NCT05071742

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 8, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

November 25, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

November 16, 2021

Status Verified

November 1, 2021

Enrollment Period

2.1 years

First QC Date

September 24, 2021

Last Update Submit

November 13, 2021

Conditions

Keywords

IBD;gene;Chinese Han population

Outcome Measures

Primary Outcomes (1)

  • Correlation of genetic susceptibility genes to inflammatory bowel disease in Chinese Han population

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

    2021-2024

Study Arms (2)

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

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

Interventions

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

Also known as: DNA is extracted and genetic testing is performed
IBD groupcontrol group

Eligibility Criteria

Age18 Years - 75 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsAdults who have not undergone acquired sex reassignment surgery can be included
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

IBD patients or healthy controls who met the inclusion criteria

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

RECRUITING

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.

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Ting Li, PHD

    Second Affiliated Hospital of Wenzhou Medical University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
attending doctor

Study Record Dates

First Submitted

September 24, 2021

First Posted

October 8, 2021

Study Start

November 25, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

November 16, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations