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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07621783
Acronym
LEADER
Enrollment
100
Registered
2026-06-02
Start date
2026-05-01
Completion date
2026-12-31
Last updated
2026-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease (CD), Ulcerative Colitis (UC)

Keywords

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

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.

Interventions

DIAGNOSTIC_TESTLeucine-rich α2-glycoprotein

Leucine-rich α2-glycoprotein measurement

Sponsors

Imelda GI Clinical Research Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Correlation between LRG serum level and endoscopic disease activity in CD and UCDay 1Correlation between LRG serum level and endoscopic disease activity in CD and UC

Countries

Belgium

Contacts

CONTACTPeter Bossuyt
peter.bossuyt@imelda.beMD PhD

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 3, 2026