Immunological Characteristics of Preclinical IBD

Sponsor
Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
Study ID
NCT05698745
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • bioespecimen samples — PROCEDURE
    Blood, serum, plasma, urine, stools, small/large bowel tissue.

Study Details

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).

Key Dates

Start date
Jun 1, 2024
Status verified
Apr 2026
Primary completion
Jul 1, 2026
Completion
Jul 1, 2038

Study Design

Enrollment
450 participants (estimated)

Arms

  • Arm: 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).
  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Disease progression [ Time Frame: 10 years ]

Central Contacts

Related Studies