PIBD-SETQuality: the Inception Cohort and Safety Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-19
SponsorErasmus Medical Center
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial population
Patients with paediatric-onset IBD (either Crohn's disease, ulcerative colitis or IBD-unclassified).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No intervention
Other interventionNo intervention due to the observational set-up of this study.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Predictors for outcome and treatment response or non-response
Factors predictive for outcome and treatment response or non-response This includes factors at baseline and 12 weeks after disease-onset that predict adverse outcomes (e.g. fibrostricturing disease, penetrating disease, active perianal fistula or abcess and need of surgery).
Time frame
Over a period of three years after inclusion of the last patient.Secondary outcomes
1
New biomarkers as classifiers of response or non-response to therapy
Part of the children in the inception cohort will deliver biological specimens to develop new biomarkers as classifiers of disease risk of complicated disease or side effects in PIBD patients, as well as predictors of (non-)response to a specific immunomodulator or biological agent.
Time frame
Over a period of three years after inclusion of the last patient.2
Identification of patients with rare and serious complications
Secondary outcome is to identify patients with rare and serious complications of PIBD or its treatment.
Time frame
Until the end of patients recruitment, for a period of 2 years.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Erasmus Medical Center
Lead sponsor
European Commission
Collaborator
Queen Mary University of London
Collaborator
Hôpital Necker-Enfants Malades, Paris
Collaborator
Source ClinicalTrials.gov