IBDPreProNCT05578768
Prediction of IBD Disease Activity in Individual Patients Based on PROMs and Clinical Data
An observational study of IBD and Inflammatory Bone Disease, run by Leiden University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IBD, Inflammatory Bone Disease
- How many people
- 400 participants
- Where
- 1 siteNetherlands
- Study dates
- 3 Oct 2022to 1 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Adult IBD patients
- Subjects willing and able to sign informed consent
- Own and are able to use a smart phone (Android or iOS)
Who cannot join
- Unwilling or unable to adhere to the protocol
- Unwilling or unable to adhere to the informed consent
- Age <18y
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University Medical Centre
Leiden, South Holland, 2300 RC
L.J.M. Koppelman, MSc, 0031715297902, patientenibd@lumc.nl
About this study
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.
Read the 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.
- Conditions
- IBD, Inflammatory Bone Disease
- Being tested
- No intervention
- Medical subject headings
- Osteitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Patients will receive standard of care.
| Study group | Role | What they receive |
|---|---|---|
| training phase | The study procedures for both cohorts are the same. Receives: Other: No intervention | |
| validation phase | The study procedures for both cohorts are the same. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: After 2 years
Secondary outcomes (5)
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: After 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start3 Oct 2022
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBDStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Alrijne Hospital, Maasstad Hospital
- Responsible party
- Principal investigator, Andrea E. van der Meulen - de Jong, MD, PhD, Leiden University Medical Center
- Investigators
- A.E. van der Meulen - de Jong, MD, PhD, Principal investigator, Leiden University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05578768
- Sponsor's protocol ID
- nWMODIV2_2022020
- Acronym
- PrePro
- Status last verified
- Oct 2022
- First submitted
- 17 Aug 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of IBD Disease Activity in Individual Patients Based on PROMs and Clinical Data
- ClinicalTrials.gov ID
- NCT05578768
- Acronym / sponsor ID
- PrePro / nWMODIV2_2022020
- Conditions
- IBD, Inflammatory Bone Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Alrijne Hospital, Maasstad Hospital
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| training phase | – | Other: No interventionThe study procedures for both cohorts are the same. |
| validation phase | – | Other: No interventionThe study procedures for both cohorts are the same. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- Adult IBD patients
- Subjects willing and able to sign informed consent
- Own and are able to use a smart phone (Android or iOS)
Key exclusion criteria (3 listed)
- Unwilling or unable to adhere to the protocol
- Unwilling or unable to adhere to the informed consent
- Age <18y
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionPatients will receive standard of care. | Other | training phase, validation phase |
Primary outcome
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.
Time frame: After 2 years
This model will be based on both clinical parameters and biochemical parameters in the individual care pathways.
Validate the above mentioned prediction model and make it available for daily (remote) care management.
Time frame: After 2 years
Based on the information form the validation cohort. The model will be validated retrospectively.
5 secondary outcomes
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.
Time frame: After 2 years
Correlate the prediction scores of the different care pathways to medication type.
Time frame: After 2 years
Correlate prediction scores of the different pathways with biomarkers CRP/Calprotectin and/or endoscopy
Time frame: After 2 years
Correlate prediction scores from the algorithm with known IBD clinical risk factors
Time frame: After 2 years
Correlate dietary intake with the assigned IBD clinical risk profiles
Time frame: After 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A.E. van der Meulen - de Jong, MD, PhD principal investigator
Leiden University Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IBD and Inflammatory Bone Disease, run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact L.J.M. Koppelman, Msc. (0031715297902, patientenibd@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: After 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.