The Associations of Plasminogen Activator Inhibitor-1 Gene Polymorphisms With Crohn's Disease in Chinese Patients

NCT ID: NCT06935942

Last Updated: 2025-04-20

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

906 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2025-01-01

Brief Summary

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From January 2020 to January 2025, Crohn's disease (CD) patients and gender- and age-matched normal controls were collected from the Department of Gastroenterology, the Second Affiliated Hospital of Wenzhou Medical University. The aim of this research is to explore the associations of plasminogen activator inhibitor-1 (PAI-1) gene polymorphisms with the risk and clinicopathological characteristics of CD, and to analyze the effects of PAI-1 gene variantions on the clinical response of ustekinumab (UST) treatment in CD patients at week 8.

Detailed Description

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From January 2020 to January 2025, a total of 311 CD patients and 495 gender- and age-matched normal controls were collected from the Department of Gastroenterology, the Second Affiliated Hospital of Wenzhou Medical University.The genotypes of PAI-1 were determined by multiplex polymerase chain reaction-ligase detection reaction technique. Unconditional logistic regression was employed to analyze the distribution of PAI-1 gene polymorphisms between CD group and normal control group, as well as their influences on the clinicopathological characteristics of CD patients. Multi-model logistic regression was used to explore the effect of PAI-1 gene variation on the clinical response of CD patients in the treatment of UST at week 8.

Conditions

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Crohn Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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CD patients

Some CD patients received sufficient UST (6 mg/kg) intravenous infusion at week 0, followed by one subcutaneous (SC) dose of 90 mg UST at 8 weeks. Maintenance therapy consisted of 90 mg subcutaneous UST every 8 or 12 weeks.

Ustekinumab - Standard Dosage

Intervention Type BIOLOGICAL

Some CD patients received sufficient UST (6 mg/kg) intravenous infusion at week 0, followed by one subcutaneous dose of 90 mg UST at week 8.Maintenance therapy consisted of 90 mg subcutaneous UST every 8 or 12 weeks.

normal controls

no biological agents treatment

No interventions assigned to this group

Interventions

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Ustekinumab - Standard Dosage

Some CD patients received sufficient UST (6 mg/kg) intravenous infusion at week 0, followed by one subcutaneous dose of 90 mg UST at week 8.Maintenance therapy consisted of 90 mg subcutaneous UST every 8 or 12 weeks.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

diagnosed CD 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-CR2025-01-212

Identifier Type: -

Identifier Source: org_study_id

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