The Associations of Microribonucleic Acid Gene Polymorphisms With the Risk of Ulcerative Colitis

NCT06873711 | Completed FDA Drug

• 1 other identifier: SAHoWMU-CR2025-01-206
• Study Type: observational
• Target: 926
• Locations: 1 country
• Sites: 1

Brief Summary

From January 2020 to December 2024, diagnosed ulcerative colitis(UC) patients and gender- and age-matched normal controls were enrolled from the Department of Gastroenterology, the Second Affiliated Hospital of Wenzhou Medical University. Our aim is to investigate the associations of microribonucleic acid(miRNA) gene polymorphisms with the risk and clinicopathological characteristics of UC, and to analyze the effects of miRNAs gene variations on the clinical response of vedolizumab(VDZ) treatment in UC patients.

Conditions

Colitis, Ulcerative

Outcome Measures

Primary Outcomes (1)

• Genotypes of miRNAs

  multiplex polymerase chain reaction-ligase detection reaction technique

  Baseline

Study Arms (2)

UC patients

Some UC patients received intravenous injection of VDZ (300mg/time) at weeks 0, 2, and 6, followed by intravenous injection of the same dose of VDZ every 8 weeks to maintain treatment.

Biological: vedolizumab

normal control

no biological agents treatment

Interventions

vedolizumab BIOLOGICAL

Intravenous injection of VDZ (300mg/time) at weeks 0, 2, and 6, followed by intravenous injection of the same dose of VDZ every 8 weeks to maintain treatment.

UC patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

There was no statistically significant difference in the gender ratio, average age, and proportion of smokers between UC group and normal control group. All study subjects are from the Zhejiang Han population who are not related by blood.

You may qualify if:

• diagnosed UC based on comprehensive clinical, colonoscopy, histopathological, laboratory, and radiographic examination results

You may not qualify if:

• rheumatoid arthritis, systemic lupus erythematosus, intestinal tuberculosis, ischemic enteritis, radiation enteritis, tumors, etc.

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

the Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Extract whole genome DNA from peripheral blood

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

vedolizumab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2025
• First Posted: March 13, 2025
• Study Start: January 1, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)