Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-01-25 @ 5:52 AM
Study NCT ID:
NCT03114267
Status:
COMPLETED
Last Update Posted:
2017-04-14
First Post:
2017-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Involvement of Viral Infections in the Pathogenesis of Chronic Lymphocytic Thyroiditis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D050031', 'term': 'Hashimoto Disease'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D013967', 'term': 'Thyroiditis, Autoimmune'}, {'id': 'D013966', 'term': 'Thyroiditis'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2015-01-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-11', 'studyFirstSubmitDate': '2017-04-11', 'studyFirstSubmitQcDate': '2017-04-11', 'lastUpdatePostDateStruct': {'date': '2017-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-01-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analysis of the viral genome by PCR carried out in the Virology department, Analysis of the presence of capsid protein', 'timeFrame': '1 day'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Autoimmune Diseases', 'Chronic Lymphocytic Thyroiditis']}, 'descriptionModule': {'briefSummary': 'Autoimmune diseases represent a heterogeneous group of pathologies whose etiopathogenic mechanisms are most often unknown. Autoimmune diseases are the leading cause of morbidity and mortality in young women and autoimmune thyroid diseases are the most common.\n\nViral infections are the main environmental factors suspected of triggering autoimmune diseases. Several viruses are certainly involved, all of which are possibly capable of triggering an autoimmune response. However, the precise identification of the viruses involved remains to be established.\n\nIt has been shown for the first time by the 2005 PHRC that enteroviral RNA is present in perioperative specimens of thyroid tissue. However, this case-control study did not show any difference between the thyroid group and the group other thyroid pathologies It has been recently published that Parvovirus is possibly involved in thyroiditis: the parvoviral genome is present in the thyroid tissue of Hashimoto thyroiditis operated and more precisely is present within the thyrocytes itself.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients were recruited after PHRC 2005. Written information for the extension of the study will be sent with a copy of the summary of the scientific publication on Enterovirus (PHRC 2005).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients participating in PHRC 2005 "involvement of enteroviruses in TLC pathogenesis"\n* Inclusion of TLC: presence of a significant lymphocyte infiltrate within the thyroid parenchyma defined by the presence of clusters of more than 30 to 50 lymphocytes\n* Inclusion of controls: absence of significant lymphocyte infiltrate\n\nExclusion Criteria:\n\n* Persons refusing to participate in research'}, 'identificationModule': {'nctId': 'NCT03114267', 'acronym': 'Etude thyrovir', 'briefTitle': 'Involvement of Viral Infections in the Pathogenesis of Chronic Lymphocytic Thyroiditis', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Involvement of Viral Infections in the Pathogenesis of Chronic Lymphocytic Thyroiditis', 'orgStudyIdInfo': {'id': 'PI11-PR-DESAILLOUD-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient with chronic lymphocytic thyroiditis', 'interventionNames': ['Other: Comparison of the prevalences of the parvovirus genome']}, {'label': 'Healthy subjects', 'interventionNames': ['Other: Comparison of the prevalences of the parvovirus genome']}], 'interventions': [{'name': 'Comparison of the prevalences of the parvovirus genome', 'type': 'OTHER', 'description': 'Comparison of the prevalences of the parvovirus genome between cases and controls and then of other viruses according to the results of parvoviruses and data from the literature', 'armGroupLabels': ['Healthy subjects', 'Patient with chronic lymphocytic thyroiditis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'state': 'Picardie', 'country': 'France', 'facility': 'CHU Amiens Picardie', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}