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NCT07316621Recruiting

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

Source: ClinicalTrials.gov · Last updated 29 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
10000 (estimated)
First submitted
5 Dec 2025
Start date
1 Apr 2026
Primary completion date
31 Dec 2029
Lead sponsor
GLSMED Learning Health S.A.
NCT number
NCT07316621

What you commit to

  • Study type: Observational
  • Planned participants: 10000
  • From 1 Apr 2026 to the primary completion date, 31 Dec 2029
  • 10 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior diagnosis of IBD

Other illness

  • Any legal or medical condition that limits the information and participation in the study

Lab values

  • Participants unwilling or unable to donate blood for serum

Other

  • Inability to verify CD diagnosis in the proband
  • Participants unwilling or unable to provide informed written consent

Who the study is looking for

  • 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.

Age in the registry: 16 years to 35 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (10)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Galdakao-Usansolo
Coordinator of this site? Confirm its status
GaldakaoSpainRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Coordinator of this site? Confirm its status
RomaItalyRecruiting
AUMC
Coordinator of this site? Confirm its status
AmsterdamNetherlandsRecruiting
UMCG
Coordinator of this site? Confirm its status
GroningenNetherlandsRecruiting
Państwowy Instytut Medyczny MSWiA w Warszawie
Coordinator of this site? Confirm its status
WarsawPolandRecruiting
Hospital Santa Maria
Coordinator of this site? Confirm its status
LisbonPortugalRecruiting
Hospital da Luz Lisboa
Coordinator of this site? Confirm its status
LisbonPortugalRecruiting
Hospital dos Capuchos
Coordinator of this site? Confirm its status
LisbonPortugalRecruiting
Hospital Beatriz Ângelo
Coordinator of this site? Confirm its status
LisbonPortugalRecruiting
Örebro University Hospital
Coordinator of this site? Confirm its status
ÖrebroSwedenRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.