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

N/ANot Yet RecruitingNCT07316621

GLSMED Learning Health S.A.10,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

10,000

Conditions

Crohn Disease (CD)

Eligibility

Sex: ALLMin age: 16 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Assess the performance of a risk model for at-risk population for CD

The model will integrate measures of predefined serum biomarkers of at-risk population (first degree relatives of CD patients) with clinical and lifestyle factors. The performance can than be assessed by the risk prediction of participants which are then diagnosed with CD.

Time frame: through study development, an average of 1-3 year

Secondary Outcomes

Prevalence of risk factors in FDRs developing IBD

Evaluation of early life risk factors, dietary and nutritional patterns, fatigue, stress, and physical exercise levels, smoking history and exposure to smoking, medical and surgical history, and medication history in FDRs developing IBD during the study through semestral questionnaires

Time frame: throughout the study, in average 1-3 years