RecruitingNCT07316621

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


Sponsor

GLSMED Learning Health S.A.

Enrollment

10,000 participants

Start Date

Apr 1, 2026

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 16 YearsMax Age: 35 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a new treatment for people with crohn disease (cd). The study is currently recruiting participants at 10 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(10)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

AUMC

Amsterdam, Netherlands

UMCG

Groningen, Netherlands

Państwowy Instytut Medyczny MSWiA w Warszawie

Warsaw, Poland

Hospital Beatriz Ângelo

Lisbon, Portugal

Hospital da Luz Lisboa

Lisbon, Portugal

Hospital dos Capuchos

Lisbon, Portugal

Hospital Santa Maria

Lisbon, Portugal

Hospital Galdakao-Usansolo

Galdakao, Spain

Örebro University Hospital

Örebro, Sweden

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NCT07316621


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