Ignite Creation Date:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2026-02-18 @ 12:31 AM
Study NCT ID:
NCT03662828
Status:
UNKNOWN
Last Update Posted:
2019-05-14
First Post:
2018-07-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidemiological Description of the Kaposi's Disease in France's Southeast
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014983', 'term': 'Xeroderma Pigmentosum'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012868', 'term': 'Skin Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D010787', 'term': 'Photosensitivity Disorders'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D049914', 'term': 'DNA Repair-Deficiency Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-13', 'studyFirstSubmitDate': '2018-07-23', 'studyFirstSubmitQcDate': '2018-09-05', 'lastUpdatePostDateStruct': {'date': '2019-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Prevalence of Kaposi's disease", 'timeFrame': '10 years (2007-2017)', 'description': "Diagnosed patients with biopsy, in France's southeast"}], 'secondaryOutcomes': [{'measure': "Descriptive analysis of the different form of the Kaposi's disease in the population", 'timeFrame': '10 years (2007-2017)', 'description': 'Mediterranean form, endemic form, iatrogenic form and epidemic form'}, {'measure': 'Descriptive analysis of the population : sociodemographic', 'timeFrame': '10 years (2007-2017)', 'description': 'sociodemographic characteristics'}, {'measure': 'Descriptive analysis of the population : paraclinical', 'timeFrame': '10 years (2007-2017)', 'description': 'paraclinical characteristics'}, {'measure': 'Descriptive analysis of the population : clinical', 'timeFrame': '10 years (2007-2017)', 'description': 'clinical characteristics'}, {'measure': 'Descriptive analysis of the population : therapeutic', 'timeFrame': '10 years (2007-2017)', 'description': 'therapeutic care'}, {'measure': 'Survival analysis', 'timeFrame': '10 years (2007-2017)', 'description': 'mortality rate'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Kaposi's disease", 'HHV8', 'Prevalence'], 'conditions': ["Kaposi's Disease"]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate the prevalence of the Kaposi's disease in France's southeast on 10 years (from 2007 to 2017)", 'detailedDescription': "Kaposi's disease is a multifocal disease with cutaneous expression in more than 95% of cases.\n\nThere are 4 forms : Mediterranean, Endemic (Sub-Saharan Africa), iatrogenic and epidemic (HIV) The physiological hypotheses to explain the disease are not clear. A proliferation of immunity cells in blood vessels and also an undetermined role of the human herpes virus 8 (HHV-8) could be involved.\n\nThe treatment is complex and not standardized. There are a lot of different treatments.\n\nThe purpose of this study is to evaluate the prevalence and described the characteristics and the treatment of the Kaposi's disease in the France's southeast on 10 years, from 2007 to 2017."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Diagnosed patients with a Kaposi's disease by biopsy from January 2007 to December 2017", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosed patients with a Kaposi's disease by biopsy from January 2007 to December 2017\n\nExclusion Criteria:\n\n* Opposition to the use of personal data"}, 'identificationModule': {'nctId': 'NCT03662828', 'acronym': 'KAPOSI-1', 'briefTitle': "Epidemiological Description of the Kaposi's Disease in France's Southeast", 'organization': {'class': 'OTHER', 'fullName': 'Direction Centrale du Service de Santé des Armées'}, 'officialTitle': "Epidemiological Description of the Kaposi's Disease in France's Southeast", 'orgStudyIdInfo': {'id': 'KAPOSI-1'}}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Nice', 'state': 'Alpes-Maritimes', 'country': 'France', 'facility': 'Centre Antoine Lacassagne', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '06000', 'city': 'Nice', 'state': 'Alpes-Maritimes', 'country': 'France', 'facility': 'CHU Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '13384', 'city': 'Marseille', 'state': 'Bouche Du Rhone', 'country': 'France', 'facility': 'HIA Laveran', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '83600', 'city': 'Fréjus', 'state': 'Var', 'country': 'France', 'facility': 'CHI de Fréjus', 'geoPoint': {'lat': 43.43325, 'lon': 6.73555}}, {'zip': '83000', 'city': 'Toulon', 'state': 'Var', 'country': 'France', 'facility': "Hôpital d'Instruction des Armées Sainte-Anne", 'geoPoint': {'lat': 43.12442, 'lon': 5.92836}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Direction Centrale du Service de Santé des Armées', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}