Prediction of IBD Disease Activity in Individual Patients Based on PROMs and Clinical Data

IBD Clinical Trial

— PrePro  

Official title:

Prediction of IBD Disease Activity in Individual Patients Based on PROMs and Clinical Data

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05578768
• Other study ID #: nWMODIV2_2022020
• Status: Recruiting
• Start date: October 3, 2022
• Est. completion date: September 1, 2025

Study information

• Verified date: October 2022
• Source: Leiden University Medical Center
• Contact: L.J.M. Koppelman, Msc.
• Phone: 0031715297902
• Email: patientenibd[@]lumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult IBD patients

• Subjects willing and able to sign informed consent

• Own and are able to use a smart phone (Android or iOS)

Exclusion Criteria:

• Unwilling or unable to adhere to the protocol

• Unwilling or unable to adhere to the informed consent

• Age <18y

Related Conditions & MeSH terms

• Bone Diseases
• IBD
• Osteitis

Intervention

Other:
• No intervention
Patients will receive standard of care.

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Centre	Leiden	Zuid-Holland

Sponsors (3)

Lead Sponsor	Collaborator
Leiden University Medical Center	Alrijne Hospital, Maasstad Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	After 2 years
Primary	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.	After 2 years
Secondary	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.	After 2 years
Secondary	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	After 2 years
Secondary	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	After 2 years
Secondary	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.	After 2 years
Secondary	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.	After 2 years