Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2026-02-28 @ 7:10 PM
Study NCT ID:
NCT02829112
Status:
UNKNOWN
Last Update Posted:
2017-04-27
First Post:
2016-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Shulman Fasciitis Prevalence Study in Alsace
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005208', 'term': 'Fasciitis'}, {'id': 'C562487', 'term': 'Eosinophilic Fasciitis'}], 'ancestors': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-25', 'studyFirstSubmitDate': '2016-06-16', 'studyFirstSubmitQcDate': '2016-07-07', 'lastUpdatePostDateStruct': {'date': '2017-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimation of the prevalence of Shulman fasciitis in Alsace, the calculation will be carried out using the numerator of all the cases identified and in the denominator the general population (Alsatian population of both sexes)', 'timeFrame': 'all living patients in Alsace from 1 January 2016 to december 2016'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Shulman', 'fasciitis', 'Shulman fasciitis', 'eosinophilic fasciitis', 'inflammatory disease', 'prevalence'], 'conditions': ['Shulman Fasciitis']}, 'descriptionModule': {'briefSummary': 'Shulman fasciitis or eosinophilic fasciitis (EF) is a rare inflammatory disease, usually benign but disabling, described by Shulman in 1974. The diagnosis is suggested by the clinic, confirmed by MRI and confirmed by histology, there really no published diagnostic criteria validated for this rare disease. The low number of cases reported in the literature reflects the difficulty of studying the epidemiology of this disease, to establish and evaluate therapeutic strategies and to assess prognosis. Work on this subject are few. To our knowledge, no study has previously used to estimate the incidence and prevalence of this disease. Therefore, the investigators want to determine the prevalence of FEs in Alsace in 2016 by a study "capture-recapture" using several independent sources of identification of cases in order to have recent epidemiological data and learn more about this disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients suffering from fasciitis Shulmande and living in Alsace at 1 January 2016', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged over 18 years\n* Patients suffering from fasciitis Shulmande and living in Alsace at 1 January 2016\n\nExclusion Criteria:\n\n* refusal to participate in the study'}, 'identificationModule': {'nctId': 'NCT02829112', 'acronym': 'SHULMAN', 'briefTitle': 'Shulman Fasciitis Prevalence Study in Alsace', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Shulman Fasciitis Prevalence Study in Alsace', 'orgStudyIdInfo': {'id': '6177'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean SIBILIA, MD, PhD', 'role': 'CONTACT', 'email': 'jean.sibilia@chru-strasbourg.fr', 'phone': '03 88 12 79 54'}, {'name': 'Lionel Spielmann, MD', 'role': 'CONTACT', 'email': 'lionel535@hotmail.com', 'phone': '03 88 12 79 54'}, {'name': 'Mickael Schaeffer', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jean-François Kleinmann', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Service de rhumatologie, Les Hôpitaux Universitaires de Strasbourg, Centre national de référence " des maladies auto-immunes rares "', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Jean SIBILIA, MD, PhD', 'role': 'CONTACT', 'email': 'jean.sibilia@chru-strasbourg.fr', 'phone': '33 (0)3 88 12 79 54'}, {'name': 'Lionel Spielmann, MD', 'role': 'CONTACT', 'email': 'lionel.spielmann@chru-strasbourg.fr', 'phone': '33 (0)3 88 12 79 54'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}