"acronym":4,"eligibilityCriteria":385,"healthyVolunteers":11,"sex":16,"minAge":44,"maxAge":4,"enrollmentInfo":386,"targetDuration":4,"studyType":47,"phases":388,"briefSummary":389,"conditions":390,"keywords":393,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":69},"100568569","feasibility-of-ambulatory-talc-pleurodesis-100568569","NCT06682936","Feasibility of Ambulatory Talc. Pleurodesis","Can Talc Pleurodesis for Malignant Pleural Effusion be Performed on an Ambulatory Basis","Inclusion Criteria:\n\n* Malignant pleural effusion\n* Life expectancy \\>30 days\n* WHO PS 1-2 (3 if due to dyspnoea)\n\nExclusion Criteria:\n\n* Previous failed pleurodesis (on affected side)\n* Known non-expansile lung",{"count":387,"type":19},15,[49],"Patients with malignant pleural disease often experience a significant symptom burden and a short life expectancy. The cornerstone of their treatment is relieving breathlessness by draining fluid from around the lungs and attempting to prevent further fluid build up. Inpatient chest drainage and talc pleurodesis remains the most successful method of stopping the fluid build up but this often requires an average hospital stay of four days. This can be an inappropriate length of time for this patient group. Our study would investigate whether this treatment could be provided on an outpatient, ambulatory basis and facilitate a greater quality of life.\n\nThe investigators would assess deliverability of the trial protocol and collect patient feedback to see if our patients consider it an acceptable and worthwhile intervention.",[391,23,392],"Malignant Pleural Effusion","Palliative Care",[394,202,395],"malignant pleural effusion","palliative care","2024-11-08",{"date":398,"type":28},"2024-11-12",{"date":400,"type":28},"2024-01-10",{"date":402,"type":19},"2025-02",{"name":404,"class":35},"David Rollins",{"id":406,"slug":407,"hasResults":11,"nctId":408,"briefTitle":409,"officialTitle":409,"acronym":4,"eligibilityCriteria":410,"healthyVolunteers":411,"sex":16,"minAge":412,"maxAge":4,"enrollmentInfo":413,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":415,"conditions":416,"keywords":419,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":423,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":69},"100469219","identification-of-risk-factors-for-cardiovascular-disease-and-cancer-in-korean-population-a-prospective-cohort-study-100469219","NCT05389956","Identification of Risk Factors for Cardiovascular Disease and Cancer in Korean Population: A Prospective Cohort Study","Inclusion Criteria:\n\n* Men or women aged 19 years and older who underwent a general health screening at the health promotion center of Ulsan University Hospital (Ulsan, Korea)\n* Subjects have to agree to participate by signing a consent\n\nExclusion Criteria:\n\n* Subjects who cannot or reject to sign the consent form.",true,"19 Years",{"count":414,"type":19},510000,"Cancer and cardiovascular disease are the global leading causes of death. These two disease entities are multifactorial disease that are caused by several factors. The aim of this prospective cohort study was to investigate the status of risk factors profiles and health related behavior in Korean population, and to discover novel risk factors associated with the occurrence of endpoint events.",[417,23,418],"Cardiovascular Diseases","Risk Factor",[420,23,421],"Cardiovascular disease","Risk factor","2024-03-18",{"date":424,"type":28},"2024-03-19",{"date":426,"type":28},"2023-01-01",{"date":428,"type":19},"2052-08",{"name":430,"class":35},"Ulsan University Hospital",{"id":432,"slug":433,"hasResults":11,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":4,"eligibilityCriteria":437,"healthyVolunteers":11,"sex":16,"minAge":44,"maxAge":4,"enrollmentInfo":438,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":440,"conditions":441,"keywords":442,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":457,"locationsCount":69},"100438641","bostongene-integrated-genomic-registry-bigr-100438641","NCT04991922","BostonGene-Integrated Genomic Registry (BIGR)","BostonGene-Integrated Genomic Registry Study","Inclusion Criteria:\n\n1. Suspected or confirmed malignancy\n2. Planned comprehensive genomic (\\> 100 genes) and\u002For molecular analysis; or genomic and\u002For molecular data available from prior sequencing\n3. Baseline demographics and treatment information available\n4. Willingness for future contact by BIRG study personnel to provide information regarding associated cancer outcomes and treatment.\n5. Signed informed consent to participate in the study.\n6. Living in the United States at the time of enrollment\n\nExclusion Criteria:\n\nLife expectancy \\\u003C 3 months",{"count":439,"type":19},100000,"The purpose of this project is to develop a comprehensive database of genomic, transcriptomic, molecular, and clinical characteristics of oncology patients to discover, define, and develop genomic and transcriptomic markers to improve future clinical outcomes across cancer types",[23],[201,443,444,445,446,447,448,449],"precision medicine","WES","RNA-seq","immuno-therapy","genomic","transcriptomic","multiomic","2024-02-06",{"date":452,"type":28},"2024-02-07",{"date":454,"type":28},"2021-07-01",{"date":456,"type":19},"2036-07-01",{"name":458,"class":378},"BostonGene",{"id":460,"slug":461,"hasResults":11,"nctId":462,"briefTitle":463,"officialTitle":464,"acronym":4,"eligibilityCriteria":465,"healthyVolunteers":11,"sex":16,"minAge":466,"maxAge":44,"enrollmentInfo":467,"targetDuration":4,"studyType":47,"phases":468,"briefSummary":470,"conditions":471,"keywords":474,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":481,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":69},"100399018","phase-4-propofol-vs-sevo-for-paediatric-tumor-surgery-100399018","NCT04475705","Propofol vs Sevo for Paediatric Tumor Surgery","The Effects of Propofol Based Intravenous vs Sevoflurane Inhalation Anaesthesia on Inflammation and Circulating Tumor Cells in Paediatric Tumor Surgery - a Pilot Study","Inclusion Criteria:\n\n* patients coming for elective primary solid tumor resection for curative intent in Hong Kong Children's Hospital\n* AND patients \\> 5kg\n* AND patients within age limit\n\nExclusion Criteria:\n\n* Autoimmune \u002F Chronic inflammatory diseases e.g. Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis (RA) etc.\n* Current Steroid therapy\n* Surgery for tumour removal in the past year\n* Allergy to Propofol\n* intraoperative use of nitrous oxide\n* Patient susceptible to Malignant Hyperthermia\n* Patients \u002F parents \u002F legal guardians showing preference in anaesthetic techniques during recruitment process","6 Months",{"count":305,"type":19},[469],"PHASE4","Background:\n\nRetrospective studies and meta-analyses have shown a reduction in 5-year survival following inhalational based compared to propofol based total intravenous (TIVA) anaesthesia for cancer surgery. To date there have been no prospective trials published which evaluate the effect of anaesthetic technique on circulating tumour cells (CTC), oxidative stress, and recurrence rate following cancer surgery. Children with cancer often require surgery for tumour excision as well as for other diagnostic and therapeutic procedures. To date there has been no prospective randomized controlled trial evaluating the optimal anaesthetic technique for surgery on children with cancer.\n\nAim:\n\nThis is a pilot study in paediatric patients who require surgery for tumour excision. The aim is to investigate the effect of sevoflurane inhalational versus propofol intravenous anaesthesia on expression of hypoxia-inducible factor 1 (HIF-1), circulating tumour cells, DNA damage and biomarkers of immunity and inflammation in patients before and after tumour surgery. The patients will be followed up for up to 5 years for tumour recurrence after surgery.\n\nMethod:\n\nThis will be a single-blinded randomized controlled trial. One hundred children undergoing tumour excision surgery at the Hong Kong Children's Hospital will be recruited and randomized to receive TIVA or inhalational anaesthesia. Baseline, intraoperative and postoperative blood will be taken for tests of immunity and inflammatory markers, DNA damage and circulating tumour cells. Patients would be followed up to 3 years for tumour recurrence and survival.",[472,473,23,186],"Solid Tumor","Carcinoma",[475,476,477,478,479],"propofol","sevoflurane","cancer surgery","circulating tumor cells","paediatric","2022-03-14",{"date":482,"type":28},"2022-03-16",{"date":484,"type":28},"2021-01-11",{"date":486,"type":19},"2028-07",{"name":488,"class":35},"Hong Kong Children's Hospital"]