Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
2 participants
OBSERVATIONAL
2022-02-08
2024-06-30
Brief Summary
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This prospective cohort study will enroll IBD patients assigned for biologic treatment. At baseline (Pre-treatment), biopsies and blood is taken from each patient. Follow-up will be conducted at week 14-16 after treatment initiation (according to the current Danish standards). Evaluation of a successful treatment outcome response will - for each disease - be based on most frequently used primary endpoints; the major outcome of the analyses will be to detect differences in treatment outcome between patients with the cell expression.
The overarching goal of this project is to improve the lives of patients suffering from IBD, by providing evidence to potential biomarkers that would be likely to improve the clinical outcome.
The study is approved by the local Ethics Committee (S-20160124) and the local Data Agency (2008-58-035). The study findings will be disseminated in peer-reviewed journals, via patient associations, and presented at national and international conferences.
Detailed Description
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Design: In this prospective cohort study disease activity prior to and after (14-16 weeks) initiation of biologic treatment will be assessed. The endpoint is the treatment outcome defined as A: Responder according to the specific criteria described below (incl. drug-continuation) or B: Non-responder (incl. drug-discontinuation due to unacceptable side effects). Whether a patient will discontinue therapy is assumed to be based on a certain degree of shared decision making between the patient and physician supported by principles from national guidelines for each patient as recommended in the respective national guidelines and laboratory data.
Setting: All patients assigned for initiation of biologic treatment at the Department of Medical Gastroenterology, Odense University Hospital from 1st of February 2022 and until 31th of December 2022 or until a minimum of 20 patients with IBD is achieved.
Clinical data consist of personal data, data on health and disease and disease activity scores. Information registered by clinicians and technicians will be transferred from paper format to electronic format using either double entry of data or automated forms processing.
Sample size considerations: We will include a limited set of patient biopsies from 20 UC patients and analyze the changes in responders versus non-responders for identifying potential predictive pathways and biomarkers. Such a strategy has recently been proven valuable for identification of biomarkers predictive of treatment response in CD with a similar number of samples as in our study All data analysis will be done in R, transparently reporting the source code used to analyze the data.
Project organization: The project is organized with a Clinical Research Group and an Analytical Research Group. The clinical group includes specialists from the medical, gastroenterological, departments that are sampling the cohort. The analytical group will perform the analyses on the biological material.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Primary exposure variable
1. Specific activated CD8+ T-cell transcriptome signature in biopsies is associated with better treatment outcome
2. Specific activated CD8+ T-cell transcriptome signature in blood is associated with better treatment outcome
Other (exploratory) exposure variables
Specific transcriptomic signatures in intestinal biopsies and peripheral blood mononuclear cells (PBMCs) of IBD patients can work as a predictive biomarker for the tumor necrosis factor inhibitors (TNFi) treatment response
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* initiation of targeted therapy
* able to read and understand Danish
Exclusion Criteria
* Not mentally able to reply the questionnaire
18 Years
ALL
No
Sponsors
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Odense University Hospital
OTHER
Hospital of Southern Jutland
OTHER
University of Kiel
OTHER
Colitis-Crohn Foreningen
OTHER
University of Southern Denmark
OTHER
Responsible Party
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Vibeke Andersen
Professor
Principal Investigators
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Vibeke Andersen, Prof
Role: PRINCIPAL_INVESTIGATOR
University of Southern Denmark
Locations
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Odense University Hospital
Odense, Denmark, Denmark
Countries
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Other Identifiers
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BELIEVE-IBD-SCT
Identifier Type: -
Identifier Source: org_study_id