Association Between LRG and Endoscopic Remission in Ulcerative Colitis

April 15, 2024 updated by: Akira Horiuchi, Showa Inan General Hospital

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

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

Study Overview

Status

Recruiting

Conditions

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 attempted to clarify the LRG level which predicts endoscopic remission in UC patients in this study.

Methods: Patients with UC were consecutively enrolled with the measurement of serum LRG. Colonoscopy with histology were performed when endoscopic remission was predicted based on serum LRG values, irrespective of symptoms. Serum LRG levels were 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 Geboes score was used for histopathological findings. We analyzed the area under receiver operating characteristic (ROC) curves to evaluate the diagnostic ability of LRG for predicting endoscopic remission of UC. In addition, the clinical features of UC patients with endoscopic remission were examined.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
      • Komagane, Japan
        • Recruiting
        • Showa Inan General Hospital
        • Contact:
          • Akira Horiuchi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Active UC patients

Description

Inclusion Criteria:

  • active UC patients

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Endoscopic remission of UC
Time Frame: 1 week
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Showa Inan General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

April 15, 2024

First Submitted That Met QC Criteria

April 15, 2024

First Posted (Actual)

April 18, 2024

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LRG&UC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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