Crohn Disease (CD)LEADERNCT07621783
Leucine-rich α2-glycoprotein Correlation With Clinical, Endoscopic and Histological Disease Activity of IBD in a EuRopean Context
An observational study of Crohn Disease (CD) and Ulcerative Colitis (UC), run by Imelda GI Clinical Research Center at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Crohn Disease (CD), Ulcerative Colitis (UC)
- What is being tested?
- Leucine-rich α2-glycoprotein
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 1 May 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with IBD
Who may be able to join
- ≥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
Who cannot join
- Patient with IBD unspecified
- Patient with ileo- or colostomy
- Patient with total colectomy
- Women that are pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Imelda General Hospital
Bonheiden, 2820
Peter Bossuyt, MD PhD, +3215505691, peter.bossuyt@imelda.be
About this study
Official title: 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.
- Conditions
- Crohn Disease (CD), Ulcerative Colitis (UC)
- Being tested
- Leucine-rich α2-glycoprotein
- Keywords
- Crohn; ulcerative colitis, LRG, endoscopic remission, endoscopic activity, PRO, quality of life
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leucine-rich α2-glycoproteinDiagnostic test
Leucine-rich α2-glycoprotein measurement
| Study group | Role | What they receive |
|---|---|---|
| patient with IBD | patient with Crohn or ulcerative colitis Receives: Diagnostic Test: Leucine-rich α2-glycoprotein |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start1 May 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn Disease (CD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imelda GI Clinical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07621783
- Sponsor's protocol ID
- imelda202601
- Acronym
- LEADER
- Status last verified
- May 2026
- First submitted
- 24 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leucine-rich α2-glycoprotein Correlation With Clinical, Endoscopic and Histological Disease Activity of IBD in a EuRopean Context: LEADER Trial.
- ClinicalTrials.gov ID
- NCT07621783
- Acronym / sponsor ID
- LEADER / imelda202601
- Conditions
- Crohn Disease (CD), Ulcerative Colitis (UC)
- Keywords
- Crohn; ulcerative colitis, LRG, endoscopic remission, endoscopic activity, PRO, quality of life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Imelda GI Clinical Research CenterUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient with IBD | – | Diagnostic Test: Leucine-rich α2-glycoproteinpatient with Crohn or ulcerative colitis |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with IBD
Key inclusion criteria (4 listed)
- ≥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
Key exclusion criteria (4 listed)
- Patient with IBD unspecified
- Patient with ileo- or colostomy
- Patient with total colectomy
- Women that are pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leucine-rich α2-glycoproteinLeucine-rich α2-glycoprotein measurement | Diagnostic test | patient with IBD |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease (CD) and Ulcerative Colitis (UC), run by Imelda GI Clinical Research Center at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Bossuyt (MD PhD, peter.bossuyt@imelda.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between LRG serum level and endoscopic disease activity in CD and UC (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.