Crohn'sUCRecruiting
PIBD-SETQuality: the Inception Cohort and Safety Registry
Observational · No treatment assigned · 2 sites · Erasmus Medical Center
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Inflammatory Bowel Diseases, Crohn Disease and Ulcerative Colitis. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 0 to 19
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- Newly diagnosed patient, <18 years of age, with a likely diagnosis of IBD or a confirmed diagnosis of IBD can be included in the study. In order to be eligible to continue in the study the subject must meet all of the following criteria:
- Diagnosis is based on history, physical examination, laboratory, endoscopic, radiological and histological features according to the revised Porto criteria (1)
- Diagnosis has been made or is confirmed within 2 months of inclusion
Plus 4 more requirement(s). There are also 3 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 1500 participants are expected to take part.
- Start date: 2017-01-03.
- Main results expected around 2030-12-31 (estimate from the record).
- 2 study sites listed (2 marked recruiting) in Netherlands and United Kingdom.
Main thing being measured
- Predictors for outcome and treatment response or non-response (Over a period of three years after inclusion of the last patient.)
In the researchers’ words
The purpose of this study is to analyse effectiveness and safety signals of current treatment strategies in routine practice for patients with pediatric-onset inflammatory bowel disease (PIBD) and to correlate this to their individual risk factors.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis |
| Lead sponsor | Erasmus Medical Center |
| Collaborators | European Commission; Queen Mary University of London; Hôpital Necker-Enfants Malades, Paris |
| Enrollment | 1500 (estimated) |
| Start date | 2017-01-03 |
| Primary completion (est.) | 2030-12-31 |
| First posted | 2018-06-27 |
| Last updated | 2026-08-11 |
| Official title | Paediatric Inflammatory Bowel Diseases Network for Safety, Efficacy, Treatment and Quality Improvement of Care: The PIBD-NET Inception Cohort and Safety Registry |
| ClinicalTrials.gov ID | NCT03571373 |
Interventions
- No intervention (Other)
No intervention due to the observational set-up of this study.
Full eligibility criteria (from the record)
Inclusion Criteria Inception cohort: Newly diagnosed patient, <18 years of age, with a likely diagnosis of IBD or a confirmed diagnosis of IBD can be included in the study. In order to be eligible to continue in the study the subject must meet all of the following criteria: * Diagnosis is based on history, physical examination, laboratory, endoscopic, radiological and histological features according to the revised Porto criteria (1) * Diagnosis has been made or is confirmed within 2 months of inclusion * Data on all diagnostic procedures are available for inclusion in the database * Informed consent of patient (if indicated) and parents has been obtained * Concerning the patients of whom biological specimens will be included: patients have not started IBD treatment yet Inclusion Criteria Safety Registry: Any child with IBD <19 years old with complications as detailed in the agreed safety monitoring list (or future updates of the list of conditions) can be reported. For the initial reporting of incident cases no patient identifiable details will be required. Exclusion Criteria Inception cohort: * Inability to read and understand the patient and family information sheets (for example insufficient knowledge of national language, where no health advocate or family member is available to translate and ensure full understanding of the study) * Informed consent of patient or parents has not been obtained when required * Patients on similar treatments as for IBD but for other conditions, or known with conditions directly affecting the IBD (e.g. immunodeficiency or major gastrointestinal resections) Exclusion Criteria Safety registry: none.
Locations (2)
| Site | City | Country | Site status |
|---|---|---|---|
| Erasmus MC - Sophia Children's Hospital | Rotterdam | Netherlands | Recruiting |
| Royal Hospital London | London | United Kingdom | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.