Clinical trial Recruiting at 1 site Observational Ages 16 and up

LRG levels and IBD activity in European patients

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

Run by Imelda GI Clinical Research Center · NCT07621783 · Data updated 2026-11-12

This study will test whether Leucine-rich α2-glycoprotein (LRG) levels reflect disease activity in adults with Crohn’s or ulcerative colitis who are undergoing routine endoscopy in Europe.

More Ulcerative Colitis (UC) trials

Quick facts

Study typeObservational
Ages16 Years and up
SexAll
Enrollment100 (estimated)
SponsorImelda GI Clinical Research Center
Academic / other
Locations1 site (Bonheiden)
StatusRecruiting
StartedMay 1, 2026
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedJune 2, 2026
Trial IDNCT07621783 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (18+) with confirmed IBD (Crohn’s disease or ulcerative colitis) who are scheduled for endoscopy as part of routine care in Europe and who can provide informed consent.

Probably not a fit

Patients who do not have active disease or who do not have endoscopic assessment planned may see little, if any, diagnostic benefit from LRG testing in this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational, prospective study focusing on adults with inflammatory bowel disease in Europe. Researchers will measure LRG and compare it to clinical assessments, endoscopic findings, and histology obtained as part of routine care. The aim is to see if LRG can serve as a biomarker that correlates with disease activity across Crohn’s disease and ulcerative colitis. Participation requires planned endoscopy and informed consent, with data collected during standard clinical workflows. No experimental interventions beyond measuring LRG are involved.

Why it matters

Potential benefit: If successful, LRG testing could help doctors gauge disease activity with a simple blood marker, potentially reducing the need for frequent invasive procedures.

How similar studies have gone: Previous research in IBD has explored biomarkers related to endoscopic activity, with mixed levels of success; this study adds European prospectively collected data on LRG correlations.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Imelda General Hospital
    Bonheiden, Belgium
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Familial IBD Early Risk

    This study tests whether clinical, environmental, and immune factors in first-degree relatives of people with Crohn’s disease or ulcerative colitis can predict who will develop IBD.

    Recruiting Seattle Children's Hospital · Seattle, Washington · NCT07791862

  • Biomarker Discovery and Validation Platform for Inflammatory Bowel Disease

    Researchers are testing biomarker models to see if they can measure and predict inflammation and treatment response in people with Crohn's disease, ulcerative colitis, or related IBD.

    Recruiting Sixth Affiliated Hospital, Sun Yat-sen University · Guangzhou, Guangdong and 1 other locations · NCT07686406

  • Wearable data to spot IBD flareups in people with ulcerative colitis or Crohn's disease

    This study tests whether heart‑rate variability from participants’ own wearables can help predict IBD flares.

    Recruiting at 2 sites Maastricht University Medical Center · 's-Hertogenbosch and 2 other locations · NCT07647640

  • Individualizing Anti-TNF Therapy in IBD

    This study tests whether genetic markers can predict which anti-TNF–naïve IBD patients will respond to their first anti-TNF treatment.

    Recruiting Tel-Aviv Sourasky Medical Center · Tel Aviv · NCT07644117

  • CEDUR — German inflammatory bowel disease registry

    This registry collects real-world health and treatment information from adults with Crohn's disease, ulcerative colitis, or indeterminate colitis in Germany to see how care, effectiveness, safety, and costs play out in routine practice.

    Recruiting ImmunoRegister gUG · Hamburg · NCT07319442

  • Reducing ustekinumab dosing for Crohn's disease and ulcerative colitis

    This will try giving ustekinumab less often—changing from every 4 or 8 weeks to every 8 or 12 weeks—to see if people with Crohn's disease or ulcerative colitis in deep remission can stay well.

    Recruiting Phase 4 McGill University Health Centre/Research Institute of the McGill University Health Centre · Montreal, Quebec · NCT07303686

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.