The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05071742
Recruitment Status : Recruiting
First Posted : October 8, 2021
Last Update Posted : November 16, 2021
Sponsor:
Information provided by (Responsible Party):
Xiao xiao Shao, Second Affiliated Hospital of Wenzhou Medical University

Tracking Information
First Submitted Date September 24, 2021
First Posted Date October 8, 2021
Last Update Posted Date November 16, 2021
Estimated Study Start Date November 25, 2021
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 7, 2021)		 Correlation of genetic susceptibility genes to inflammatory bowel disease in Chinese Han population [ Time Frame: 2021-2024 ]
The difference in mutation frequency of different gene loci between IBD patients and control group was compared.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Correlation of Genetic Susceptibility Genes to Inflammatory Bowel Disease in Chinese Han Population
Official Title Correlation of Genetic Susceptibility Genes to Inflammatory Bowel Disease in Chinese Han Population
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.
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole-genome DNA extraction: 2 mL peripheral fasting venous blood was extracted from IBD patients or control group, and edTA disodium was anticoagulant.The whole genome DNA was extracted in strict accordance with the instructions of the blood genomic DNA extraction Kit. The concentration and purity of DNA were detected by nanodrop-1000 spectrophotometer. The DNA was diluted to 10 ng/μL and stored in the refrigerator at -80℃ for future use.
Sampling Method Probability Sample
Study Population IBD patients or healthy controls who met the inclusion criteria
Condition
  • Gene Abnormality
  • Inflammatory Bowel Disease
  • Chinese
Intervention 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 Name: DNA is extracted and genetic testing is performed
Study Groups/Cohorts
  • 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.
    Intervention: Genetic: 2ml peripheral venous blood was collected to detect genetic genes
  • 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.
    Intervention: Genetic: 2ml peripheral venous blood was collected to detect genetic genes
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 7, 2021)		 500
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2024
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Gender Eligibility Description: Adults who have not undergone acquired sex reassignment surgery can be included
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Yi Jiang, PHD +86 13676715542 wzjiangyi@yeah.net
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT05071742
Other Study ID Numbers SAHoWMU-CR2021-01-206
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Xiao xiao Shao, Second Affiliated Hospital of Wenzhou Medical University
Original Responsible Party Same as current
Current Study Sponsor Second Affiliated Hospital of Wenzhou Medical University
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Director: Ting Li, PHD Second Affiliated Hospital of Wenzhou Medical University
PRS Account Second Affiliated Hospital of Wenzhou Medical University
Verification Date November 2021