NCT07316621 Prospective Risk Evaluation and Detection of Crohn's Disease in First-degree Relatives
| NCT ID | NCT07316621 |
| Status | Recruiting |
| Phase | — |
| Sponsor | GLSMED Learning Health S.A. |
| Condition | Crohn Disease (CD) |
| Study Type | OBSERVATIONAL |
| Enrollment | 10,000 participants |
| Start Date | 2026-04-01 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10,000 participants in total. It began in 2026-04-01 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07316621 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 35 Years, studying Crohn Disease (CD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07316621 currently recruiting?
Yes, NCT07316621 is actively recruiting participants. Contact the research team at intercept@hospitaldaluz.pt for enrollment information.
Where is the NCT07316621 trial being conducted?
This trial is being conducted at Roma, Italy, Amsterdam, Netherlands, Groningen, Netherlands, Warsaw, Poland and 6 additional locations.
Who is sponsoring the NCT07316621 clinical trial?
NCT07316621 is sponsored by GLSMED Learning Health S.A.. The trial plans to enroll 10,000 participants.