Association Between LRG and Histologic Remission in Ulcerative Colitis

NCT ID: NCT06372613

Last Updated: 2025-08-22

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

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-25

Study Completion Date

2025-12-31

Brief Summary

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We attempt to clarify the serum leucine-rich α 2-glycoprotein (LRG) level which can predict histologic remission in ulcerative colitis patients in this study. Colonoscopy with histology will be performed when histologic remission is predicted, irrespective of symptoms or serum LRG values. Serum LRG levels are analyzed by an enzyme-linked immunosorbent assay.

Detailed Description

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Aim: Serum leucine-rich α 2-glycoprotein (LRG) may be a noninvasive biomarker for monitoring disease activity in patients with ulcerative colitis (UC). We attempt to clarify the LRG level which predicts histologic remission in UC patients in this study.

Methods: Patients with UC were consecutively enrolled with the measurement of serum LRG. Colonoscopy with histology is performed when histologic remission is predicted, irrespective of symptoms or serum LRG values. Serum LRG levels are analyzed by an enzyme-linked immunosorbent assay. For the evaluation of UC activity, clinical remission was defined as score 1 or 0 using the partial Mayo score and endoscopic remission was defined as score 0 using the Mayo endoscopic subscore. And histologic remission is defined as \< grade 2 using Geboes score. We analyze the area under receiver operating characteristic (ROC) curves to evaluate the diagnostic ability of LRG for predicting histologic remission of UC.

Conditions

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Ulcerative Colitis in Histologic Remission

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* active UC patients

Exclusion Criteria

* None
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Showa Inan General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Akira Horiuchi

Chief, Digestive Disease Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Showa Inan General Hospital

Komagane, , Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Akia Horiuchi

Role: CONTACT

09021684311

Facility Contacts

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Akira Horiuchi

Role: primary

Other Identifiers

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LRG&UC

Identifier Type: -

Identifier Source: org_study_id

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