Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2025-12-24 @ 5:55 PM
NCT ID:
NCT05578768
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT05578768
Study Brief:
Protocol Section:
NCT05578768