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Completed

NCT Number: NCT06873711

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

the Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

About this study

From January 2020 to December 2024, diagnosed UC patients and gender- and age-matched normal controls were enrolled from the Department of Gastroenterology, the Second Affiliated Hospital of Wenzhou Medical University. Genotypes of miRNAs were determined by multiplex polymerase chain reaction-ligase detection reaction technique. Chi-square test and unconditional logistic regression model were used to analyze the difference in distribution of miRNAs gene polymorphisms between UC group and normal control group, as well as the effects of miRNAs gene variations on the clinicopathological characteristics and 14-week clinical response to VDZ treatment of UC patients.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Genotypes of miRNAs

    Time frame: Baseline

    multiplex polymerase chain reaction-ligase detection reaction technique

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Mar 13, 2025
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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