CGSGIBDCHP: Correlation of Genetic Susceptibility Genes to Inflammatory Bowel Disease in Chinese Han Population

Sponsor
Second Affiliated Hospital of Wenzhou Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05071742
Collaborator
(none)
500
1
37.2
13.4

Study Details

Study Description

Brief Summary

The pathogenesis of IBD is still unclear, and the disease characteristics of IBD patients are affected by genetic susceptibility genes. Therefore, this study aims to explore the relationship between genetic susceptibility genes of IBD and the pathogenesis of IBD in Chinese Han population, in order to clarify the pathogenesis of IBD and provide basis for individualized treatment of IBD.

Condition or Disease Intervention/Treatment Phase
  • Genetic: 2ml peripheral venous blood was collected to detect genetic genes

Detailed Description

The pathogenesis of IBD is still unclear, and the disease characteristics of IBD patients are affected by genetic susceptibility genes. Therefore, this study aims to explore the relationship between genetic susceptibility genes of IBD and the pathogenesis of IBD in Han Chinese, in order to clarify the pathogenesis of IBD and provide basis for individualized treatment of IBD.In this study, 5ml peripheral venous blood was drawn from IBD patients and normal controls for gene testing.To investigate the relationship between polymorphisms of TRAIL, ITGA4, ICAM1, ITGA4, ICAM1, LTA, FCGR3A, TRAP1, TNFRSF1B, CDKN2B-AS1 and susceptibility to IBD in Chinese Han population.

Study Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Correlation of Genetic Susceptibility Genes to Inflammatory Bowel Disease in Chinese Han Population
Anticipated Study Start Date :
Nov 25, 2021
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
IBD group

According to the consensus opinions on diagnosis and Treatment of Inflammatory Bowel Disease (Beijing, 2018) formulated by Chinese Society of Gastroenterology, Chinese Medical Association The diagnosis of IBD was confirmed by clinical, laboratory, radiographic, digestive endoscopy and histopathological examination.

Genetic: 2ml peripheral venous blood was collected to detect genetic genes
Extraction of whole genome DNA: 2 mL of peripheral fasting venous blood was extracted, and edTA disodium was anticoagulant.The whole-genome DNA was extracted strictly in accordance with the instructions of the blood genomic DNA extraction kit (Beijing Tiagen Biochemical Technology Co., LTD., China), and the DNA concentration and purity were detected by nanodrop-1000 spectrophotometer (Thermo, USA). The DNA was diluted to 10 ng/μL and stored in a refrigerator at -80℃ for future use. (2) Primer design and synthesis: (3) Gene polymorphism detection 4) Resin purification 5) Spot chip and mass spectrometry detection
Other Names:
  • DNA is extracted and genetic testing is performed
  • control group

    During the same period, healthy subjects were collected from the physical examination center of our hospital as subjects of the normal control group. Infectious diarrhea, ischemic bowel disease, radiation enteritis, gastrointestinal tumor, diabetes, systemic lupus erythematosus, rheumatoid arthritis and autoimmune thyroiditis were excluded from all clinical examinations before inclusion.

    Genetic: 2ml peripheral venous blood was collected to detect genetic genes
    Extraction of whole genome DNA: 2 mL of peripheral fasting venous blood was extracted, and edTA disodium was anticoagulant.The whole-genome DNA was extracted strictly in accordance with the instructions of the blood genomic DNA extraction kit (Beijing Tiagen Biochemical Technology Co., LTD., China), and the DNA concentration and purity were detected by nanodrop-1000 spectrophotometer (Thermo, USA). The DNA was diluted to 10 ng/μL and stored in a refrigerator at -80℃ for future use. (2) Primer design and synthesis: (3) Gene polymorphism detection 4) Resin purification 5) Spot chip and mass spectrometry detection
    Other Names:
  • DNA is extracted and genetic testing is performed
  • Outcome Measures

    Primary Outcome Measures

    1. Correlation of genetic susceptibility genes to inflammatory bowel disease in Chinese Han population [2021-2024]

      The difference in mutation frequency of different gene loci between IBD patients and control group was compared.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Confirmed IBD patients were collected from the Department of Gastroenterology, The Second Affiliated Hospital of Wenzhou Medical University.According to the consensus of "Diagnosis and treatment of inflammatory bowel disease" formulated by Chinese Society of Gastroenterology, the diagnosis of IBD was established by clinical, laboratory, radiographic, digestive endoscopy and histopathological examination.During the same period, 476 healthy subjects were collected from the physical examination center of our hospital as the normal control group
    Exclusion Criteria:
    • Active infection, malignant tumor, congestive heart failure, demyelination of nervous system, allergy to rat derived protein components, etc All subjects were excluded from infectious diarrhea, ischemic enteropathy, radiation enteritis, gastrointestinal tumor, diabetes, systemic lupus erythematosus, rheumatoid arthritis and autoimmune thyroiditis by clinical examination before inclusion.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Second Affiliated Hospital of Wenzhou Medical University Wenzhou Zhejiang China 325000

    Sponsors and Collaborators

    • Second Affiliated Hospital of Wenzhou Medical University

    Investigators

    • Study Director: Ting Li, PHD, Second Affiliated Hospital of Wenzhou Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xiao xiao Shao, attending doctor, Second Affiliated Hospital of Wenzhou Medical University
    ClinicalTrials.gov Identifier:
    NCT05071742
    Other Study ID Numbers:
    • SAHoWMU-CR2021-01-206
    First Posted:
    Oct 8, 2021
    Last Update Posted:
    Nov 16, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Xiao xiao Shao, attending doctor, Second Affiliated Hospital of Wenzhou Medical University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 16, 2021