NCT07316621

Prospective Risk Evaluation and Detection of Crohn's Disease in First-degree Relatives

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: GLSMED Learning Health S.A. · Academic / Other
• Sex: All
• Age: 16 Years – 35 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Crohn Disease (CD)

Timeline

• Start date: 2026-01-01
• Primary completion: 2029-12-31
• Completion: 2029-12-31
• First posted: 2026-01-05
• Last updated: 2026-01-05