Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-26 @ 5:42 AM
Study NCT ID:
NCT04931160
Status:
RECRUITING
Last Update Posted:
2023-04-13
First Post:
2019-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
B-dependant Rare AutoImmune diseaSES - Cohort of Patients With Suspected Diagnosis of Primitive Sjögren Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012859', 'term': "Sjogren's Syndrome"}], 'ancestors': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D014987', 'term': 'Xerostomia'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D005440', 'term': 'Fluid Therapy'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '* Sjögren patients\n* Non-Sjögren controls (retrospective)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2035-02-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-12', 'studyFirstSubmitDate': '2019-12-23', 'studyFirstSubmitQcDate': '2021-06-14', 'lastUpdatePostDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2035-02-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Description specificity of different classification criteria FOR sJOGREN (EULAR/ACR 2019, european criteria)', 'timeFrame': 'Inclusion', 'description': 'Specificity of different classification criteria, the standard gold being the diagnosis obtained by consensus of expert doctors after standardized assessment.'}], 'secondaryOutcomes': [{'measure': 'Number of patients with different manifestation including in the ESSDAI (Eular Sjögren Syndrome Disease Activity index), gold standard to measure', 'timeFrame': '10 years', 'description': 'number of patients wit arthritis of more than 6 joints, parotidomegaly, intertitial lung disease'}, {'measure': 'Number of patients with rheumatological manifestations', 'timeFrame': '10 years', 'description': 'number of patients wit arthritis of more than 6 joints, parotidomegaly, intertitial lung disease'}, {'measure': 'Number of patients with dermatological manifestations', 'timeFrame': '10 years', 'description': 'number of patients wit arthritis of more than 6 joints, parotidomegaly, intertitial lung disease'}, {'measure': 'Description diagnostic performance of new tests', 'timeFrame': '10 years', 'description': 'after evaluation of all différents test performed added to the classical items of the ACR 2017: ie ultrasound parenchymal abnormalities, sub population of B cells....'}, {'measure': 'Disease evolution criteria', 'timeFrame': '10 years', 'description': 'modification of the ESSDAI at each visit'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Sjogren's Syndrome"]}, 'descriptionModule': {'briefSummary': 'The objectif is to study the diagnosis performance of the different classification criteria in reference to the gold standard consisting of the diagnosis made by expert doctors after standardized assessment, of pSS (primary Sjogren syndrome)', 'detailedDescription': 'The formation of this patient is single-center prospective intervention. It consists of collecting data from patients suspected of pSS from standardized biological clinical data and imaging examination and additional pathology.\n\n* Sjögren patients will be followed at inclusion, 2y, 3y, 4y, 6y, 8y and 10 years. Blood, fluid, sells and urine samples will be collected at inclusion, 4y et 10y.\n* Non-Sjögren controls will be followed at inclusion and 4y and samples will be collected at the same visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Major patient\n* Suspicion of SSp (clinical or biological criteria, i.e. dry eye or oral syndrome, arthritis, parotidomegaly, neuropathy, kidney or lung disease...)\n* Patient affiliated with Social Security\n* Patient who has signed written informed consent\n\nExclusion Criteria:\n\n* Refusal to participate\n* Pregnant and lactating woman'}, 'identificationModule': {'nctId': 'NCT04931160', 'acronym': 'BRAISES-DiaPSS', 'briefTitle': 'B-dependant Rare AutoImmune diseaSES - Cohort of Patients With Suspected Diagnosis of Primitive Sjögren Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'B-dependant Rare AutoImmune diseaSES - Cohort of Patients With Suspected Diagnosis of Primitive Sjögren Syndrome', 'orgStudyIdInfo': {'id': 'BRAISE DiaPSS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sjögren patients', 'description': 'patients diagnosed Sjögren', 'interventionNames': ['Other: Blood, fluid, sells and urine samples']}, {'type': 'OTHER', 'label': 'Non-Sjögren witnesses', 'description': 'patients diagnosed no Sjögren', 'interventionNames': ['Other: Blood, fluid, sells and urine samples']}], 'interventions': [{'name': 'Blood, fluid, sells and urine samples', 'type': 'OTHER', 'description': 'Blood, fluid, sells and urine samples will be collected.', 'armGroupLabels': ['Non-Sjögren witnesses', 'Sjögren patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brest', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Valérie DEVAUCHELLE', 'role': 'CONTACT'}], 'facility': 'CHRU de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}], 'centralContacts': [{'name': 'Valérie Devauchelle, MD,PhD', 'role': 'CONTACT', 'email': 'valerie.devauchelle-pensec@chu-brest.fr', 'phone': '33 (0) 2 98 34 72 64'}], 'overallOfficials': [{'name': 'Valérie Devauchelle', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHRU Brest'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}