Prospective Risk Evaluation and Detection of Crohn's Disease in First-degree Relatives
Observational · No treatment assigned · 10 sites · GLSMED Learning Health S.A.
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Crohn Disease (CD). This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 16 to 35
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- 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.
There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 10000 participants are expected to take part.
- Start date: 2026-04-01.
- Main results expected around 2029-12-31 (estimate from the record).
- 10 study sites listed (10 marked recruiting) in Italy, Netherlands, Poland, Portugal and Spain and 1 more countries.
Main thing being measured
- Development of Crohn's disease during the study period (From enrolment until end of study follow-up (up to 3 years))
In the researchers’ words
The PREDICT-CD study aims to validate a risk score for the development of Crohn's disease, based on serological biomarkers and lifestyle-related factors. Given that having a family member with the disease is the strongest known risk factor, the target population will consist of first-degree relatives (aged 16 to 35) of individuals diagnosed with Crohn's disease.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Crohn Disease (CD) |
| Lead sponsor | GLSMED Learning Health S.A. |
| Enrollment | 10000 (estimated) |
| Start date | 2026-04-01 |
| Primary completion (est.) | 2029-12-31 |
| First posted | 2026-01-05 |
| Last updated | 2026-07-29 |
| Official title | Prospective Risk Evaluation and Detection of Crohn's Disease in First-degree Relatives |
| ClinicalTrials.gov ID | NCT07316621 |
Interventions
- None listed
Full eligibility criteria (from the record)
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
Locations (10)
| Site | City | Country | Site status |
|---|---|---|---|
| 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 |
| Hospital dos Capuchos | Lisbon | Portugal | Recruiting |
| Hospital Santa Maria | Lisbon | Portugal | Recruiting |
| Hospital Galdakao-Usansolo | Galdakao | Spain | Recruiting |
| Örebro University Hospital | Örebro | Sweden | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.