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

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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

Study Description
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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
Gene Abnormality Inflammatory Bowel Disease Chinese 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
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Study Type : Observational
Estimated 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
Estimated Study Start Date : November 25, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort 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 Name: 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 Name: DNA is extracted and genetic testing is performed


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
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.

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Adults who have not undergone acquired sex reassignment surgery can be included
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
IBD patients or healthy controls who met the inclusion criteria
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05071742


Contacts
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Contact: Yi Jiang, PHD +86 13676715542 wzjiangyi@yeah.net

Locations
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China, Zhejiang
The Second Affiliated Hospital of Wenzhou Medical University Recruiting
Wenzhou, Zhejiang, China, 325000
Contact: Xiaoxiao Shao, PHD    +8615967465468    494311941@qq.com   
Sponsors and Collaborators
Second Affiliated Hospital of Wenzhou Medical University
Investigators
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Study Director: Ting Li, PHD Second Affiliated Hospital of Wenzhou Medical University
More Information
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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: October 8, 2021    Key Record Dates
Last Update Posted: November 16, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiao xiao Shao, Second Affiliated Hospital of Wenzhou Medical University:
IBD;gene;Chinese Han population
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Genetic Predisposition to Disease
Gastrointestinal Diseases
Digestive System Diseases
 Gastroenteritis
Disease Susceptibility
Disease Attributes
Pathologic Processes