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

NCT07316621 | Recruiting

• 1 other identifier: PREDICT-CD
• Study Type: observational
• Target: 10,000
• Locations: 6 countries
• Sites: 10

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.

Conditions

Crohn Disease (CD)

Outcome Measures

Primary Outcomes (1)

• Development of Crohn's disease during the study period

  Diagnosis confirmed according to established diagnostic criteria, specifically endoscopy and histopathology

  From enrolment until end of study follow-up (up to 3 years)

Secondary Outcomes (4)

• Proportion of first-degree relatives classified as high risk according to the PREDICT-CD risk prediction algorithm

  From enrolment until end of study follow-up (up to 3 years)

• Clinical and lifestyle characteristics of high-risk individuals who develop inflammatory bowel disease

  From enrolment until end of study follow-up (up to 3 years)

• Incidence of newly diagnosed immune-mediated inflammatory diseases other than Crohn's disease

  From enrolment until end of study follow-up (up to 3 years)

• Participant-reported willingness to receive predictive risk information and participate in preventive interventions

  From enrolment until end of study follow-up (up to 3 years)

Study Arms (1)

First-degree relatives

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The first-degree relative without a previous diagnosis of Inflammatory Bowel Disease

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• GLSMED Learning Health S.A.: lead

Study Sites (10)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

RECRUITING

AUMC

Amsterdam, Netherlands

RECRUITING

UMCG

Groningen, Netherlands

RECRUITING

Państwowy Instytut Medyczny MSWiA w Warszawie

Warsaw, Poland

RECRUITING

Hospital Beatriz Ângelo

Lisbon, Portugal

RECRUITING

Hospital da Luz Lisboa

Lisbon, Portugal

RECRUITING

Hospital dos Capuchos

Lisbon, Portugal

RECRUITING

Hospital Santa Maria

Lisbon, Portugal

RECRUITING

Hospital Galdakao-Usansolo

Galdakao, Spain

RECRUITING

Örebro University Hospital

Örebro, Sweden

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Ana F Raimundo, PhD

CONTACT

+351 926139262; intercept@hospitaldaluz.pt

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: January 5, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); NL (2); PL (1); IT (1); PT (4); SE (1)