[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"carcinoma-basal-cell\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:carcinoma-basal-cell":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,54],{"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":20,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":35,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100474888","oral-hedgehog-inhibitors-in-the-treatment-of-basal-cell-carcinoma-in-the-netherlands-a-prospective-registration-study-100474888",false,"NCT05463757","Oral Hedgehog Inhibitors in the Treatment of Basal Cell Carcinoma in the Netherlands: a Prospective Registration Study","Registration of Oral Hedgehog Inhibitors Vismodegib and Sonidegib in the Treatment of Advanced and Multiple Basal Cell Carcinoma in the Netherlands: a Prospective Registration Study.","Inclusion Criteria:\n\n* Men and women\n* All ages\n* Diagnosed with locally advanced basal cell carcinoma (laBCC), metastatic basal cell carcinoma (mBCC), multiple basal cell carcinomas or Gorlin syndrome\n* Use of oral hedgehog inhibitor vismodegib or sonidegib\n\nExclusion Criteria:\n\n* None","ALL",{"count":18,"type":19},80,"ESTIMATED","3 Years","OBSERVATIONAL","Background: Oral hedgehog inhibitors vismodegib and sonidegib have been used for the treatment of locally advanced (laBCC), metastatic basal cell carcinoma (mBCC) and in basal cell nevus syndrome (BCNS) patients. In the Netherlands, targeted therapy with vismodegib and sonidegib has been available since 2013 and 2021, respectively. No direct comparative studies have been performed between the two oral hedgehog inhibitors (HHI) vismodegib and sonidegib yet . In addition, data for sonidegib are not yet available.\n\nObjective: The aim of this study is 1) to evaluate the effectiveness of oral HHIs in the treatment of laBCC, mBCC and BCNS patients and 2) to compare the oral HHIs vismodegib and sonidegib.\n\nStudy design: prospective registration study that includes all patients, regardless of age and gender, with histologically proven basal cell carcinoma receiving treatment with either vismodegib or sonidegib in the Netherlands. Patient, tumor and treatment information was gathered from patient records.\n\nMain study parameters\u002Fendpoints: The primary outcome for measuring efficacy\u002Ftumor response was median progression free survival (PFS) where the decrease, stagnation or increase in tumor size is measured by maximum diameter. Secondary outcomes are frequency, severity and reversibility of treatment-emergent adverse events and disease-specific quality of life expressed as mean scores on the EORTC-QLQ-C30 and aBCCdex questionnaires.",[24,25,26,27,28,29,30,31,32,33,34],"Basal Cell Carcinoma","Locally Advanced Basal Cell Carcinoma","Metastatic Basal Cell Carcinoma","Gorlin Syndrome","Basal Cell Nevus Syndrome","Carcinoma, Basal Cell","Carcinoma","Basal Cell Tumor","Skin Cancer","Neoplasm of Skin","Neoplasms, Basal Cell",[36,37,38,39,40],"Oral hedgehog inhibitors","Vismodegib","Sonidegib","Erivedge","Odomzo","RECRUITING","2025-04-02",{"date":44,"type":45},"2025-04-04","ACTUAL",{"date":47,"type":45},"2021-11-01",{"date":49,"type":19},"2026-12",{"name":51,"class":52},"Maastricht University Medical Center","OTHER",8,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":16,"minAge":62,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":82},"100512705","phase-3-nicotinamide-chemoprevention-for-keratinocyte-carcinoma-in-solid-organ-transplant-recipients---pivotal-trial-100512705","NCT05955924","Nicotinamide Chemoprevention for Keratinocyte Carcinoma in Solid Organ Transplant Recipients - Pivotal Trial","Nicotinamide Chemoprevention for Keratinocyte Carcinoma in Solid Organ Transplant Recipients: a Multicentre, Pragmatic Randomized Trial","SPRINTR","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Kidney, liver, heart, or lung transplant at least two years ago\n* History of at least one prior histologically-confirmed keratinocyte carcinoma or squamous cell carcinoma in situ\n* Currently immunosuppressed with a calcineurin inhibitor-based regimen (cyclosporine or tacrolimus)\n* Able to attend follow-up visits\n\nExclusion Criteria:\n\n* Use of nicotinamide or niacin (≥250 mg daily) within past 12 weeks\n* Untreated localized skin cancer at baseline (patient can enrol after skin cancer treatment)\n* Biopsy-confirmed acute rejection episode within the past 12 weeks\n* Active liver disease (high AST \\>3 times or bilirubin \\>1.5 times)\n* Severe kidney disease (estimated glomerular filtration rate \\\u003C20 mL\u002Fmin\u002F1.73 m2)\n* Solid organ or hematologic malignancy, invasive melanoma, Merkel cell carcinoma, or metastatic skin cancer within the past five years\n* Pregnancy or lactation\n* Need for ongoing carbamazepine or primidone\n* Allergy to nicotinamide or any ingredient of the vitamin or placebo capsules","18 Years",{"count":64,"type":19},396,"INTERVENTIONAL",[67],"PHASE3","As patients live longer after receiving an organ transplant, there is a need to reduce the long-term side effects of the drugs used to prevent organ rejection. In particular, long-term use of these drugs increases the risk of skin cancer. Skin cancer is now a leading cause of illness and disfigurement after kidney, liver, heart, and lung transplantation. Given the increased risk and burden of skin cancer in transplant recipients, prevention is critical.\n\nNicotinamide is a form of Vitamin B3 that has been shown to protect against skin cancer in the general population. However, it is unclear whether nicotinamide is effective among immune-suppressed transplant recipients. Investigators will conduct a clinical trial involving multiple transplant centres in Canada to evaluate whether oral nicotinamide (500 mg twice daily) is effective and safe for preventing skin cancer. Investigators will recruit 396 high-risk adult kidney, liver, heart, and lung transplant patients who have previously had at least one skin cancer. Patients will receive nicotinamide or sham tablets for up to 4 years. The results will inform efforts to improve the long-term health of transplant recipients.",[70,71,29,72],"Non-melanoma Skin Cancer","Carcinoma, Squamous Cell","Keratinocyte Carcinoma","2025-02-20",{"date":75,"type":45},"2025-02-21",{"date":77,"type":45},"2023-08-28",{"date":79,"type":19},"2027-08",{"name":81,"class":52},"Women's College Hospital",7]