Immunological Characteristics of Preclinical IBD(EARLY)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate disease progression, in terms of development of symptomatic disease and complications associated with IBD (e.g. fistula, abscess, stricture).

Detailed Description
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This is a prospective, observational, multicenter, collaborative research project that will explore the earlier stages of IBD, before the onset of the first symptoms of the disease. This novel approach constitutes an innovative strategy on the research on the natural history of the disease. The study will be carried out based on colorectal cancer screening colonoscopies, recruiting all patients with a new diagnosis of IBD in this setting. These patients will undergo follow-up visits every 6 months for 10 years and the clinical information will be enriched with longitudinal multi-omic analyses. Two additional control groups will be identified, including patients with new-onset symptomatic IBD in the last 3 months and healthy controls (with normal screening colonoscopy).

Official Title
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Natural History and Immunological Characteristics of Preclinical Inflammatory Bowel Disease: a Nationwide, Prospective and Multicentric Study

Conditions
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IBD, Crohn Disease, Ulcerative Colitis

Intervention / Treatment
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* Procedure: bioespecimen samples


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: New diagnosis of IBD (UC or CD) during a colorectal cancer screening colonoscopy according to the European Crohn's and Colitis Organisation criteria Presence of a chronic inflammatory infiltrate and a histological diagnosis of IBD Patients with no prior or current gastrointestinal symptoms at diagnosis Time interval between the diagnosis (defined by the date of the colonoscopy) and the inclusion in the study less than 3 months Exclusion Criteria: Isolation of any enteropathogen Presence of acute inflammatory infiltrate with no signs of chronicity Prior diagnosis of microscopic colitis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort A (preclinical IBD)<br>asymptomatic patients with a new diagnosis of IBD during the colorectal cancer screening programme meeting all inclusion and none of the exclusion criteria (n=350). | Procedure: bioespecimen samples<br>* Blood, serum, plasma, urine, stools, small/large bowel tissue.<br>|
| Cohort B (control)<br>new-onset symptomatic IBD (n=20) - patients with a symptomatic debut of IBD in the last 3 months, naïve to immunosuppressants and biologic agents. | Procedure: bioespecimen samples<br>* Blood, serum, plasma, urine, stools, small/large bowel tissue.<br>|
| Cohort C (control)<br>healthy controls (n=20): patients with a normal screening colonoscopy, with no signs of IBD after a detailed evaluation of the ileum and colon, will be included. | Procedure: bioespecimen samples<br>* Blood, serum, plasma, urine, stools, small/large bowel tissue.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease progression | in terms of development of symptomatic disease and complications associated with IBD (e.g. fistula, abscess, stricture). | from baseline to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proximal disease extensions in UC |  | 10 years | 
| Endoscopic disease activity |  | 10 years | 
| Changes in the disease extension according to the Montreal classification |  | 10 years | 
| Histologic findings at diagnosis and during follow-up endoscopic examinations |  | 10years |