PIBD-SETQuality: the Inception Cohort and Safety Registry

Launched by PIBD-NET · Jun 26, 2018

Keywords

ClinConnect Summary

The PIBD-SETQuality trial is studying how effective and safe current treatments are for children and teenagers with inflammatory bowel diseases (IBD), such as Crohn's disease and ulcerative colitis, which are conditions that cause inflammation in the digestive system. The trial aims to gather information on patients who are newly diagnosed or have been diagnosed within the last two months. To be eligible for the study, participants need to be under 18 years old and must not have started any treatment for their IBD yet. Researchers will look at their medical history and test results to confirm their diagnosis.

If you or your child decides to participate, you can expect to provide information about your health and receive monitoring for any complications related to IBD. Your privacy will be respected, as personal details will not be shared in the safety reports. This study is currently recruiting participants, and it’s an opportunity to contribute to understanding how to better manage and treat IBD in young people.

Gender

ALL

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.