Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-04-09 @ 3:19 AM
Study NCT ID:
NCT07057856
Status:
COMPLETED
Last Update Posted:
2025-07-10
First Post:
2025-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Analysis of the Relationship Between the Genetic Polymorphisms of Interleukin 12 Receptor Subunit Beta 1 and Crohn's Disease in Chinese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069549', 'term': 'Ustekinumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Extract whole genome DNA from peripheral blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 866}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2025-06-30', 'studyFirstSubmitQcDate': '2025-06-30', 'lastUpdatePostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Genotypes of IL-12RB1', 'timeFrame': 'Baseline', 'description': 'multiplex polymerase chain reaction-ligase detection reaction technique'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Crohn's Disease"]}, 'descriptionModule': {'briefSummary': "From January 2018 to May 2025, diagnosed CD patients and gender- and age-matched normal controls were collected from Department of Gastroenterology, the Second Affiliated Hospital of Wenzhou Medical University. Our study aimed to explore the associations of interleukin 12 receptor subunit beta 1 (IL-12RB1) gene polymorphisms with the risk and clinicopathological characteristics of Crohn's disease (CD), and to analyze the effects of IL-12RB1 gene variations on the clinical response of ustekinumab (UST) treatment in CD patients at week 8.", 'detailedDescription': 'From January 2018 to May 2025, diagnosed CD patients and gender- and age-matched normal controls were collected from Department of Gastroenterology, the Second Affiliated Hospital of Wenzhou Medical University. Genotypes of IL-12RB1 were examined by multiplex polymerase chain reaction-ligase detection reaction technique. Unconditional logistic regression analysis was employed to analyze the distribution differences of IL-12RB1 gene polymorphisms between CD group and normal control group, as well as their influences on the clinicopathological characteristics and 8-week clinical response to UST treatment of CD patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'There was no statistically significant difference in the gender ratio, average age, and proportion of smokers between CD group and normal control group. All study subjects are from the Zhejiang Han population who are not related by blood', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed CD based on comprehensive clinical, colonoscopy, histopathological, laboratory, and radiographic examination results\n\nExclusion Criteria:\n\n* rheumatoid arthritis, systemic lupus erythematosus, intestinal tuberculosis, ischemic enteritis, radiation enteritis, tumors, etc.'}, 'identificationModule': {'nctId': 'NCT07057856', 'briefTitle': "An Analysis of the Relationship Between the Genetic Polymorphisms of Interleukin 12 Receptor Subunit Beta 1 and Crohn's Disease in Chinese Patients", 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital of Wenzhou Medical University'}, 'officialTitle': "An Analysis of the Relationship Between the Genetic Polymorphisms of Interleukin 12 Receptor Subunit Beta 1 and Crohn's Disease in Chinese Patients", 'orgStudyIdInfo': {'id': 'SAHoWMU-CR2025-01-222'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CD patients', 'description': 'Some CD patients received UST treatment and the first sufficient dose of UST (6mg/kg) was administered intravenously.', 'interventionNames': ['Biological: Ustekinumab (UST)']}, {'label': 'normal control', 'description': 'no biological agents treatment'}], 'interventions': [{'name': 'Ustekinumab (UST)', 'type': 'BIOLOGICAL', 'description': 'The first sufficient dose of UST (6mg/kg) was administered intravenously at weeks 0', 'armGroupLabels': ['CD patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wenzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'the Second Affiliated Hospital of Wenzhou Medical University', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital of Wenzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}