EARLY: Natural History and Immunological Characteristics of Preclinical IBD: a Nationwide, Prospective and Multicentric Study
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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). |
Procedure: bioespecimen samples
genetics Serology proteomics Single-cell RNA Hematology Biomarkers metabolome Biopsy microbiota
|
| Cohort B (control) 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
genetics Serology proteomics Single-cell RNA Hematology Biomarkers metabolome Biopsy microbiota
|
| 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. |
Procedure: bioespecimen samples
genetics Serology proteomics Single-cell RNA Hematology Biomarkers metabolome Biopsy microbiota
|
Outcome Measures
Primary Outcome Measures
- Disease progression [from baseline to 10 years]
in terms of development of symptomatic disease and complications associated with IBD (e.g. fistula, abscess, stricture).
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Galdakao | Galdakao | Bizcaia | Spain | 48960 |
Sponsors and Collaborators
- Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
Investigators
- Principal Investigator: Iago Rodriguez, MD, Spanish Working Group on Crohn's disease and ulcerative colitis (GETECCU)
Study Documents (Full-Text)
None provided.More Information
Publications
- Rodriguez-Lago I, Merino O, Azagra I, Maiz A, Zapata E, Higuera R, Montalvo I, Fernandez-Calderon M, Arreba P, Carrascosa J, Iriarte A, Portillo I, Aguirre U, Barreiro-de Acosta M, Munoz-Navas M, Cabriada JL. Characteristics and Progression of Preclinical Inflammatory Bowel Disease. Clin Gastroenterol Hepatol. 2018 Sep;16(9):1459-1466. doi: 10.1016/j.cgh.2017.11.006. Epub 2017 Nov 11.
- Rodriguez-Lago I, Ramirez C, Merino O, Azagra I, Maiz A, Zapata E, Higuera R, Montalvo I, Fernandez-Calderon M, Arreba P, Carrascosa J, Iriarte A, Munoz-Navas M, Cabriada JL, Barreiro-de Acosta M. Early microscopic findings in preclinical inflammatory bowel disease. Dig Liver Dis. 2020 Dec;52(12):1467-1472. doi: 10.1016/j.dld.2020.05.052. Epub 2020 Jun 26.
- EARLY