Gene AbnormalityCGSGIBDCHPNCT05071742
Correlation of Genetic Susceptibility Genes to Inflammatory Bowel Disease in Chinese Han Population
An observational study of Gene Abnormality and Inflammatory Bowel Disease, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Gene Abnormality, Inflammatory Bowel Disease, Chinese
- What is being tested?
- 2ml peripheral venous blood was collected to detect genetic genes
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 25 Nov 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: IBD patients or healthy controls who met the inclusion criteria
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Xiaoxiao Shao, PHD, +8615967465468, 494311941@qq.com
About this study
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.
Read the 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.
- Conditions
- Gene Abnormality, Inflammatory Bowel Disease, Chinese
- Being tested
- 2ml peripheral venous blood was collected to detect genetic genes
- Keywords
- IBD;gene;Chinese Han population
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2ml peripheral venous blood was collected to detect genetic genesGenetic
Also called DNA is extracted and genetic testing is performed
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Genetic: 2ml peripheral venous blood was collected to detect genetic genes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2021-2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start25 Nov 2021 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gene AbnormalityStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao xiao Shao, Second Affiliated Hospital of Wenzhou Medical University
- Investigators
- Ting Li, PHD, Study director, Second Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05071742
- Sponsor's protocol ID
- SAHoWMU-CR2021-01-206
- Acronym
- CGSGIBDCHP
- Status last verified
- Nov 2021
- First submitted
- 24 Sep 2021
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Genetic Susceptibility Genes to Inflammatory Bowel Disease in Chinese Han Population
- ClinicalTrials.gov ID
- NCT05071742
- Acronym / sponsor ID
- CGSGIBDCHP / SAHoWMU-CR2021-01-206
- Conditions
- Gene Abnormality, Inflammatory Bowel Disease, Chinese
- Keywords
- IBD;gene;Chinese Han population
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 25 Nov 2021 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 8 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBD group | – | Genetic: 2ml peripheral venous blood was collected to detect genetic genesAccording 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. |
| control group | – | Genetic: 2ml peripheral venous blood was collected to detect genetic genesDuring 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- IBD patients or healthy controls who met the inclusion criteria
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2ml peripheral venous blood was collected to detect genetic genesAlso: DNA is extracted and genetic testing is performedExtraction 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 | Genetic | IBD group, control group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ting Li, PHD study director
Second Affiliated Hospital of Wenzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gene Abnormality and Inflammatory Bowel Disease, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Jiang, PHD (+86 13676715542, wzjiangyi@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of genetic susceptibility genes to inflammatory bowel disease in Chinese Han population (time frame: 2021-2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2021; AzTrials last refreshed its copy on 8 Nov 2026.