Immunological Characteristics of Preclinical IBD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-01

Study Completion Date

2038-07-01

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).

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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).

Conditions

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Crohn Disease Ulcerative Colitis IBD

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort A (preclinical IBD)

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).

bioespecimen samples

Intervention Type PROCEDURE

Blood, serum, plasma, urine, stools, small/large bowel tissue.

Cohort B (control)

new-onset symptomatic IBD (n=80) - patients with a symptomatic debut of IBD in the last 3 months, naïve to immunosuppressants and biologic agents.

bioespecimen samples

Intervention Type PROCEDURE

Blood, serum, plasma, urine, stools, small/large bowel tissue.

Cohort C (control)

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.

bioespecimen samples

Intervention Type PROCEDURE

Blood, serum, plasma, urine, stools, small/large bowel tissue.

Interventions

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bioespecimen samples

Blood, serum, plasma, urine, stools, small/large bowel tissue.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Male or female ≥18 years of age at baseline.
* New diagnosis of IBD during a CRC screening colonoscopy, based on the criteria from the European Crohn's and Colitis Organization (33, 34).
* Presence of a chronic inflammatory infiltrate and histological diagnosis compatible with IBD.
* The patient must be asymptomatic at diagnosis and without previous symptoms suggestive of IBD.
* Time interval between the index colonoscopy and the baseline visit up to 3 months.

* Male or female ≥18 years of age at baseline.
* Recent diagnosis of IBD, with \<3 months from symptoms onset.
* Time interval between the index colonoscopy and the baseline visit up to 3 months.

* Male or female ≥18 years of age at baseline.
* No endoscopic signs of IBD after a complete ileo-colonoscopy within the CRC screening program.
* Time interval between the index colonoscopy and the baseline visit up to 3 months.

Exclusion Criteria

* Identification of any enteropathogen in the stool culture.
* Isolated findings of acute inflammatory infiltrate without signs of chronicity.
* Previous or current diagnosis of microscopic colitis.
* Alteration in biomarkers in blood or stool will not constitute an exclusion criterion.

\- Previous use of immunomodulators or biologics for any condition.

* Any gastrointestinal symptoms at baseline.
* Previous use of immunomodulators or biologics for any condition.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Iago Rodriguez Lago, MD

Role: PRINCIPAL_INVESTIGATOR

Spanish Working Group on Crohn's disease and ulcerative colitis (GETECCU)

Locations

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Hospital Clínico Universitario de Santiago

Santiago de Compostela, A Coruña, Spain

Site Status RECRUITING

Hospital General Universitario Dr. Balmis

Alicante, Alicante, Spain

Site Status RECRUITING