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Clinical Trials in Italy / NCT07316621
Recruiting Observational

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

NCT07316621 · tracked via the Priya Life Science Italy tracker
Sponsor
GLSMED Learning Health S.A
Phase
Observational
Started
2026-04-01
Last updated
2026-07-29

Condition(s) studied

Crohn Disease (CD)

Study 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.

Eligibility

Sex
ALL
Min age
16 Years
Max age
35 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (10)

FacilityCityRegionStatus
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

More GLSMED Learning Health S.A. trials in Italy

The CROCO Study: CROhn's Disease COhort Study Active, not recruiting

Other trials for the same condition

Ex Vivo Comparison Of Combination Versus Single Therapeutic Pathway Inhibition In Human Intestinal Mucosa From Patients With Inflammatory Bowel Disease Starting soon
Study on Eating Habits and Association with "omic" Profiles in Families with a Subject Affected by a Chronic Immune-mediated Inflammatory Pathology. Observational Multicenter Study. Recruiting
Comparison Between Artificial Intelligence and Standard Reading to Investigate Suspected Crohn Disease: the SCAI STUDY Recruiting
Impact of Exclusion Diet in Addition to Anti-TNF Therapy in Crohn's Disease and Ulcerative Colitis: a Prospective, Randomized, Double-arm, Open-label Study Recruiting
The Microbial Impact on Intestinal Fibrosis and the Associated Immune Microenvironment in Crohn's Disease Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07316621 on ClinicalTrials.gov ↗ ← All trials in Italy