[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"skin-neoplasm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:skin-neoplasm":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,81,105],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100597708","minibeam-radiation-therapy-with-tungsten-slit-collimator-for-the-treatment-of-recurrent-or-metastatic-skin-or-soft-tissue-tumors-100597708",false,"NCT07062003","Minibeam Radiation Therapy With Tungsten Slit Collimator for the Treatment of Recurrent or Metastatic Skin or Soft Tissue Tumors","A Dose Finding Study of MiniBeam RadioTherapy for Skin and Superficial Soft Tissue Tumors (MBRT1)","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Histologically confirmed malignancy\n* Primary, recurrent, or metastatic skin or superficial soft tissue tumor amenable to palliative orthovoltage radiotherapy\n* Anticipated life expectancy ≥ 30 days and anticipated capacity for follow up for ≥ 30 days\n* Negative pregnancy test done ≤ 28 days prior to registration, for biological women of childbearing potential only\n* Willing to provide written informed consent\n* Willing to allow baseline and follow up photograph acquisition for response and toxicity assessment\n* Willing and able to return to enrolling institution for follow-up during the active monitoring phase of the study\n* Willing to provide blood and tissue samples for correlative research purposes\n\nExclusion Criteria:\n\n* Hematologic, germ cell, or any other tumor that the investigational team would deem to have a high likelihood of clinical complete response with standard palliative radiotherapy (8 Gy in 1, 30 Gy in 10, etc.)\n* COHORT A (INTACT SKIN) ONLY: Prior radiotherapy targeting the lesion presenting for treatment or prior adjacent radiotherapy if \\> 10 Gy overlaps with a portion of the planned target\n* Treatment with a B-Raf proto-oncogene, serine\u002Fthreonine kinase (BRAF) inhibitor, monoclonal antibodies targeting vascular endothelial growth factor (VEGF) (bevacizumab or ramucirumab) or small molecule inhibitors inhibiting VEGF within the last 2 weeks or planned treatment with BRAF inhibitor within 4 weeks after radiation\n* Treatment with an investigational drug therapy within 2 weeks prior to or 4 weeks (the DLT monitoring period) after MBRT\n* Any tumor with direct extension into the spine such that targeting the spine\u002Fspinal cord could not be avoided","ALL","18 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"NA","This clinical trial tests the safety and best dose of minibeam radiation therapy (MBRT) with a tungsten slit collimator for treating patients with skin or soft tissue tumors that have come back after a period of improvement (recurrent) or that spread from where they first started (primary site) to other places in the body (metastatic). Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Tungsten is an extremely dense metal and is commonly used for blocking x-rays for minimum radiation exposure. A tungsten slit collimator is a device that separates an initially wide beam of x-rays into several very narrow individual beams of radiation. As radiation passes through the collimator, the radiation hits regions of solid tungsten and is blocked. In the open slit regions, radiation passes through to the intended target\u002Ftumor area defined by the physician. The tungsten slit collimator then selectively blocks portions of the radiation to create an alternating pattern of higher \"peak\" and lower \"valley\" radiation dose regions. These narrow beams of radiation are referred to as \"minibeams\" and the general approach referred to as MBRT.",[26,27,28,29,30,31],"Metastatic Malignant Skin Neoplasm","Metastatic Malignant Soft Tissue Neoplasm","Recurrent Malignant Skin Neoplasm","Recurrent Malignant Soft Tissue Neoplasm","Skin Neoplasm","Soft Tissue Neoplasm","RECRUITING","2026-06-02",{"date":35,"type":36},"2026-06-04","ACTUAL",{"date":38,"type":36},"2025-08-11",{"date":40,"type":20},"2028-08-01",{"name":42,"class":43},"Mayo Clinic","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":68,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":44},"100640818","studying-the-workflow-of-the-american-college-of-surgeons-geriatric-surgery-program-to-improve-clinical-outcomes-in-older-adults-undergoing-surgery-at-the-james-cancer-hospital-100640818","NCT07606287","Studying the Workflow of the American College of Surgeons Geriatric Surgery Program to Improve Clinical Outcomes in Older Adults Undergoing Surgery at the James Cancer Hospital","Implementation of the American College of Surgeons Geriatric Surgery Verification Program at the James Cancer Hospital","Inclusion Criteria:\n\n1. Patient records for adults aged 65 years or older\n2. Patient records with a surgical encounter or preoperative evaluation within participating James Cancer Hospital surgical oncology services during the rollout period\n3. Patient records with data available in institutional electronic health record or institutional data systems\n4. Clinical staff age 18 years or older who are employed or credentialed at The Ohio State University Wexner Medical Center and work within clinical areas affected by ACS Geriatric Surgery Verification implementation\n\nExclusion Criteria:\n\n1. Patient records for encounters occurring only at outside institutions or non-James hospitals within the enterprise\n2. Patient records missing all primary outcome fields after data quality checks\n3. Clinical staff who are trainees, including medical students, physician assistant students, nursing students, resident physicians, or fellows\n4. Clinical staff whose employment, visa, or institutional status would make participation sensitive under institutional policy, if applicable",true,{"count":54,"type":20},4000,[23],"This study examines how the American College of Surgeons Geriatric Surgery Verification Program, also called the ACS GSV Program, is implemented at the James Cancer Hospital. The program is designed to improve surgical care for adults age 65 and older by helping care teams identify and address age-related needs before, during, and after surgery.\n\nOlder adults with cancer may have concerns related to physical function, memory or thinking, medications, social support, and goals of care. If these needs are not recognized, patients may be at higher risk for complications, longer hospital stays, readmission, or discharge to a facility instead of home.\n\nThe ACS GSV Program includes standards for geriatric surgery leadership, goals-of-care discussions, screening for age-related vulnerabilities, care plans for identified needs, age-friendly perioperative care, and regular review of surgical outcomes. This study will evaluate how well these standards are adopted across surgical oncology services and whether implementation is associated with better outcomes, such as shorter hospital stays, fewer complications, fewer readmissions, and improved discharge outcomes.\n\nThe results may help improve surgical care workflows for older adults undergoing cancer surgery.",[58,59,60,61,62,63,64,65,30,31,66,67],"Breast Carcinoma","Malignant Digestive System Neoplasm","Malignant Female Reproductive System Neoplasm","Malignant Genitourinary System Neoplasm","Malignant Head and Neck Neoplasm","Malignant Nervous System Neoplasm","Malignant Solid Neoplasm","Malignant Thoracic Neoplasm","Central Nervous System Neoplasm","Endocrine Gland Neoplasms",[69,70],"geriatric surgery verification","oncogeriatrics","NOT_YET_RECRUITING","2026-05-27",{"date":74,"type":36},"2026-05-29",{"date":76,"type":20},"2026-06-15",{"date":78,"type":20},"2027-12-31",{"name":80,"class":43},"Ohio State University Comprehensive Cancer Center",{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":21,"phases":90,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"100609328","optical-imaging-scans-for-the-diagnosis-of-skin-cancer-in-patients-with-lesions-100609328","NCT07213154","Optical Imaging Scans for the Diagnosis of Skin Cancer in Patients With Lesions","Assessment of Novel Label-free Optical Imaging Technology for the Evaluation of Skin Lesions","Inclusion Criteria:\n\n* Male or Female\n* Candidate with skin lesions\n* Signed study-specific informed consent prior to study entry\n* ≥ 18 years old\n\nExclusion Criteria:\n\n* Prior surgery or radiotherapy to the area to be treated",{"count":89,"type":20},10,[23],"This clinical trial studies how well an optical imaging scan called quantitative oblique back-illumination microscopy (qOBM) helps in diagnosing skin cancer in patients with skin lesions. qOBM is a non-invasive procedure that uses red light for illumination, and may work better than no imaging procedures in aiding doctors in diagnosing skin lesions.",[93,94,30],"Malignant Skin Neoplasm","Skin Disorder","2025-12-11",{"date":97,"type":36},"2025-12-16",{"date":99,"type":36},"2025-10-15",{"date":101,"type":20},"2027-09-17",{"name":103,"class":43},"Emory University",2,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":113,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":21,"phases":116,"briefSummary":119,"conditions":120,"keywords":131,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":156},"100499704","phase-2-determine-trial-treatment-arm-04-trastuzumab-in-combination-with-pertuzumab-in-adult-paediatric-and-teenageyoung-adult-patients-with-cancers-with-her2-amplification-or-activating-mutations-100499704","NCT05786716","DETERMINE Trial Treatment Arm 04: Trastuzumab in Combination With Pertuzumab in Adult, Paediatric and Teenage\u002FYoung Adult Patients With Cancers With HER2 Amplification or Activating Mutations","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 04: Trastuzumab in Combination With Pertuzumab in Adult, Paediatric and Teenage\u002FYoung Adult Patients With Cancers With HER2 Amplification or Activating Mutations.","DETERMINE","THE PATIENT MUST FULFIL THE ELIGIBILITY CRITERIA WITHIN THE DETERMINE MASTER PROTOCOL (NCT05722886) AND WITHIN THE TREATMENT ARM 04 (TRASTUZUMAB AND PERTUZUMAB) OUTLINED BELOW\\*\n\n\\*When trastuzumab- and pertuzumab-specific inclusion\u002Fexclusion criteria or precautions below differ from those specified in the Master Protocol, the trastuzumab- and pertuzumab-specific criteria will take precedence.\n\nInclusion Criteria:\n\nA. Confirmed diagnosis of a malignancy harbouring HER2 amplification, or an appropriate activating mutation as defined by the MTB, using an analytically validated next-generation sequencing method.\n\n• A HER2 amplification copy number between 5-9 will require an MTB discussion. A HER2 amplification copy number ≥10 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. Age 12 years or above.\n\nC. Women of childbearing potential are eligible provided that they meet the following criteria:\n\nHave a negative serum or urine pregnancy test before enrolment and;\n\nAgree 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 trastuzumab or pertuzumab (whichever is first), throughout the trial and for seven months after the last administration of trastuzumab or pertuzumab (whichever is later).\n\nD. Male patients with partners who are women of childbearing potential are eligible provided that they agree to the following, from the first administration of trastuzumab or pertuzumab (whichever is first), throughout the trial and for seven months after the last administration of trastuzumab or pertuzumab (whichever is later):\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 an effective method of contraception as in C, 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\nE. 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\nF. 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\nG. 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\nExclusion Criteria:\n\nA. Diagnosis of HER2-positive early or metastatic breast cancer.\n\nB. Female patients who are pregnant, breastfeeding or planning to become pregnant during the trial or within seven months following their last dose of trastuzumab or pertuzumab (whichever is later).\n\nC. Severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy.\n\nD. Known hypersensitivity to trastuzumab or pertuzumab, murine proteins, or to any of the excipients.\n\nE. Patients who were administered a live, attenuated vaccine within 28 days prior to enrolment, or anticipation of need for such a vaccine during trastuzumab and pertuzumab treatment or within six months after the final dose of trastuzumab and pertuzumab.\n\nF. Patients with clinically significant pre-existing cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias (within three months), NYHA class III or IV congestive heart failure.\n\nLeft Ventricular Ejection Fraction \\\u003C55%.\n\nPatients with a cerebrovascular event (including stroke or transient ischaemic attack \\[TIA\\]) or cardiovascular event (including acute myocardial infarction \\[MI\\]) within three months before the first dose of trastuzumab and pertuzumab.\n\n• Patients with primary CNS tumours may be considered unless intra-tumoural bleeding has occurred within 2 weeks of the first dose of trastuzumab and pertuzumab, and patients with punctate CNS haemorrhages \\\u003C3 mm may be considered.\n\nG. Prior treatment with the same class of drug unless genetic profile demonstrates a mechanism of resistance known to be potentially sensitive to trastuzumab or pertuzumab.\n\nH. 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\nI. Known active infections (bacterial, fungal or viral) that would interfere with the assessment of safety or efficacy of trastuzumab and pertuzumab, 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.","12 Years",{"count":115,"type":20},30,[117,118],"PHASE2","PHASE3","This clinical trial is looking at a combination of drugs called trastuzumab and pertuzumab. This combination of drugs is approved together as standard of care treatment for adult patients with breast cancer (often with other anti-cancer drugs). This means it has gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.\n\nTrastuzumab and pertuzumab work in patients with these types of cancers which have a molecular alteration called HER2 amplification or HER2 activating mutation.\n\nInvestigators now wish to find out if it will be useful in treating patients with other cancer types which are also HER2 amplified or HER2 mutated. 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.",[121,122,123,124,125,126,127,128,129,30,130],"Haematological Malignancy","Colorectal Neoplasms","Urinary Bladder Neoplasm","Gallbladder Neoplasms","Salivary Gland Neoplasm","Lung Neoplasm","Pancreatic Neoplasm","Ovarian Neoplasms","Prostatic Neoplasm","Solid Tumour",[132,133,134,135,136,137,138,139,140,141,142,143,144,145,146],"Adult","Antibodies, monoclonal","Cancer","Child","Molecular Targeted Therapy","Mutation","Paediatric","Pertuzumab","Precision Medicine","Rare","Receptor, ErbB-2","Targeted","Trastuzumab","Tumour-agnostic","Young adult","2025-11-25",{"date":149,"type":36},"2025-12-02",{"date":151,"type":36},"2023-03-07",{"date":153,"type":20},"2029-10",{"name":155,"class":43},"Cancer Research UK",27]