PIBD-SETQuality: the Inception Cohort and Safety Registry
Recruiting · NCT03571373 · Observational (researchers observe without assigning treatment) · Lead sponsor: Erasmus Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
No intervention
What this trial is about
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.
Who can take part
Age range
0 Years to 19 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
2 locations listed.
- Royal Hospital London - London, United Kingdom
- Erasmus MC - Sophia Children's Hospital - Rotterdam, Netherlands