Crohn's Disease Clinical Trials

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Prospective Study of the Natural History, Immunological and Genetic Characteristics of Preclinical Inflammatory Bowel Disease

Status: Recruiting
Location: See all (25) locations...
Intervention Type: Procedure
Study Type: Observational
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ 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.

Locations
Other Locations
Spain
Hospital General Universitario Dr. Balmis
RECRUITING
Alicante
Hospital Universitario Germans Trias i Pujol
NOT_YET_RECRUITING
Badalona
Hospital de Sant Joan Despí Moisès Broggi
RECRUITING
Barcelona
Hospital Universitario de Basurto
RECRUITING
Bilbao
Hospital Universitario de Burgos
NOT_YET_RECRUITING
Burgos
Hospital Universitario Reina Sofía
NOT_YET_RECRUITING
Córdoba
Hospital Universitario Donostia
NOT_YET_RECRUITING
Donostia / San Sebastian
Hospital Universitario de Galdakao
RECRUITING
Galdakao
Hospital Universitario de Cabueñes
RECRUITING
Gijón
Hospital General Universitario Gregorio Marañón
ACTIVE_NOT_RECRUITING
Madrid
Hospital Universitario de la Princesa
NOT_YET_RECRUITING
Madrid
Hospital Universitario La Paz
NOT_YET_RECRUITING
Madrid
Hospital Universitario Ramon y Cajal
NOT_YET_RECRUITING
Madrid
Althaia, Xarxa Assistencial Universitària de Manresa
NOT_YET_RECRUITING
Manresa
Complejo Hospitalario Universitario de Ourense
NOT_YET_RECRUITING
Ourense
Hospital Universitario Central de Asturias
NOT_YET_RECRUITING
Oviedo
Hospital Universitario de Canarias
NOT_YET_RECRUITING
San Cristóbal De La Laguna
Hospital Clínico Universitario de Santiago
RECRUITING
Santiago De Compostela
Hospital Universitari Mútua de Terrassa
NOT_YET_RECRUITING
Terrassa
Hospital Univeristario y Politécnico La Fe
NOT_YET_RECRUITING
Valencia
Hospital Universitario Clínico de Valencia
NOT_YET_RECRUITING
Valencia
Hospital Universitario Río Hortega
NOT_YET_RECRUITING
Valladolid
Hospital Álvaro Cunqueiro (Complejo Hospitalario Universitario de Vigo)
NOT_YET_RECRUITING
Vigo
Hospital Clínico Universitario Lozano Blesa
NOT_YET_RECRUITING
Zaragoza
Hospital Universitario Miguel Servet
NOT_YET_RECRUITING
Zaragoza
Contact Information
Primary
Erika Araya, PhD
secretariacientifica3@geteccu.org
+34 674682070
Backup
Iago Rodriguez Lago, MD
iago.r.lago@gmail.com
+34 674682070
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2038-07-01
Participants
Target number of participants: 450
Treatments
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).
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.
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.
Sponsors
Leads: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

This content was sourced from clinicaltrials.gov