NCT07398586

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. Investigators' aim is to investigate the associations of IL-7R gene polymorphisms with the risk and clinicopathological characteristics of UC, and to analyze the effects of IL-7R gene variations on the clinical response of vedolizumab(VDZ) treatment in UC patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
898

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2020

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 5, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 10, 2026

Completed
Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

5 years

First QC Date

January 5, 2026

Last Update Submit

February 9, 2026

Conditions

Ulcerative Colitis (UC)

Keywords

colitisulcerative

Outcome Measures

Primary Outcomes (1)

  • Genotypes of IL-7R

    multiplex polymerase chain reaction-ligase detection reaction technique

    Baseline

Study Arms (2)

UC patients

EXPERIMENTAL

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 INTERVENTION

no biological agents treatment

Interventions

VedolizumabBIOLOGICAL

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

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Colitis, UlcerativeColitisUlcer

Interventions

vedolizumab

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2026

First Posted

February 10, 2026

Study Start

January 1, 2020

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

February 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)