Ignite Creation Date:
2025-12-25 @ 2:25 AM
Ignite Modification Date:
2025-12-28 @ 12:04 AM
Study NCT ID:
NCT06807034
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-04
First Post:
2025-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of the Oral Microbiota on Relapse in HNSCC Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-01-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-31', 'studyFirstSubmitDate': '2025-01-20', 'studyFirstSubmitQcDate': '2025-01-31', 'lastUpdatePostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Microbiota', 'timeFrame': '2 years', 'description': 'Analysis of buccal microbiota by 16SrRNA gene sequencing'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': 'to characterise the impact of microbiota in radiotherapy efficacy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* head and neck cancer\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06807034', 'acronym': 'MICR-ORL', 'briefTitle': 'Impact of the Oral Microbiota on Relapse in HNSCC Patients', 'organization': {'class': 'OTHER', 'fullName': 'Institut Sainte Catherine'}, 'officialTitle': 'Impact of the Oral Microbiota on Relapse in HNSCC Patients', 'orgStudyIdInfo': {'id': 'MICR-ORL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'buccal swabs', 'description': 'buccal swabs for microbiota analysis before and after treatment', 'interventionNames': ['Other: buccal swabs']}], 'interventions': [{'name': 'buccal swabs', 'type': 'OTHER', 'description': 'buccal swabs for microbiota analysis before and after radiotherapy', 'armGroupLabels': ['buccal swabs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84918', 'city': 'Avignon', 'country': 'France', 'facility': 'ICAP', 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Sainte Catherine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}