Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05578768
Other study ID # nWMODIV2_2022020
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Withdrawn NCT04269720 - Biofeedback in Pediatric Inflammatory Bowel Disease N/A
Recruiting NCT04457934 - Effectiveness of PLENVU in the General Screening Population and Patients With IBD
Completed NCT01369355 - A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease (IM-UNITI) Phase 3
Recruiting NCT06146816 - The Assessment of Infrared Treatment for Crohn's Disease N/A
Recruiting NCT05624801 - Cholecalciferol in Chronic Inflammatory Bowel Diseases Phase 3
Recruiting NCT03935451 - Postoperative Extended Venous Thromboprophylaxis in Inflammatory Bowel Disease Early Phase 1
Recruiting NCT05086562 - Prevalence of Chronic Abdominal Pain in Migraneurs
Completed NCT01653054 - Anal Dysplasia in Patients With Inflammatory Bowel Disease N/A
Completed NCT04131504 - Precision Crohn's Disease Management Utilizing Predictive Protein Panels (ENvISION)
Recruiting NCT03952364 - The PRECIOUS Study: Predicting Crohn's & ColitIs Outcomes in the United States
Enrolling by invitation NCT05414955 - Boom-IBD Clinical Trial N/A
Enrolling by invitation NCT04094324 - Mental Health in Children and Youth Within Pediatric Care
Suspended NCT04225819 - Adjunctive Treatment With Vitamin D3 in Patients With Active IBD N/A
Recruiting NCT03366090 - Immunological Profiles in Inflammatory Bowel Disease N/A
Completed NCT03750565 - Multiple Dose Ethnobridging PK Study in Healthy Subjects Phase 1
Recruiting NCT02970149 - Identifying a Sleep Screener for Disease Relapse in Children With Inflammatory Bowel Disease N/A
Completed NCT02622139 - Multispectral Optoacoustic Tomography (MSOT) for the Evaluation of Disease Activity in Inflammatory Bowel Diseases (IBD) N/A
Completed NCT02364973 - Combined PET-MRI in the Diagnostics of Chronic Inflammatory Bowel Diseases (IBD)- a Feasibility Study
Not yet recruiting NCT06090045 - Airway Involvement In Inflammatory Bowel Disease
Not yet recruiting NCT06089590 - Ibd CAncer and seRious Infections in France (I-CARE 2)