Crohn Disease, IBD, Ulcerative Colitis
Conditions
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).
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).
Interventions
PROCEDUREbioespecimen samples
Blood, serum, plasma, urine, stools, small/large bowel tissue.
Sponsors
Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Patients from cohort A will be included if they fulfill all the following 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. Patients from cohort B will be included if they fulfill all the following inclusion criteria: * 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. Patients from cohort C will be included if they fulfill all the following inclusion criteria: * 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
Patients from cohort A will be excluded if they fulfill any the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease progression | 10 years | Development and type of new-onset symptoms during follow-up (mainly diarrhea, abdominal pain, and rectal bleeding). |
| - IBD characteristics | 10 years | * Type (CD or UC) * Disease extent (CD or UC) according to Montreal classification * CD phenotype at diagnosis (Montreal classification) * Endoscopic characteristics at diagnosis (both CD and UC): type of lesions, distribution, and extent * Presence and type (simple, complex fistula or abscess) of perianal disease at diagnosis and during follow-up |
| Omic findings | 10 years | proteomic, transcriptomic, serologic, microbiota, and tissue data |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IBD characteristics: | 10 years | * Development and time to development of changes in CD disease location, according to Montreal classification. * Development and time to development of new-onset or stricturing, penetrating or perianal complications, defined as changes in CD phenotype (Montreal classification) * Development of proximal disease extension in UC * Laboratory parameters: FOBT levels at diagnosis, and CRP, hemoglobin, albumin, fecal calprotectin at diagnosis and during follow-up. |
| Changes in endoscopic features during follow-up | 10 years | — |
| Microscopic characteristics at diagnosis | 10 years | — |
| Clinical disease activity during follow-up | 10years | — |
| Development and time to development of need for medical or surgical therapy during follow-up | 10years | — |
| Development and time to development of extraintestinal manifestations during follow-up | 10years | — |
| Type of extraintestinal manifestations during follow-up | 10years | — |
Countries
Spain
Contacts
CONTACTErika Araya, PhD
CONTACTIago Rodriguez Lago, MD
PRINCIPAL_INVESTIGATORIago Rodriguez Lago, MD
Spanish Working Group on Crohn's disease and ulcerative colitis (GETECCU)
Outcome results
None listed