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ClinicalTrials.gov ID

NCT07316621

Lead Sponsor

GLSMED Learning Health S.A.OTHER

Overall Status

Recruiting

Study Type

Observational

Enrollment

10,000Estimated

Last Update Posted

Jul 29, 2026Actual

Start Date

Apr 1, 2026Actual

Primary Completion Date

Dec 31, 2029Estimated

Completion Date

Dec 31, 2029Estimated

Official Title

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

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.

• Crohn Disease (CD)

Ages Eligible for Study

Child (0-17)Adult (18-64)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

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

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

GLSMED Learning Health S.A.OTHER

intercept.lab@amsterdamumc.nl(020) 566 9111

l.aboosy@umcg.nl+31 50 361 6161