See if relatives of Crohn's patients are at risk for developing Crohn's disease
Official title: Prospective Risk Evaluation and Detection of Crohn's Disease in First-degree Relatives
Run by GLSMED Learning Health S.A. · NCT07316621 · Data updated 2026-11-12
This study tests a risk score using blood biomarkers and lifestyle factors in first-degree relatives of people with Crohn's disease to see if it can predict who will develop the condition.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 16 Years to 35 Years |
| Sex | All |
| Enrollment | 10000 (estimated) |
| Sponsor | GLSMED Learning Health S.A. Academic / other |
| Locations | 10 sites (Roma and 9 other locations) |
| Status | Recruiting |
| Started | April 1, 2026 |
| Main results expected | December 31, 2029 |
| Study ends | December 31, 2029 |
| Registry record updated | July 29, 2026 |
| Trial ID | NCT07316621 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
First-degree relatives of Crohn's disease patients, aged 16–35, who have not been diagnosed with IBD and can provide informed consent and a blood sample.
✕Probably not a fit
Relatives who do not show elevated risk or who do not progress to Crohn's disease may not receive direct benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study evaluates a risk score designed to predict Crohn's disease in first-degree relatives aged 16 to 35 of patients with Crohn's. It is conducted across 28 centers in seven countries as part of the INTERCEPT project under the IHI. At baseline, a physician completes a clinical questionnaire about disease history and treatments, and eligible relatives provide serum samples after informed consent. The study focuses on validating whether the biomarker-based risk score can stratify future risk in this high-risk group. Interventions are not specified as this is an observational risk-detection effort.
Why it matters
Potential benefit: If successful, the risk score could help identify relatives at higher risk so they can be monitored or counseled for early signs.
How similar studies have gone: Prior work has shown that biomarker-based risk scores can stratify risk in high‑risk populations, though exact validation in this specific familial cohort is forthcoming.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female participants, between 16 and 35 years old * FDR (parent, full-siblings or offspring) from a patient with an established diagnosis of CD * Participants able to understand the information provided to them and to give written informed assent or consent for the study. Exclusion Criteria: * Prior diagnosis of IBD * Any legal or medical condition that limits the information and participation in the study * Inability to verify CD diagnosis in the proband * Participants unwilling or unable to provide informed written consent * Participants unwilling or unable to donate blood for serum
Where it's running
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy Recruiting -
Aumc
Amsterdam, Netherlands Recruiting -
Umcg
Groningen, Netherlands Recruiting -
Państwowy Instytut Medyczny MSWiA w Warszawie
Warsaw, Poland Recruiting -
Hospital Beatriz Ângelo
Lisbon, Portugal Recruiting -
Hospital da Luz Lisboa
Lisbon, Portugal Recruiting
Show 4 more locations
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Hospital dos Capuchos
Lisbon, Portugal Recruiting -
Hospital Santa Maria
Lisbon, Portugal Recruiting -
Hospital Galdakao-Usansolo
Galdakao, Spain Recruiting -
Örebro University Hospital
Örebro, Sweden Recruiting
Study contacts
- Study coordinator: Ana F Raimundo, PhD
- Email: intercept@hospitaldaluz.pt
- Phone: +351 926139262
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.