Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2025-12-31 @ 6:16 PM
Study NCT ID:
NCT05103969
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2021-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cohort of Tumors With POLE/D1 Mutation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blocks of tumor removed in the course of care fixed tissue.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-05', 'studyFirstSubmitDate': '2021-10-06', 'studyFirstSubmitQcDate': '2021-10-22', 'lastUpdatePostDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To identify and describe the clinico-biological and molecular characteristics of tumors with somatic POLE/POLD1 mutation identified by molecular biology platforms for all stages and primary sites', 'timeFrame': 'October 2027', 'description': 'Collection and description of clinical and histo-pathological data of tumors with POLE/POLD1 mutation'}, {'measure': 'Molecular characterization of the identified POLE/POLD1 mutations', 'timeFrame': 'October 2027', 'description': 'Molecular characterization of the identified POLE/POLD1 mutations and of the mutational profile associated with these mutations'}, {'measure': 'Overall survival and response to treatments', 'timeFrame': 'October 2027', 'description': 'Analysis of overall survival and response to treatments (chemotherapies, immunotherapies...)'}], 'secondaryOutcomes': [{'measure': 'database and block librabry', 'timeFrame': 'October 2027', 'description': 'Establishment of a database of somatic POLE variants Establishment of a block library of POLE mutated tumors'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tumors', 'POLE Exonuclease Domain Mutation', 'POLD1 Gene Mutation']}, 'descriptionModule': {'briefSummary': 'Primary objective of this study is to identify and describe the clinico-biological and molecular characteristics of tumors with somatic POLE (Polymerase ɛ)/POLD1 mutation identified by molecular biology platforms for all stages and primary sites combined', 'detailedDescription': 'The identification of patients to be included will be done directly from the tumor genotyping platforms.\n\nIndeed, they will be the direct source of the identification of all POLE (Polymerase ɛ) mutations.\n\nThe platforms will inform the project coordination unit of new cases of mutated cancers as well as the referent investigator, jointly they will be in charge of data entry.\n\nThe diagnostic and follow-up data of each patient will be collected prospectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '\\- Patient with a histologically proven tumor with a POLE or POLD1 mutation identified by molecular biology analysis, carried out within the framework of clinical practice in the platforms that have set up this research.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any tumor presenting a variant of the exonuclease domain of POLE (exons 9 to 14) classified as pathogenic by the project working group, including: the 4 hotspots of mutations described (codons 286 (P286R/H/L), 411 (V411L), 459 (S459F), 424 (L424/V/I), (2).\n* Any tumor presenting a variant of the exonuclease domain of PolD1 (exons 8-12), classified as pathogenic by the project working group, including : C319Y(10).\n\nDiagnosis made from the date of launch of the cohort and in the previous year\n\n-Age ≥ 18 years\n\nExclusion Criteria:\n\n* Tumor without POLE or POLD1 mutation\n* Tumor with POLE mutation identified in research studies retrospective research\n* Opposition of the patient to the registration of his data in the cohort'}, 'identificationModule': {'nctId': 'NCT05103969', 'briefTitle': 'Cohort of Tumors With POLE/D1 Mutation', 'organization': {'class': 'OTHER', 'fullName': 'Federation Francophone de Cancerologie Digestive'}, 'officialTitle': 'Multicenter Prospective Cohort of Tumors With Pole/D1 Mutation', 'orgStudyIdInfo': {'id': 'POLE COHORT'}}, 'contactsLocationsModule': {'locations': [{'zip': '31059', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Rosine GUIMBAUD, PhD MD', 'role': 'CONTACT', 'email': 'guimbaud.r@chu-toulouse.fr', 'phone': '+33 (0)5 61 32 21 42'}], 'facility': 'CHU -hopital Rangeuil', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'ROSINE GUIMBAUD, PhD.MD', 'role': 'CONTACT', 'email': 'guimbaud.r@chu-toulouse.fr', 'phone': '+33 (0)5 61 32 21 42'}], 'overallOfficials': [{'name': 'Rosine GUIMBAUD, PhD.MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fédération francophone de Cancérologie digestive'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federation Francophone de Cancerologie Digestive', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}