An observational study in IBD and Inflammatory Bone Disease, sponsored by Leiden University Medical Center. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-13.
Sponsored by Leiden University Medical Center · Observational
The proposed study will use a PROM (Patient report Outcome Measurement)-tool in combination with clinical and biochemical data to train and validate a Relapse Prediction Model for individual patients.
The primary objective is to train and validate a relapse prediction model for individual patients available for daily (remote) care management. Besides that, risk-based care pathways for different prediction outcomes will be evaluated, prediction scores will be correlated to medication type, CRP/Calprotectin and/or endoscopy, and with known IBD clinical risk profiles. Moreover dietary intake will be correlated with the IBD risk profiles.
Study design: Multicentre, retrospective analysis of two prospective cohorts. Study population: Adult IBD patients. Main study parameters/endpoints: The endpoint will be a prediction regarding step-up or step-down in the care pathways. In other words, the percentage of patients in each individual care pathway with agreement between risk score of the individual patient and actual flares during a follow-up time of 24 months. Furthermore insight will be gained in dietary patterns amongst patients with different IBD risk profiles.
No benefits or risks are associated with participating in this study, because only standard of care is given.
11 studies on the registry are indexed under Osteitis; 1 is open to participants now.
Browse Osteitis studies →Leiden University Medical Center is the lead sponsor of 334 studies on the registry; 110 are open to participants now.
Counted across the registry records on this site, refreshed daily.
In clinical practice, consecutive IBD patients in the LUMC, AH, and MH are registered on the platform and will be asked to participate in the current project. At least 200 UC patients and at least 200 CD patients will be included. Following inclusion, each patient will spend at least 12, but preferably 24 months on the platform.
Patients are already using the PROM-tool to allow remote monitoring; this has been implemented since 2021.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study procedures for both cohorts are the same.
Other: No intervention
The study procedures for both cohorts are the same.
Other: No intervention
Patients will receive standard of care.
Develop a relapse prediction model for individual patients (agreement between risk score of the individual patient and actual flares) based on both clinical parameters and biochemical parameters in the individual care pathways.
This model will be based on both clinical parameters and biochemical parameters in the individual care pathways.
Time frame: After 2 years
Validate the above mentioned prediction model and make it available for daily (remote) care management.
Based on the information form the validation cohort. The model will be validated retrospectively.
Time frame: After 2 years
evaluate risk-based care pathways for different prediction outcomes in clinical practice e.g. high intensity monitoring care pathway for patients with a high prediction score.
Evaluate whether predefined risk-based care pathways are in line with prediction outcomes of the relapse prediction model.
Time frame: After 2 years
Correlate the prediction scores of the different care pathways to medication type.
See if there is a statistical correlation between medication type and prediction score
Time frame: After 2 years
Correlate prediction scores of the different pathways with biomarkers CRP/Calprotectin and/or endoscopy
See if there is a statistical correlation between prediction score and biomarkers CRP/Calprotectin and/or endoscopy
Time frame: After 2 years
Correlate prediction scores from the algorithm with known IBD clinical risk factors
See if there is a statistical correlation between prediction scores from the model to known clinical risk factors like e.g. operation history, presence of EIM.
Time frame: After 2 years
Correlate dietary intake with the assigned IBD clinical risk profiles
See if there is a statistical correlation between dietary intake and assigned IBD clinical risk profile.
Time frame: After 2 years
Started Oct 2022 (actual). Primary completion is estimated for Sep 2025, 34 months after the start.
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