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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05698745
Other study ID # EARLY
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 1, 2024
Est. completion date May 1, 2038

Study information

Verified date March 2024
Source Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
Contact Gisela Castany Pla, Pharmacyst
Phone +34 674682070
Email secretariacientifica3@geteccu.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 450
Est. completion date May 1, 2038
Est. primary completion date May 1, 2028
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 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. Patients from cohort B will be excluded if they fulfill any the following exclusion criteria: - Previous use of immunomodulators or biologics for any condition. Patients from cohort C will be excluded if they fulfill any the following exclusion criteria: - Any gastrointestinal symptoms at baseline. - Previous use of immunomodulators or biologics for any condition.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
bioespecimen samples
Blood, serum, plasma, urine, stools, small/large bowel tissue.

Locations

Country Name City State
Spain Hospital General Universitario Dr. Balmis Alicante
Spain Hospital Universitario Germans Trias i Pujol Badalona Barcelona
Spain Hospital de Sant Joan Despí Moisès Broggi Barcelona
Spain Hospital Universitario de Basurto Bilbao
Spain Hospital Universitario de Burgos Burgos
Spain Hospital Universitario Reina Sofía Córdoba
Spain Hospital Universitario Donostia Donostia Gipuzkoa
Spain Hospital Universitario de Galdakao Galdakao Vizcaya
Spain Hospital Universitario de Cabueñes Gijón Asturias
Spain Hospital Universitario de Canarias La Laguna Santa Cruz De Tenerife
Spain Hospital Universitario de la Princesa Madrid
Spain Hospital Universitario La Paz Madrid
Spain Hospital Universitario Ramon y Cajal Madrid
Spain Althaia, Xarxa Assistencial Universitària de Manresa Manresa Barcelona
Spain Complejo Hospitalario Universitario de Ourense Ourense
Spain Hospital Universitario Central de Asturias Oviedo Asturias
Spain Hospital Universitario Marqués de Valdecilla Santander Cantabria
Spain Hospital Clínico Universitario de Santiago Santiago De Compostela A Coruña
Spain Hospital Universitari Mútua de Terrassa Terrassa Barcelona
Spain Hospital Univeristario y Politécnico La Fe Valencia
Spain Hospital Universitario Clínico de Valencia Valencia
Spain Hospital Universitario Río Hortega Valladolid
Spain Hospital Álvaro Cunqueiro (Complejo Hospitalario Universitario de Vigo) Vigo Pontevedra
Spain Hospital Clínico Universitario Lozano Blesa Zaragoza
Spain Hospital Universitario Miguel Servet Zaragoza

Sponsors (1)

Lead Sponsor Collaborator
Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Disease progression Development and type of new-onset symptoms during follow-up (mainly diarrhea, abdominal pain, and rectal bleeding). 10 years
Primary Disease progression Time to development of symptomatic disease during follow-up. 10 years
Primary - IBD characteristics 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
10 years
Primary Omic findings proteomic, transcriptomic, serologic, microbiota, and tissue data 10 years
Secondary IBD characteristics: 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.
10 years
Secondary Changes in endoscopic features during follow-up 10 years
Secondary Microscopic characteristics at diagnosis 10 years
Secondary Clinical disease activity during follow-up 10years
Secondary Development and time to development of need for medical or surgical therapy during follow-up 10years
Secondary Development and time to development of extraintestinal manifestations during follow-up 10years
Secondary Type of extraintestinal manifestations during follow-up 10years
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