Prospective Risk Evaluation and Detection of Crohn's Disease in First-degree Relatives (PREDICT-CD)

July 27, 2026 updated by: GLSMED Learning Health S.A.

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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Roma, Italy
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
        • Contact:
        • Principal Investigator:
          • Franco Scaldaferri, MD
  • Netherlands
      • Amsterdam, Netherlands
        • Recruiting
        • AUMC
        • Contact:
        • Principal Investigator:
          • Geert d'Haens, PhD
      • Groningen, Netherlands
        • Recruiting
        • UMCG
        • Contact:
        • Principal Investigator:
          • Rinse Weersma, PhD
  • Poland
      • Warsaw, Poland
        • Recruiting
        • Panstwowy Instytut Medyczny MSWiA w Warszawie
        • Contact:
        • Principal Investigator:
          • Grazyna grazyna.rydzewska@pimmswia.gov.pl, MD
  • Portugal
      • Lisbon, Portugal
        • Recruiting
        • Hospital Santa Maria
        • Contact:
        • Principal Investigator:
          • Sérgio Bronze, MD
      • Lisbon, Portugal
        • Recruiting
        • Hospital da Luz Lisboa
        • Contact:
        • Principal Investigator:
          • Joana Torres, PhD
      • Lisbon, Portugal
      • Lisbon, Portugal
  • Spain
      • Galdakao, Spain
        • Recruiting
        • Hospital Galdakao-Usansolo
        • Contact:
        • Principal Investigator:
          • Iago Rodriguez, PhD
  • Sweden
      • Örebro, Sweden
        • Recruiting
        • Örebro University Hospital
        • Contact:
        • Principal Investigator:
          • Jonas Halfvarsson

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
First-degree relatives

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of Crohn's disease during the study period
Time Frame: From enrolment until end of study follow-up (up to 3 years)
Diagnosis confirmed according to established diagnostic criteria, specifically endoscopy and histopathology
From enrolment until end of study follow-up (up to 3 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of first-degree relatives classified as high risk according to the PREDICT-CD risk prediction algorithm
Time Frame: From enrolment until end of study follow-up (up to 3 years)
Proportion of enrolled first-degree relatives whose calculated risk score exceeds the predefined threshold for high-risk classification, based on the PREDICT-CD risk prediction algorithm incorporating serological biomarkers and lifestyle/environmental risk factors.
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
Time Frame: From enrolment until end of study follow-up (up to 3 years)

Characterization of high-risk participants who develop incident inflammatory bowel disease during follow-up, including:

time from study enrolment to diagnosis; disease phenotype and disease behaviour at diagnosis; disease severity at diagnosis; early-life risk factors; dietary, nutritional and lifestyle factors; smoking exposure; medical and surgical history.
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
Time Frame: From enrolment until end of study follow-up (up to 3 years)
Number and proportion of participants diagnosed with a new immune-mediated inflammatory disease other than Crohn's disease during study follow-up, based on investigator-confirmed clinical diagnoses.
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
Time Frame: From enrolment until end of study follow-up (up to 3 years)
Acceptability will be assessed using a study-specific participant questionnaire. The questionnaire will evaluate willingness to receive information regarding Crohn's disease risk, willingness to undergo additional monitoring, willingness to participate in disease-interception or prevention studies, and concerns and preferences related to predictive testing. Responses will be recorded as categorical and Likert-scale measures and summarized descriptively.
From enrolment until end of study follow-up (up to 3 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GLSMED Learning Health S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2026

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

December 5, 2025

First Submitted That Met QC Criteria

December 18, 2025

First Posted (Actual)

January 5, 2026

Study Record Updates

Last Update Posted (Actual)

July 29, 2026

Last Update Submitted That Met QC Criteria

July 27, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREDICT-CD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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