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

NCT ID: NCT06961435

Last Updated: 2025-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

900 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2025-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Colitis, Ulcerative

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Vedolizumab

Intervention Type 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.

normal control

no biological agents treatment

No interventions assigned to this group

Interventions

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Vedolizumab

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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Second Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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the Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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SAHoWMU-CR2025-01-219

Identifier Type: -

Identifier Source: org_study_id

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