Association Between LRG and Histologic Remission in Ulcerative Colitis

What is the Level of Serum Leucine-rich α 2-glycoprotein (LRG) Which Predicts Histologic Remission in Patients With Ulcerative Colitis?

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06372613

Enrollment

100

Registered

2024-04-18

Start date

2024-02-25

Completion date

2027-12-31

Last updated

2026-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis in Histologic Remission

Brief summary

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 annually, irrespective of symptoms or serum LRG values. Serum LRG levels are analyzed by an enzyme-linked immunosorbent assay.

Detailed description

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 annually, 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 90 Years

Healthy volunteers

Inclusion criteria

* definitive UC patients based on the standard criteria

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame	Description
Histologic remission of UC	1 week	Histologic remission is defined as \< grade 2 using Geboes score.

Secondary

Measure	Time frame	Description
Endoscopic remission	1 week	Endoscopic remission is defined as score 0 using the Mayo endoscopic subscore.

Countries

Japan

Contacts

CONTACTAkia Horiuchi

horiuchi.akira@sihp.jp09021684311

Outcome results