Ignite Creation Date:
2025-12-24 @ 12:13 PM
Ignite Modification Date:
2026-01-16 @ 8:51 PM
Study NCT ID:
NCT07242261
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-21
First Post:
2025-11-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-invasive Characterisation of Oral Carcinomas in Patients With Fanconi Anaemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003554', 'term': 'Cystinosis'}], 'ancestors': [{'id': 'D016464', 'term': 'Lysosomal Storage Diseases'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014099', 'term': 'Toothbrushing'}], 'ancestors': [{'id': 'D009910', 'term': 'Oral Hygiene'}, {'id': 'D011313', 'term': 'Preventive Dentistry'}, {'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 115}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2030-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2025-11-17', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oral brushing', 'timeFrame': 'Day 0', 'description': '* "Positive" result: presence of dysplastic cells at the moderate dysplasia stage or malignant cells.\n* "Negative" result: absence of dysplastic cells beyond the mild dysplasia stage and absence of malignant cells.'}], 'secondaryOutcomes': [{'measure': 'oral lesion biopsy', 'timeFrame': 'Day 0', 'description': '* "Positive" result: presence of dysplastic cells at the moderate dysplasia stage or malignant cells.\n* "Negative" result: absence of dysplastic cells beyond the mild dysplasia stage and absence of malignant cells.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fanconi anaemia', 'oral brushing', 'head and neck carcinoma'], 'conditions': ['Fanconi Anaemia']}, 'descriptionModule': {'briefSummary': 'Patients with Fanconi anaemia have an increased risk of developing squamous cell carcinoma of the head and neck. In addition, their genetic vulnerability limits the use of genotoxic treatments such as radiotherapy and chemotherapy, due to increased exposure to severe toxicities.\n\nLess invasive diagnostic techniques, such as brush biopsies, which rely on cytological and ploidy analysis, offer the possibility of more systematic, comprehensive and less painful oral mapping, thereby facilitating earlier diagnosis.', 'detailedDescription': 'The aim of the study is to investigate the capabilities of oral brushing for the characterisation of oral lesions in patients with Fanconi anaemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* have Fanconi anaemia\n* are aged 15 years or older\n* have at least one oral lesion with or without warning signs\n* who agree to participate in the study\n\nExclusion Criteria:\n\n* pregnant and breastfeeding women\n* protected by law (guardianship, curatorship, judicial protection)\n* refusing to participate in the study'}, 'identificationModule': {'nctId': 'NCT07242261', 'acronym': 'Fanc-Oral', 'briefTitle': 'Non-invasive Characterisation of Oral Carcinomas in Patients With Fanconi Anaemia', 'organization': {'class': 'OTHER', 'fullName': 'Institut Jean-Godinot'}, 'officialTitle': 'Non-invasive Characterisation of Oral Carcinomas in Patients With Fanconi Anaemia', 'orgStudyIdInfo': {'id': '2025_RIPH_04_Fanc-Oral'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with Fanconi anaemia', 'interventionNames': ['Other: Oral brushing']}], 'interventions': [{'name': 'Oral brushing', 'type': 'OTHER', 'description': 'oral brushing of all oral lesions', 'armGroupLabels': ['Patients with Fanconi anaemia']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Barbe / Coralie, DR', 'role': 'CONTACT', 'email': 'currs@univ-reims.fr', 'phone': '03 26 91 36 65', 'phoneExt': '+33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Jean-Godinot', 'class': 'OTHER'}, 'collaborators': [{'name': 'Université de Reims Champagne-Ardenne', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}