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Completed

NCT Number: NCT06961435

An Analysis of the Relationship Between the Genetic Polymorphisms of Plasminogen Activator Inhibitor-1 and Ulcerative Colitis in Chinese Patients

From January 2019 to February 2025, 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 study aimed to explore the associations of plasminogen activator inhibitor-1 (PAI-1) gene polymorphisms with the risk and clinicopathological characteristics of UC, and to analyze the effects of PAI-1 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, 325000, China

About this study

From January 2019 to February 2025, 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. Genotypes of PAI-1 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 PAI-1 gene polymorphisms between UC group and normal control group, as well as the effects of PAI-1 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 PAI-1

    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

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
May 8, 2025
Registry last updated
May 8, 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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