Leucine-rich α2-glycoprotein Correlation With Clinical, Endoscopic and Histological Disease Activity of IBD in a EuRopean Context (LEADER)

May 29, 2026 updated by: Imelda GI Clinical Research Center

Leucine-rich α2-glycoprotein Correlation With Clinical, Endoscopic and Histological Disease Activity of IBD in a EuRopean Context: LEADER Trial.

Prospectively study the correlation between Leucine-rich α2-glycoprotein (LRG) and clinical/endoscopic/histological disease activity in patients with inflammatory bowel disease (IBD) in Europe.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

  • Belgium
      • Bonheiden, Belgium, 2820
        • Recruiting
        • Imelda General Hospital
        • Contact:

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

patients with IBD

Description

Inclusion Criteria:

  1. ≥18 years
  2. Patient with confirmed diagnosis of IBD
  3. Patient with planned endoscopy (ileocolonoscopy for Crohn's disease (CD)/ulcerative colitis (UC) or sigmoidoscopy for UC) for the assessment of endoscopic disease activity according to routine practice
  4. willing to provide informed consent

Exclusion Criteria:

  1. Patient with IBD unspecified
  2. Patient with ileo- or colostomy
  3. Patient with total colectomy
  4. Women that are pregnant

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patient with IBD
patient with Crohn or ulcerative colitis
Diagnostic test: Leucine-rich α2-glycoprotein
Leucine-rich α2-glycoprotein measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between LRG serum level and endoscopic disease activity in CD and UC
Time Frame: Day 1
Correlation between LRG serum level and endoscopic disease activity in CD and UC
Day 1

Collaborators and Investigators

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

Sponsor

Imelda GI Clinical Research Center

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)

May 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

May 24, 2026

First Submitted That Met QC Criteria

May 29, 2026

First Posted (Actual)

June 2, 2026

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • imelda202601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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