Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2026-01-18 @ 3:23 PM
Study NCT ID:
NCT03738267
Status:
SUSPENDED
Last Update Posted:
2025-09-26
First Post:
2018-11-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on the Occurrence of Head and Neck Cancers During Pregnancy
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'number of inclusions not reached', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2018-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2018-11-06', 'studyFirstSubmitQcDate': '2018-11-09', 'lastUpdatePostDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serological status of patients', 'timeFrame': 'Through study completion, an average of 5 years', 'description': 'Number of patients with positive or negative serological status for PVH (Papilloma Virus Humain) and EBV (Epstein-Barr Virus)'}, {'measure': 'Characteristics pregnancy of patients', 'timeFrame': 'Through study completion, an average of 5 years', 'description': 'Presence or absence of maternal-fetal diseases'}, {'measure': 'Tumor characteristics of patients', 'timeFrame': 'Through study completion, an average of 5 years', 'description': 'Histological type of cancer'}, {'measure': 'Tumor characteristics of patients', 'timeFrame': 'Through study completion, an average of 5 years', 'description': 'Localization of cancer'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Head and Neck Cancer', 'Pregnancy Related']}, 'descriptionModule': {'briefSummary': 'Head and neck cancers that occurred during pregnancy'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with cancers of Head and Neck that occurred during pregnancy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 year old woman or over at the time of participation\n* PS 0 -2\n* Cancer diagnosed (biopsy date) from 01/01/2010 between the second week of pregnancy and the 12 months postpartum.\n* Primitive may concern the following sites:\n\noral cavity, nasopharynx, oropharynx, hypopharynx, larynx, prevalent lymphadenopathy, nasal cavity, salivary glands, dental tumors, ear tumors, paragangliomas optic pathways, facial sinus / facial mass, nose, ear and other head and neck\n\n* All histologies (epithelial tumors, sarcomas, mucosal melanomas, embryonic tumors, undifferentiated tumors)\n* Patient receiving or having received a specific oncological treatment among surgery, radiotherapy, chemotherapy, hormone therapy.\n* All stages allowed: localized stages and metastatic stages immediately.\n* No opposition of the patient to participate in this study\n\nExclusion Criteria:\n\n* Any other neoplastic antecedent\n* Exclusion of metastases at the level of the VADS of another primitive than a cancer of the VADS\n* Exclusion of hematological tumors (lymphoma) and glial tumors\n* Person subject to a legal protection measure or unable to express their consent'}, 'identificationModule': {'nctId': 'NCT03738267', 'acronym': 'REFCORbirth', 'briefTitle': 'Study on the Occurrence of Head and Neck Cancers During Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Centre Francois Baclesse'}, 'officialTitle': 'Study on the Occurrence of Head and Neck Cancers During Pregnancy', 'orgStudyIdInfo': {'id': '2018-A01220-55'}}, 'contactsLocationsModule': {'locations': [{'city': 'Besançon', 'country': 'France', 'facility': 'Chu Besancon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'city': 'Bordeaux', 'country': 'France', 'facility': 'Chu Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Caen', 'country': 'France', 'facility': 'Centre François Baclesse', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Grenoble', 'country': 'France', 'facility': 'Chu Grenoble Alpes', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Paris', 'country': 'France', 'facility': 'Ap-Hp Tenon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Poitiers', 'country': 'France', 'facility': 'Chu Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'Chu Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Villejuif', 'country': 'France', 'facility': 'Institut Gustave Roussy IGR', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Francois Baclesse', 'class': 'OTHER'}, 'collaborators': [{'name': 'French scientific group REFCOR', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}