Immunological Characteristics of Preclinical IBD

Recruiting

• Conditions: Crohn Disease; Ulcerative Colitis; IBD
• Interventions: Procedure: bioespecimen samples

• Registration Number: NCT05698745
• Lead Sponsor: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

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).

Study Timeline

• Study First Submitted: 2023-01-10
• Study First Submitted QC: 2023-01-16
• Study First Posted: 2023-01-26
• Study Start: 2024-06-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-20
• Primary Completion: 2025-07-01
• Study Completion: 2038-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort A (preclinical IBD)	bioespecimen samples	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).
Cohort B (control)	bioespecimen samples	new-onset symptomatic IBD (n=80) - patients with a symptomatic debut of IBD in the last 3 months, naïve to immunosuppressants and biologic agents.
Cohort C (control)	bioespecimen samples	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.

Primary Outcome Measures

Name	Time	Method
Omic findings	10 years	proteomic, transcriptomic, serologic, microbiota, and tissue data
- 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
Disease progression	10 years	Time to development of symptomatic disease during follow-up.

Secondary Outcome Measures

Name	Time	Method
Development and time to development of need for medical or surgical therapy during follow-up	10years
Type of extraintestinal manifestations during follow-up	10years
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.
Microscopic characteristics at diagnosis	10 years
Changes in endoscopic features during follow-up	10 years
Clinical disease activity during follow-up	10years
Development and time to development of extraintestinal manifestations during follow-up	10years

Trial Locations

Locations (25)

Hospital Clínico Universitario de Santiago; 🇪🇸 Santiago De Compostela, A Coruña, Spain

Hospital Universitario de Cabueñes; 🇪🇸 Gijón, Asturias, Spain

Hospital Universitario Central de Asturias; 🇪🇸 Oviedo, Asturias, Spain

Hospital Universitario Marqués de Valdecilla; 🇪🇸 Santander, Cantabria, Spain

Hospital Universitario Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Althaia, Xarxa Assistencial Universitària de Manresa; 🇪🇸 Manresa, Barcelona, Spain

Hospital Universitari Mútua de Terrassa; 🇪🇸 Terrassa, Barcelona, Spain

Hospital General Universitario Dr. Balmis; 🇪🇸 Alicante, Spain

Hospital de Sant Joan Despí Moisès Broggi; 🇪🇸 Barcelona, Spain

Hospital Universitario Donostia; 🇪🇸 Donostia, Gipuzkoa, Spain

Hospital Universitario de Galdakao; 🇪🇸 Galdakao, Vizcaya, Spain

Hospital Álvaro Cunqueiro (Complejo Hospitalario Universitario de Vigo); 🇪🇸 Vigo, Pontevedra, Spain

Hospital Universitario de Canarias; 🇪🇸 La Laguna, Santa Cruz de Tenerife, Spain

Hospital Universitario de Basurto; 🇪🇸 Bilbao, Spain

Hospital Universitario de Burgos; 🇪🇸 Burgos, Spain

Hospital Universitario Reina Sofía; 🇪🇸 Córdoba, Spain

Hospital Universitario de la Princesa; 🇪🇸 Madrid, Spain

Hospital Universitario Ramon y Cajal; 🇪🇸 Madrid, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Complejo Hospitalario Universitario de Ourense; 🇪🇸 Ourense, Spain

Hospital Universitario Clínico de Valencia; 🇪🇸 Valencia, Spain

Hospital Univeristario y Politécnico La Fe; 🇪🇸 Valencia, Spain

Hospital Universitario Río Hortega; 🇪🇸 Valladolid, Spain

Hospital Clínico Universitario Lozano Blesa; 🇪🇸 Zaragoza, Spain

Hospital Universitario Miguel Servet; 🇪🇸 Zaragoza, Spain