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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16-35
SponsorGLSMED Learning Health S.A.

About this trial

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

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

10,000 Participants
are grouped into 1 trial group

Sponsors and collaborators