Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-31 @ 5:56 AM
Study NCT ID:
NCT02180932
Status:
COMPLETED
Last Update Posted:
2015-10-26
First Post:
2014-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Towards a Viral Etiology of Periodontal Disease in Relation to Radiotherapy Treatment of Head and Neck Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010510', 'term': 'Periodontal Diseases'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'lastUpdateSubmitDate': '2015-10-23', 'studyFirstSubmitDate': '2014-05-20', 'studyFirstSubmitQcDate': '2014-07-01', 'lastUpdatePostDateStruct': {'date': '2015-10-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure of level of EBV nucleic acids', 'timeFrame': 'day 1'}, {'measure': 'Measure of level of EBV nucleic acids', 'timeFrame': 'day 180'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Periodontal Disease']}, 'descriptionModule': {'briefSummary': 'The treatment of otolaryngology (OLR) cancer is based on surgery, radiation, sometimes used in combination with chemotherapy. Patients treated with radiotherapy have multiple oral diseases: mucositis, hyposalivation, tissue fibrosis, exacerbation of periodontitis. Over 70% of patients with head and neck cancers treated with radiotherapy have a lower level of dental clinical attachment and 92% have loose teeth or missing. The management of these oral complications is a priority in OLR oncology. The aim is to improve the oral health of patients to achieve a comfortable life acceptable and necessary for healing.\n\nThis project proposes to deepen the investigation with two main objectives:\n\n1. To study in vivo the effect of radiation treatment on the evolution of the viral flora of the periodontium in a cohort of patients and matched controls.\n2. To study in vitro the effects of irradiation on the replication EBV (herpesvirus) in producing websites lymphoepithelial tonsillar, and atypical dendritic cells associated with EBV that existence were recently discovered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥ 18 years\n* Patients treated with curative radiotherapy on tumor site or surgery for cancer of the oral cavity and / or oropharynx\n* Patients naive treatments for head and neck cancers\n* Patients affiliated or beneficiary of a social security scheme\n* Patients who gave informed consent in writing\n\nExclusion Criteria:\n\n* Patients treated with neoadjuvant chemotherapy, adjuvant or concomitant\n* Patients taking immunosuppressants after organ transplantation\n* Taking anticoagulants incompatible with dental samples (possible bleeding)\n* Patients edentulous and / or whose dental condition is incompatible with the dental samples'}, 'identificationModule': {'nctId': 'NCT02180932', 'briefTitle': 'Towards a Viral Etiology of Periodontal Disease in Relation to Radiotherapy Treatment of Head and Neck Cancers', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'orgStudyIdInfo': {'id': '13-GIRCI-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'periodontal disease', 'description': 'Saliva samples', 'interventionNames': ['Biological: periodontal pocket samples']}], 'interventions': [{'name': 'periodontal pocket samples', 'type': 'BIOLOGICAL', 'armGroupLabels': ['periodontal disease']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nice', 'country': 'France', 'facility': 'Hôpital saint Roch', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}