Association Between LRG and Histologic Remission in Ulcerative Colitis

Ulcerative Colitis in Histologic Remission Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06372613
• Other study ID #: LRG&UC
• Status: Recruiting
• Start date: February 25, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Showa Inan General Hospital
• Contact: Akia Horiuchi
• Phone: 09021684311
• Email: horiuchi.akira[@]sihp.jp
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 when histologic remission is predicted, irrespective of symptoms or serum LRG values. Serum LRG levels are analyzed by an enzyme-linked immunosorbent assay.

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

• active UC patients

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer

Locations

Country	Name	City	State
Japan	Showa Inan General Hospital	Komagane

Sponsors (1)

Lead Sponsor	Collaborator
Showa Inan General Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histologic remission of UC	Histologic remission is defined as < grade 2 using Geboes score.	1 week
Secondary	Endoscopic remission	Endoscopic remission is defined as score 0 using the Mayo endoscopic subscore.	1 week