Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT05961267
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2023-07-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Gynecological Follow-up of Patients With Autoimmune Disease or Inflammatory Rheumatism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}, {'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D012595', 'term': 'Scleroderma, Systemic'}, {'id': 'D012859', 'term': "Sjogren's Syndrome"}, {'id': 'D008947', 'term': 'Mixed Connective Tissue Disease'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic 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'}, {'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D000844', 'term': 'Ankylosis'}, {'id': 'D012871', 'term': 'Skin 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 318}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-12', 'studyFirstSubmitDate': '2023-07-17', 'studyFirstSubmitQcDate': '2023-07-17', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients who report having a screening of cervical dysplasia during the year according to international recommendations.', 'timeFrame': 'At baseline (Day 0)'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients who report using effective contraception during the year.', 'timeFrame': 'At baseline (Day 0)'}, {'measure': 'Proportion of patients who report that their auto-immune pathology had an impact on their pregnancy plans.', 'timeFrame': 'At baseline (Day 0)'}, {'measure': 'Proportion of patients whose contraception does not comply with recommendations regarding their comorbidities.', 'timeFrame': 'At baseline (Day 0)'}, {'measure': 'Prevalence of HPV infections in the study sample.', 'timeFrame': 'At baseline (Day 0)'}, {'measure': 'Prevalence of cervical dysplasia in the study sample.', 'timeFrame': 'At baseline (Day 0)'}, {'measure': 'Prevalence of cervical cancer in the study sample.', 'timeFrame': 'At baseline (Day 0)'}, {'measure': 'Proportion of patients who report not having consulted their gynecologist during the year.', 'timeFrame': 'At baseline (Day 0)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Auto-immune diseases', 'rare auto-immune diseases', 'contraception', 'gynecological follow-up'], 'conditions': ['Arthritis, Rheumatoid', 'Spondylitis, Ankylosing', 'Lupus Erythematosus, Systemic', 'Scleroderma, Systemic', "Sjogren's Syndrome", 'Mixed Connective Tissue Disease']}, 'descriptionModule': {'briefSummary': 'Autoimmune diseases are the consequence of an abnormality of the immune system, leading it to attack components of our own body. They have a wide variety of presentations. They preferentially affect women, and often at a young age. Systemic lupus erythematosus, for example, most often occurs between the ages of 15 and 40.\n\nInflammatory rheumatism, such as spondyloarthritis or rheumatoid arthritis, is less prevalent in women, but also affects young people, and is particularly common.\n\nSeveral disease-modifying treatments exist, depending on the severity and evolutivitý of the disease. Some are contraindicated or not recommended during pregnancy and therefore require supervision of pregnancy plans.\n\nIn addition, some treatments have an immunosuppressive activitý, which implies an annual screening of cervical lesions by cervico-uterine smear.\n\nIn this context, an adapted gynecological follow-up seems indispensable. The rheumatologist and the internist physician have a crucial role in advising and referring patients to their gynecological colleagues.\n\nStudying the qualitý of this gynecological follow-up in a cohort of patients with autoimmune disease or inflammatory rheumatism is of major interest.', 'detailedDescription': "To evaluate the gynecological follow-up of patients with autoimmune diseases or inflammatory rheumatism by:\n\n* Assessing the proportion of patients reporting having contraception described as effective by guidelines within one year in the study population.\n* Evaluating the proportion of patients reporting having had a consultation for screening or follow-up for cervical dysplasia in the year.\n\nDescriptive analysis of :\n\n* Factors associated with effective contraceptive use and frequency of cervical smear screening.\n* The impact of the disease on the pregnancy project.\n* The appropriateness of the chosen contraceptive and the patients' comorbidities.\n* The prevalence of Human Papillomavirus (HPV) infections, cervical dysplasia, cervical cancer in this French population at risk.\n* Barriers to gynecological care."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Patient with a diagnosis of systemic lupus erythematosus, Gougerot-Sjögren's syndrome, scleroderma, Sharp's syndrome, rheumatoid arthritis or spondyloarthritis, according to current international standards.", 'eligibilityCriteria': "Inclusion Criteria:\n\n* Female patient over 18 years of age\n* Non-menopausal patient (only for the subgroup of patients used to assess the use of effective contraception)\n* Patient with a diagnosis of systemic lupus erythematosus, Gougerot-Sjögren's syndrome, scleroderma, Sharp's syndrome, rheumatoid arthritis or spondyloarthritis, according to current international standards.\n* French-speaking patient with no comprehension problems\n* Person affiliated with or benefiting from a social securitý scheme\n* Patient who received information about the protocol and gavé her consent\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding patient\n* Patient with a history of total hysterectomy\n* Patient referred to in articles L 1121-5 to L 1121-8 (persons deprived of liberty by a judicial or administrative decision, minors, adults subject to a legal protection measure or unable to express their consent)."}, 'identificationModule': {'nctId': 'NCT05961267', 'acronym': 'MARIGYN', 'briefTitle': 'Study of Gynecological Follow-up of Patients With Autoimmune Disease or Inflammatory Rheumatism', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'Study of Gynecological Follow-up of Patients With Autoimmune Disease or Inflammatory Rheumatism', 'orgStudyIdInfo': {'id': 'CHUBX 2023/25'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': "Patients with a diagnosis of systemic lupus erythematosus, Gougerot-Sjögren's syndrome, scleroderma, Sharp's syndrome, rheumatoid arthritis or spondyloarthritis, according to current international standards.", 'interventionNames': ['Behavioral: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'BEHAVIORAL', 'description': 'A gynecological follow-up questionnaire will be proposed to patients with one of the above mentioned pathologies. This is a standardized questionnaire specifically designed for this study.', 'armGroupLabels': ['Patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bordeaux', 'country': 'France', 'facility': 'CHU de Bordeaux - service de rhumatologie', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}], 'overallOfficials': [{'name': 'Christophe RICHEZ, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Bordeaux'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}