Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2026-01-22 @ 9:22 AM
Study NCT ID:
NCT05494203
Status:
UNKNOWN
Last Update Posted:
2022-08-12
First Post:
2022-08-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-omics Study and Drug Intervention Study of Spondyloarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D025241', 'term': 'Spondylarthritis'}], 'ancestors': [{'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'whole blood, serum, urine, fecal sample, saliva, Plaque'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-11', 'studyFirstSubmitDate': '2022-08-06', 'studyFirstSubmitQcDate': '2022-08-06', 'lastUpdatePostDateStruct': {'date': '2022-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Long-term outcomes after treatment', 'timeFrame': '1 year', 'description': 'disease activity'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spondylarthritis']}, 'descriptionModule': {'briefSummary': 'Spondyloarthritis (SpA) is a type of chronic inflammatory rheumatic disease that mainly affects the spine and peripheral joints, or joints, ligaments and tendons. This disease subtype has the same clinical and immunological features. Further explore the pathogenesis of spondyloarthritis, explore the guiding significance of different imaging examinations for spondyloarthritis, and study the efficacy and mechanism of different drugs for spondyloarthritis.', 'detailedDescription': '1. Clinical phenotype research. The clinical phenotype is the symptoms and signs of the disease and its evolution. Through the clinical phenotype research of spondyloarthritis, it is helpful to realize the diagnosis and grading of spondyloarthritis and help to achieve individualization Precise treatment.\n2. Transcriptomic research. The key genes and pathways involved in the pathogenesis of spondyloarthritis can be explored through transcriptomic research of spondyloarthritis, which can provide help for early diagnosis and seeking potential treatment methods.\n3. Microbiological research. Through the microbiome research on spondyloarthritis, the composition and function of intestinal flora in patients with spondyloarthritis can be deeply analyzed to provide help for diagnosis and treatment.\n4. Radiomics research. Through the radiomics research on spondyloarthritis, it is helpful to realize the diagnosis and grading of spondyloarthritis and the evaluation and prediction of treatment.\n5. Drug treatment research By studying the therapeutic effects of different drugs in patients with spondyloarthritis, it is helpful to explore the efficacy and mechanism of different drugs on spondyloarthritis, and to achieve precise and individualized treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'community sample', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient meets the revised AS New York diagnostic criteria or ASAS axial SpA classification criteria.\n\nExclusion Criteria:\n\n* patients with rheumatoid arthritis, scleroderma, systemic lupus erythematosus and other immune system diseases;\n* patients who had received head and neck radiotherapy;\n* patients with history of antidepressants and parasympathetic stimulants;\n* patients known to be infected with human immunodeficiency virus (HIV) or hepatitis C virus;\n* patients with sarcoidosis or tuberculosis infection.\n* patients with inflammatory bowel disease or uveitis.'}, 'identificationModule': {'nctId': 'NCT05494203', 'briefTitle': 'Multi-omics Study and Drug Intervention Study of Spondyloarthritis', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Wenzhou Medical University'}, 'officialTitle': 'Multi-omics Study and Drug Intervention Study of Spondyloarthritis', 'orgStudyIdInfo': {'id': 'XiaobingWang'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'spa', 'description': 'Untreated patients meeting the revised AS New York diagnostic criteria or the ASAS classification criteria for axial SpA. Exclusion criteria: ① Patients with rheumatoid arthritis, scleroderma, systemic lupus erythematosus and other diseases of the immune system; ② Patients who have received head and neck radiation therapy; ③ Those who have a history of using antidepressants and parasympathetic stimulants; ④ Known infection with human immunodeficiency virus (HIV) or hepatitis C virus; ⑤ Patients with sarcoidosis or tuberculosis infection. According to the existing ethical approval documents, the patients signed the informed consent.', 'interventionNames': ['Diagnostic Test: questionnaire survey']}, {'label': 'HC', 'description': 'healthy control. Exclusion criteria: ① Patients with rheumatoid arthritis, scleroderma, systemic lupus erythematosus and other diseases of the immune system; ② Patients who have received head and neck radiation therapy; ③ Those who have a history of using antidepressants and parasympathetic stimulants; ④ Known infection with human immunodeficiency virus (HIV) or hepatitis C virus; ⑤ Patients with sarcoidosis or tuberculosis infection. According to the existing ethical approval documents, the patients signed the informed consent.'}], 'interventions': [{'name': 'questionnaire survey', 'type': 'DIAGNOSTIC_TEST', 'description': 'All patients received lifestyle questionnaire, medical history, physical signs, auxiliary examination and laboratory examination results before treatment.', 'armGroupLabels': ['spa']}]}, 'contactsLocationsModule': {'locations': [{'zip': '325000', 'city': 'Wenzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Xiaobing Wang', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Wenzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor, Principal Investigator', 'investigatorFullName': 'XiaobingWang', 'investigatorAffiliation': 'First Affiliated Hospital of Wenzhou Medical University'}}}}