NCT07621783

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
6mo left

Started May 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
May 2026Dec 2026

Study Start

First participant enrolled

May 1, 2026

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

May 24, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 2, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

June 2, 2026

Status Verified

May 1, 2026

Enrollment Period

8 months

First QC Date

May 24, 2026

Last Update Submit

May 29, 2026

Conditions

Crohn Disease (CD)Ulcerative Colitis (UC)

Keywords

Crohn; ulcerative colitis, LRG, endoscopic remission, endoscopic activity, PRO, quality of life

Outcome Measures

Primary Outcomes (1)

  • Correlation between LRG serum level and endoscopic disease activity in CD and UC

    Correlation between LRG serum level and endoscopic disease activity in CD and UC

    Day 1

Study Arms (1)

patient with IBD

patient with Crohn or ulcerative colitis

Diagnostic Test: Leucine-rich α2-glycoprotein

Interventions

Leucine-rich α2-glycoproteinDIAGNOSTIC_TEST

Leucine-rich α2-glycoprotein measurement

patient with IBD

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with IBD

You may qualify if:

  • ≥18 years
  • Patient with confirmed diagnosis of IBD
  • 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
  • willing to provide informed consent

You may not qualify if:

  • Patient with IBD unspecified
  • Patient with ileo- or colostomy
  • Patient with total colectomy
  • Women that are pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imelda General Hospital

Bonheiden, 2820, Belgium

RECRUITING

MeSH Terms

Conditions

Crohn DiseaseColitis, Ulcerative

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Central Study Contacts

Peter Bossuyt

CONTACT

MD PhDpeter.bossuyt@imelda.be

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2026

First Posted

June 2, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

June 2, 2026

Record last verified: 2026-05

Locations

BE(1)