ClinicalTrials.gov
Cure8 trial brief
Why This Matters
This study aims to identify which clinical or biological factors predict treatment response and serious complications in children with newly diagnosed IBD — information that could help tailor care for pediatric patients in the future.
The attached safety registry is intended to capture rare but serious complications in pediatric IBD that individual centers may not see often.
Who Should Pay Attention
Pediatric IBD patients and their families, pediatric gastroenterologists and IBD clinicians, and researchers interested in PIBD outcomes, safety, and prognostic biomarkers.
Study Snapshot
Story typeClinical Reference
Evidence typeClinical trial
Enrollment1,500 participants
Study statusRecruiting
Source depthTrial registry record
What To Know
This trial record describes PIBD-SETQuality, a prospective observational inception cohort plus safety registry enrolling children and adolescents with newly diagnosed pediatric-onset IBD to study treatment effectiveness, predictors of response, and rare/severe complications.
The inception cohort will follow newly diagnosed patients (up to age 18/19 depending on arm) to collect baseline and 12-week data to identify factors predictive of outcomes (including fibrostricturing disease, penetrating disease, active perianal fistula/abscess, and need for surgery).
The safety registry collects incident and prevalent cases of specified complications to estimate their incidence and better characterize disease and treatment features. Recruitment is listed as ongoing with planned enrollment ~1500 across sites including Erasmus MC and Royal Hospital London.
This summary is grounded in the trial registry record; it describes the study design and aims but does not report results or imply effectiveness of any treatments.
Keep In Mind
This is an observational, non-interventional registry and inception cohort (not a treatment trial). The record is a trial registry entry describing planned data collection and aims; it does not provide results. Outcomes are prospective and will require follow-up to produce findings.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorErasmus Medical Center
Trial IDNCT03571373
Study typeObservational
Enrollment1,500 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedAug 11, 2026, 12:00 AM
Content availableTrial registry record
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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