NCT03571373 PIBD-SETQuality: the Inception Cohort and Safety Registry
| NCT ID | NCT03571373 |
| Status | Recruiting |
| Phase | — |
| Sponsor | PIBD-Net |
| Condition | Inflammatory Bowel Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,500 participants |
| Start Date | 2017-01-03 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,500 participants in total. It began in 2017-01-03 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frank Ruemmele, MD, PhD
✉ frank.ruemmele@nck.aphp.frLissy de Ridder, MD, PhD
PRINCIPAL INVESTIGATOR
Erasmus Medical Center
Frequently Asked Questions
Who can join the NCT03571373 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, up to 19 Years, studying Inflammatory Bowel Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03571373 currently recruiting?
Yes, NCT03571373 is actively recruiting participants. Contact the research team at frank.ruemmele@nck.aphp.fr for enrollment information.
Where is the NCT03571373 trial being conducted?
This trial is being conducted at Rotterdam, Netherlands, London, United Kingdom.
Who is sponsoring the NCT03571373 clinical trial?
NCT03571373 is sponsored by PIBD-Net. The principal investigator is Lissy de Ridder, MD, PhD at Erasmus Medical Center. The trial plans to enroll 1,500 participants.