Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-26 @ 2:05 AM
Study NCT ID:
NCT05617105
Status:
UNKNOWN
Last Update Posted:
2022-11-15
First Post:
2022-11-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Molecular Characterization of Perivascular Epithelioid Cell Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054973', 'term': 'Perivascular Epithelioid Cell Neoplasms'}, {'id': 'D018207', 'term': 'Angiomyolipoma'}, {'id': 'D018192', 'term': 'Lymphangioleiomyomatosis'}], 'ancestors': [{'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018205', 'term': 'Neoplasms, Adipose Tissue'}, {'id': 'D008203', 'term': 'Lymphangiomyoma'}, {'id': 'D018190', 'term': 'Neoplasm, Lymphatic Tissue'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-07', 'studyFirstSubmitDate': '2022-11-07', 'studyFirstSubmitQcDate': '2022-11-07', 'lastUpdatePostDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To retrospectively describe the percentage of tumors with FISH (Fluorescence In Situ Hybridization) identification of the TFE3 rearrangement out of 100 cases of PEComas diagnosed in France between 01 January 1990 and 15 September 2019', 'timeFrame': 'Files analysed retrospectively from January 01, 1990 to September 15, 2019 will be examined'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Perivascular epithelioid cell tumors', 'PEComas', 'Myomelanocytic markers', 'Angiomyolipomas', 'Lymphangioleiomyomatoses', 'Visceral tumors', 'Fluorescence In Situ Hybridization'], 'conditions': ['Perivascular Epithelioid Cell Tumor, Malignant']}, 'descriptionModule': {'briefSummary': 'Perivascular epithelioid cell tumors (PEComas) are rare and are characterized by the expression of myomelanocytic markers. They are a complex family that includes angiomyolipomas, lymphangioleiomyomatoses and other soft tissue and visceral tumors. Due to the low prevalence of these tumors, the natural history is unclear; furthermore, a molecular classification integrating clinical, pathological and molecular parameters has not been described to date.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients having PEComas diagnosed in France between 01/01/1990 and 15/09/2019 and reviewed by a sarcoma referral pathologist', 'eligibilityCriteria': 'Inclusion criteria:\n\n* Major patient (≥18 years)\n* Minor patient (1 to 17 years old)\n* PEComas diagnosed in France between 01/01/1990 and 15/09/2019 and reviewed by a sarcoma referral pathologist\n\nExclusion criteria :\n\n* Opposition of the patient (or the holders of parental authority) to participate in the study\n* Biological tissue from a patient who does not meet all the inclusion criteria\n* Classic triphasic angiomyolipoma or lymphangioleiomyomatosis\n* Inability to provide informed information to the subject\n* Patient under court protection\n* Patient under guardianship or curatorship'}, 'identificationModule': {'nctId': 'NCT05617105', 'acronym': 'PEComesCells', 'briefTitle': 'Molecular Characterization of Perivascular Epithelioid Cell Tumors', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Molecular Characterization of Perivascular Epithelioid Cell Tumors', 'orgStudyIdInfo': {'id': '7550'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gabriel MALOUF, MD, PhD', 'role': 'CONTACT', 'email': 'malouf.gabriel@chru-strasbourg.fr', 'phone': '33 3 88 11 51 41'}, {'name': 'Gabriel MALOUF, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Agathe Bourgmayer, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Céline Charon-Barra, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Christine Chevreau, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'François Bertucci, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Loic Chaigneau, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nelly Firmin, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'François SEVERAC, Statistician', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Youenn DAVIDSON, Statistician', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Service d'Oncologie - CHU de Strasbourg - France", 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Gabriel MALOUF, MD, PhD', 'role': 'CONTACT', 'email': 'malouf.gabriel@chru-strasbourg.fr', 'phone': '33 3 88 11 51 41'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}