Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-02-22 @ 7:08 PM
Study NCT ID:
NCT06113094
Status:
UNKNOWN
Last Update Posted:
2023-11-02
First Post:
2022-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cryoablation for Advanced and Refractory Desmoid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018222', 'term': 'Desmoid Tumors'}, {'id': 'D005350', 'term': 'Fibroma'}], 'ancestors': [{'id': 'D018218', 'term': 'Neoplasms, Fibrous Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-30', 'studyFirstSubmitDate': '2022-11-14', 'studyFirstSubmitQcDate': '2023-10-30', 'lastUpdatePostDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival assessed using RECIST(Response evaluation criteria in solid tumors) criteria', 'timeFrame': 'at 6 months after cryoablation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Desmoid tumors', 'Fibromatosis', 'Invasive tumors', 'Radiotherapy', 'Cryoablation'], 'conditions': ['Desmoid Tumors']}, 'descriptionModule': {'briefSummary': 'Desmoid tumors, also called aggressive fibromatosis, are rare, locally invasive tumors with no potential for metastasis. The incidence is approximately 2 to 4 per million per year in the general population. The "watch and wait" policy is the standard of care for newly diagnosed patients in Europe. Patients who progress have first-line medical treatment, surgery is no longer the treatment because there is a high rate of recurrence (\\> 60%) and radiotherapy is not very suitable because the patients are often young and the tumors are large. Cryoablation seems to be an effective therapeutic option that should be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patient (≥18 years old) having undergone cryoablation for an advanced desmoid tumor refractory to medical treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Adult patient (≥18 years old)\n* Having undergone cryoablation for an advanced desmoid tumor refractory to medical treatment\n* Having not expressed their opposition, after being informed, to the reuse of their data for the purposes of this research.\n\nExclusion criteria:\n\n* Subject who expressed their opposition to participating in the study\n* Patient already included in another ongoing study\n* Subject under guardianship or curatorship\n* Subject under safeguard of justice'}, 'identificationModule': {'nctId': 'NCT06113094', 'acronym': 'CARDT', 'briefTitle': 'Cryoablation for Advanced and Refractory Desmoid Tumors', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Cryoablation for Advanced and Refractory Desmoid Tumors', 'orgStudyIdInfo': {'id': '7884'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pierre AULOGE, MD', 'role': 'CONTACT', 'email': 'pierre.auloge@chru-strasbourg.fr', 'phone': '33 3 69 55 15 26'}, {'name': 'Pierre AULOGE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Afshin GANGI, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Roberto Luigi CAZZATO, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Julien GARNON, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'François SEVERAC, Statistician', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Service d'Imagerie Interventionnelle - CHU de Strasbourg - France", 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Pierre AULOGE, MD', 'role': 'CONTACT', 'email': 'pierre.auloge@chru-strasbourg.fr', 'phone': '33 3 69 55 15 26'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}