NCT07316621Recruiting
Prospective Risk Evaluation and Detection of Crohn's Disease in First-degree Relatives
Source: ClinicalTrials.gov · Last updated 29 Jul 2026
Brief summary (registry, in English)
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 study will be conducted within Work Package 3 (WP3) of the INTERCEPT project, a consortium funded by the Innovative Health Initiative (IHI). The research will take place across 28 centres in seven countries: Portugal, Spain, France, Italy, the Netherlands, Sweden, and Poland. To achieve the study objectives, individuals with Crohn's disease (referred to as patients) will be invited to participate and to engage their eligible first-degree relatives. At the baseline visit, the patient's physician will complete a clinical questionnaire covering disease history, treatments, and previous interventions. At the same time, first-degree relatives (parents, siblings, or children) will donate a blood sample for serum isolation and, optionally, a whole blood and stool sample. They will also complete a questionnaire regarding their health status, habits, and preferences. Follow-up questionnaires will be administered every six months to monitor the onset of symptoms or behavioural changes.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 10000 (estimated)
- First submitted
- 5 Dec 2025
- Start date
- 1 Apr 2026
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- GLSMED Learning Health S.A.
- Diseases
- Crohn's disease
- NCT number
- NCT07316621
What you commit to
- Study type: Observational
- Planned participants: 10000
- From 1 Apr 2026 to the primary completion date, 31 Dec 2029
- 10 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior diagnosis of IBD
Other illness
- Any legal or medical condition that limits the information and participation in the study
Lab values
- Participants unwilling or unable to donate blood for serum
Other
- Inability to verify CD diagnosis in the proband
- Participants unwilling or unable to provide informed written consent
Who the study is looking for
- 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.
Age in the registry: 16 years to 35 years · Sex: All · Accepts healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Galdakao-Usansolo Coordinator of this site? Confirm its status | Galdakao | Spain | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
| AUMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| UMCG Coordinator of this site? Confirm its status | Groningen | Netherlands | Recruiting |
| Państwowy Instytut Medyczny MSWiA w Warszawie Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Hospital Santa Maria Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| Hospital da Luz Lisboa Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| Hospital dos Capuchos Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| Hospital Beatriz Ângelo Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| Örebro University Hospital Coordinator of this site? Confirm its status | Örebro | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.