Argentina registry for people with Crohn's disease and ulcerative colitis.
Argentine Registry of Crohn's Disease and Ulcerative Colitis
Collects routine care information from people of all ages in Argentina who have Crohn's disease or ulcerative colitis to track treatments, complications, and outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 4250 (estimated) |
| Sex | All |
| Sponsor | Grupo Argentino de Enfermedad de Crohn y Colitis Ulcerosa Academic / other |
| Locations | 1 site (Córdoba, Córdoba Province) |
| Trial ID | NCT07155148 on ClinicalTrials.gov |
What this trial studies
RADECCU is a national, observational registry that captures standardized demographic, clinical, diagnostic, treatment, and outcome data from pediatric and adult patients with Crohn's disease or ulcerative colitis treated by members of the Argentine Crohn's and Ulcerative Colitis Group (GADECCU). Data are entered into a web platform supported by a technical team and managed by an executive, scientific, and methodological committee. The registry records safety events (including infections), access-to-care measures, and treatment effectiveness outcomes such as flares, hospitalizations, and surgeries. Each participating center obtained local ethics approval and follows applicable regulatory and data protection requirements.
Who should consider this trial
Good fit: Any patient of any age in Argentina with a confirmed diagnosis of Crohn's disease or ulcerative colitis based on validated clinical, endoscopic, laboratory, histopathologic, or imaging criteria is eligible.
Not a fit: Patients with only a suspected but unconfirmed diagnosis, or those with incomplete information about therapy and follow-up, are excluded and unlikely to benefit directly from participation.
Why it matters
Potential benefit: If successful, the registry could improve understanding of real-world treatment effectiveness and safety and help guide clinical care and health policy for IBD in Argentina.
How similar studies have performed: Other national and regional IBD registries have successfully provided real-world evidence on safety, treatment patterns, and outcomes, so this approach is established rather than entirely novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Any patient diagnosed with IBD defined by validated diagnostic criteria can be included into the registry. The criteria for IBD diagnosis were based on previously published criteria for IBD diagnosis, including clinical, endoscopic, laboratory, and histopathological aspects, as well as small bowel imaging studies Exclusion Criteria: * Suspected IBD diagnosis without confirmation * IBD patients with incomplete information about therapy and follow-up
Where this trial is running
Córdoba, Córdoba Province
- Hospital Privado Universitario de Cordoba — Córdoba, Córdoba Province, Argentina (Recruiting)
Study contacts
- Principal investigator: Domingo C Balderramo, MD, PhD — Grupo Argentino de Enfermedad de Crohn y Colitis Ulcerosa
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.