[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"desmoid\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:desmoid":34},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,64,90,108,130],{"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":25,"conditions":26,"keywords":42,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":63},"100509886","phase-1-fog-001-in-locally-advanced-or-metastatic-solid-tumors-100509886",false,"NCT05919264","FOG-001 in Locally Advanced or Metastatic Solid Tumors","A Phase 1\u002F2 Study of FOG-001 in Participants With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate organ and marrow function.\n\nAdditional Inclusion Criteria for Dose Escalation Cohorts (Part 1a and Part 1g):\n\n* Diagnosis of treatment-refractory advanced\u002Fmetastatic solid tumor that is non-MSI-H or non-dMMR colorectal cancer (CRC) or any other solid tumor with documented WNT- pathway activating mutations (WPAMs).\n\nAdditional Inclusion Criteria for Dose Escalation Cohorts (Part 1b):\n\n* Diagnosis of treatment-refractory advanced\u002Fmetastatic non-MSI-H or non-dMMR CRC.\n* At least one lesion that is suitable for a core needle biopsy.\n\nAdditional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1c and Part 2c):\n\n* Histologically, cytologically, or radiographically confirmed HCC with a documented WPAM (by local ctDNA or tumor NGS testing) in APC or CTNNB1\n\nAdditional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1d, Part 1h, and Part 2d):\n\n* Desmoid tumor (aggressive fibromatosis)\n\nAdditional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1f-1 and Part 2f-1) FOG-001 + FOLFOX + Bevacizumab:\n\n* Diagnosis of locally advanced or metastatic non-MSI-H or non-dMMR CRC\n* Participants with tumors known to be negative for APC LoF mutations or CTNNB1 GoF mutations (per NGS tests) are not eligible.\n* One dose of mFOLFOX6 with or without bevacizumab in the unresectable or metastatic setting prior to enrollment is allowed.\n\nAdditional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1f-2 and Part 2f-2): FOG-001 + Nivolumab\n\n* Non-MSI-H or non-dMMR (by local testing) CRC with or without liver metastases.\n* MSI-H CRC or solid tumors that are WPAM and resistant to a-PD-1\u002FPD-L1\n* Participants with tumors known to be negative for APC LoF mutations or CTNNB1 GoF mutations (per NGS tests) are not eligible\n\nAdditional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1f-3 and Part 2f-3): FOG-001 + Trifluridine\u002FTipiracil + Bevacizumab\n\n* Diagnosis of locally advanced or metastatic non-MSI-H or non-dMMR (by local testing) CRC\n* Participants with tumors known to be negative for APC LoF mutations or CTNNB1 GoF mutations (per NGS tests) are not eligible.\n\nAdditional Inclusion Criteria for Dose Expansion Cohort (Part 2a):\n\n* Diagnosis of locally advanced or metastatic non-MSI-H or non-dMMR (by local testing) CRC\n\nAdditional Inclusion Criteria for Dose Expansion Cohort (Part 2b):\n\n* Diagnosis of advanced or metastatic solid tumors with a documented WPAM (by local testing) or equivalent evidence\n\nExclusion Criteria:\n\n* Known history of bone metastasis. Bone metastasis are allowed for patients with mCRPC.\n* Evidence of vertebral compression fracture or non-traumatic bone fracture within the past 12 months and who are not receiving antiresorptive therapy.\n* Osteoporosis, which is defined as a T-score of ≤-2.5 at the lumbar spine (L1 - L4), left (or right) femoral neck or left (or right) total hip as determined by DXA scan.\n* Uncontrolled inflammatory bowel disease (i.e., ulcerative colitis or Crohn's disease)\n* Unstable\u002Finadequate cardiac function.\n* Has known meningeal carcinomatosis, leptomeningeal carcinomatosis, spinal cord compression, or symptomatic or unstable brain metastases.\n* Pregnant, lactating, or planning to become pregnant.","ALL","18 Years",{"count":19,"type":20},595,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The goal of this clinical trial is to determine if FOG-001 is safe and effective in participants with locally advanced or metastatic solid tumors.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41],"Cancer","Colorectal Cancer","Solid Tumor","Locally Advanced Solid Tumor","Metastatic Cancer","WNT Pathway","HCC","Desmoid","Microsatellite Stable Colorectal Cancer","Metastatic Castration-resistant Prostate Cancer","FAP","Endometrial Carcinoma","Prostate Cancer","Microsatellite Instability-High Colorectal Cancer","Adamantinomatous Craniopharyngioma",[27,29,30,31,43,44,45,34,46,47,48,49,50],"WNT Pathway Activating Mutation (WPAM)","Colorectal Cancer (CRC)","Microsatellite Stable (MSS)","Hepatocellular Carcinoma (HCC)","Adenomatous Polyposis Coli (APC)","β-catenin","Beta-catenin","CTNNB1","RECRUITING","2026-05-26",{"date":54,"type":55},"2026-05-28","ACTUAL",{"date":57,"type":55},"2023-05-23",{"date":59,"type":20},"2027-08-31",{"name":61,"class":62},"Parabilis Medicines, Inc.","INDUSTRY",33,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":74,"phases":4,"briefSummary":75,"conditions":76,"keywords":77,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":89},"100536717","arterial-chemoembolization-for-the-treatment-of-desmoid-fibromatosis-100536717","NCT06268457","Arterial Chemoembolization for the Treatment of Desmoid Fibromatosis","Chemioembolizzazione Arteriosa Per il Trattamento Della Fibromatosi Desmoide: Studio Osservazionale Prospettico","Embodesmo","Inclusion Criteria:\n\n* FIbromatosis demsoid symptomatic and in active phase (documented growth at last follow-ups)\n* Patients who are not candidates for surgery or cryoablation\n\nExclusion Criteria:\n\n* Patients with life expectancy \\\u003C3 months or severely impaired status functional status (ASA 4)\n* Patients with fibromatosis not in active phase, documented clinically and by investigations imaging (MRI, CT)\n* Patients with coagulation deficiency or plateletopenic disease\n* Patients with documented active infection",{"count":73,"type":20},20,"OBSERVATIONAL","Desmoid fibromatoses are rare (1-2 cases\u002Fmillion per year) and locally aggressive mesenchymal tumors. For asymptomatic disease, current guidelines suggest an initial period of active surveillance.\n\nThe current scientific evidence regarding the efficacy and safety of the treatment of desmoid fibromatosis by arterial embolization is constituted by several retrospective and prospective studies. Embolization of desmoid tumors alone, without chemotherapy, on the contrary, has been shown to be inefficient. Using Doxorubicin in desmoid fibromatosis is effective but associated with systemic toxicity. Consequently, this drug is reserved for symptomatic, nonresponsive, rapidly growing or life-threatening tumors. The intrinsic hypervascularity of desmoid tissue can be exploited as a conduit to achieve local distribution of Doxorubicin by navigation of a catheter endovascular.",[34],[78],"Chemoembolization","2026-05-11",{"date":81,"type":55},"2026-05-14",{"date":83,"type":55},"2024-02-20",{"date":85,"type":20},"2028-02-01",{"name":87,"class":88},"Istituto Ortopedico Rizzoli","OTHER",1,{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":74,"phases":4,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":105,"leadSponsor":107,"locationsCount":89},"100533320","radiomics-compared-with-conventional-response-criteria-for-predicting-progression-of-desmoid-tumor-after-cryoablation-100533320","NCT06224283","Radiomics Compared With Conventional Response Criteria for Predicting Progression of Desmoid Tumor After Cryoablation","Confronto Tra Radiomica e i Criteri Convenzionali di Risposta Nella Previsione Della Progressione Del Tumore Desmoide Dopo Crioablazione","Cryomics","Inclusion Criteria:\n\n* desmoid tumor treated at Rizzoli Orthopaedic Institute with cryoablation\n* baseline MRI\n* clinical and radiologic follow-up until disease progression or the start of a new line of treatment performed every 3 months, with a minimum of 6 months follow-up\n\nExclusion Criteria:\n\n\\- not meeting inclusion criteria",{"count":99,"type":20},21,"Desmoid tumors (DT) are uncommon tumors that arise from musculoaponeurotic structures. Despite benign, they can cause pain and disability due to their tendency to be locally aggressive. Cryoablation, a technique used in interventional radiology, has gained popularity in recent years as a treatment option for sporadic DT. This involves repeated cycles of freezing, leading to cell death. Recent studies showed that percutaneous image-guided cryoablation appears to be safe and effective for local control for patients with extra-abdominal desmoid tumors.Although changes in the heterogeneity of tumors are commonly known, they are often ignored in response criteria that only evaluate tumor size in a single dimension, such as Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Nevertheless, MRI can reveal early changes in tumor heterogeneity in responding tumors, resulting from a reduction in cellular area and an increase in fibro-necrotic content, before any dimensional changes occur. These changes in heterogeneity can be quantified using a radiomics approach. The aim of this study is to develop radiomics response criteria dedicated to the evaluation of DT treated with cryoablation as a first line treatment and to compare their performance with those of alternative radiologic response criteria for predicting progression according to RECIST 1.1.",[34],{"date":103,"type":55},"2026-05-12",{"date":83,"type":55},{"date":106,"type":20},"2026-10-31",{"name":87,"class":88},{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":21,"phases":116,"briefSummary":118,"conditions":119,"keywords":120,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":89},"100446270","cryotherapy-in-the-treatment-of-desmoid-tumors-100446270","NCT05091255","Cryotherapy in the Treatment of Desmoid Tumors","Inclusion Criteria:\n\n* histologic diagnosis of desmoid tumors\n* age \\> 18 years\n* abdominal and extra-abdominal desmoid tumors\n\nExclusion Criteria:\n\n* contraindication to the procedure by the interventional radiologist in terms of tumor proximity to neurologic\u002Fvascular structures\n* retroperitoneal desmoid tumors\n* age \\\u003C 18 years",{"count":115,"type":20},94,[117],"NA","Desmoid tumor is a benign neoplasm with an unpredictable course and a high rate of local recurrence if treated surgically. Therefore, over time the surgical approach has become conservative, preferring simple observation or medical therapy in case of disease progression through the use of hormonal therapy and low-dose chemotherapy. Since this neoplasm remains benign, our study aims to avoid chemotherapy in patients usually young through the use of a minimally invasive treatment such as cryotherapy.",[34],[121],"desmoid tumor; cryotherapy","2025-07-29",{"date":124,"type":55},"2025-08-01",{"date":126,"type":55},"2021-05-20",{"date":128,"type":20},"2027-01-01",{"name":87,"class":88},{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":137,"sex":16,"minAge":17,"maxAge":138,"enrollmentInfo":139,"targetDuration":4,"studyType":21,"phases":141,"briefSummary":142,"conditions":143,"keywords":4,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":89},"100543442","a-prospective-clinical-study-on-the-safety-and-efficacy-of-radiofrequency-ablation-for-the-treatment-of-patients-with-desmoid-tumors-100543442","NCT06355921","A Prospective Clinical Study on the Safety and Efficacy of Radiofrequency Ablation for the Treatment of Patients With Desmoid Tumors","RFAdesmoid","Inclusion Criteria:\n\n1. Patients with histologically verified diagnosis of dermoid tumor\n2. The presence of progressive, symptomatic or functionally significant DF.\n3. Written Informed consent to participate in the study\n4. Age from 18 to 75 years\n5. The functional status of the patient according to the ECOG 0-2 scale\n6. Normal renal function (estimated creatinine clearance 60 ml\u002Fmin);\n7. Normal level of bilirubin and liver enzymes (AST, ALT - no more than 3 norms);\n8. Left ventricular ejection fraction \\> 55%\n9. Satisfactory bone marrow function (hemoglobin level 9 g\u002Fdl, neutrophil count 1.5 thousand\u002Fml, platelet count \\< 100 thousand\u002Fml);\n\nExclusion Criteria:\n\n1. The inability to obtain informed consent to participate in the study\n2. Synchronous or metachronous cancer\n3. Clinically significant diseases of the cardiovascular system\n4. Clinically significant CNS diseases\n5. Previous grade 2 polyneuropathy and above\n6. Current infection or other severe or systemic disease that increases the risk of complications of therapy\n7. Pregnancy, lactation",true,"75 Years",{"count":140,"type":20},27,[117],"This is a prospective study on the safety and effectiveness of radiofrequency ablation in patients with desmoid tumors.\n\nIn the study group, all patients after radiofrequency ablation of the tumor after 1 month will be evaluated using MRI and CT studies and, if solid components of the tumor are detected, repeated surgical treatment is performed followed by active monitoring after 1 month.\n\nIn the absence of a solid component, the effect is estimated by the volume of the necrotic process and monitored in dynamics every 3 months.",[144,145,34],"Desmoid Tumor","Desmoid Fibromatosis","NOT_YET_RECRUITING","2024-04-03",{"date":149,"type":55},"2024-04-10",{"date":151,"type":20},"2024-04-01",{"date":153,"type":20},"2028-05-01",{"name":155,"class":88},"Blokhin's Russian Cancer Research Center"]