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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First-degree relatives |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | through study development, an average of 1-3 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | throughout the study, in average 1-3 years |
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Inclusion Criteria:
Exclusion Criteria:
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The first-degree relative without a previous diagnosis of Inflammatory Bowel Disease
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ana F Raimundo, PhD | Contact | +351 926139262 | intercept@hospitaldaluz.pt |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| D007410 | Intestinal Diseases |