Inflammatory Bowel DiseasesNCT05350644
Inflammatory Bowel Disease(IBD), Treatment Response
An observational study of Inflammatory Bowel Diseases and Ulcerative Colitis, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
Inflammatory bowel diseases (IBD) is treated with biologics targeting the pro-inflammatory molecule tumour necrosis factor-α (TNF), i.e. TNF inhibitors. Up to one third of the patients do, however, not respond to biologics and little is known of the biological mechanism as a prognostic factor (possibly enabling… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease
- What is being tested?
- Primary exposure variable and Other (exploratory) exposure variables
- How many people
- 2 participants
- Where
- 1 siteDenmark
- Study dates
- 8 Feb 2022to 30 Jun 2024
- 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: targeted therapy and able to read and understand Danish.
Who may be able to join
- diagnosed with inflammatory bowel disease
- initiation of targeted therapy
- able to read and understand Danish
Who cannot join
- Patients with cancer
- Not mentally able to reply the questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predicting Response to Medical Treatment of Inflammatory Bowel Disease (IBD) Using Single Cell Transcriptomic on Intestinal Biopsies: a Prospective Cohort Study of Personalized Medicine
Inflammatory bowel diseases (IBD) is treated with biologics targeting the pro-inflammatory molecule tumour necrosis factor-α (TNF), i.e. TNF inhibitors. Up to one third of the patients do, however, not respond to biologics and little is known of the biological mechanism as a prognostic factor (possibly enabling personalised medicine). The aim of this project is to identify biomarkers that support individualized forecasting of optimized treatment outcome on these costly drugs.
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.
Read more
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.
Read the detailed description
Inflammatory bowel diseases [IBD] (of which Crohn's disease (CD) and ulcerative colitis (UC) are the two most prevailed entities) is a disease of the immune system that are managed with biological agents targeting the pro-inflammatory cytokine tumour necrosis factor-α (TNF), i.e. TNF inhibitors.
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.
- Being tested
- Primary exposure variable, Other (exploratory) exposure variables
- Keywords
- Biomarkers, Treatment outcome, Transcriptomics
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary exposure variableOther
Also called Transcriptome signature
- Specific activated CD8+ T-cell transcriptome signature in biopsies is associated with better treatment outcome
- Specific activated CD8+ T-cell transcriptome signature in blood is associated with better treatment outcome
Other (exploratory) exposure variablesOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Clinical response to therapy depending on condition
The predefined primary endpoint will be the proportion of patients with clinical response to therapy at first clinical follow-up.
- Crohn's disease: Harvey Bradshaw Index (HBI) 4 or less (clinical remission) to <16 (non-remission)
- Ulcerative colitis: Mayo Clinic Score of 2 or less (with no individual subscore of >1) (remission) to <12 (non-remission)
Measured: week 14-16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start8 Feb 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2024
Why it stopped: Recruitment of patients for this clinical trial has been withdrawn due to logistical challenges and the inability to enroll a sufficient number of participants meeting the specific eligibility criteria within the projected timeline.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Hospital of Southern Jutland, University of Kiel, Colitis-Crohn Foreningen
- Responsible party
- Principal investigator, Vibeke Andersen, University of Southern Denmark
- Investigators
- Vibeke Andersen, Prof, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05350644
- Sponsor's protocol ID
- BELIEVE-IBD-SCT
- Status last verified
- May 2022
- First submitted
- 22 Apr 2022
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Response to Medical Treatment of Inflammatory Bowel Disease (IBD) Using Single Cell Transcriptomic on Intestinal Biopsies: a Prospective Cohort Study of Personalized Medicine
- ClinicalTrials.gov ID
- NCT05350644
- Acronym / sponsor ID
- BELIEVE-IBD-SCT
- Keywords
- Biomarkers, Treatment outcome, Transcriptomics
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruitment of patients for this clinical trial has been withdrawn due to logistical challenges and the inability to enroll a sufficient number of participants meeting the specific eligibility criteria within the projected timeline.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Odense University Hospital, Hospital of Southern Jutland, University of Kiel, Colitis-Crohn Foreningen
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 28 Apr 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.
Inflammatory bowel diseases (IBD) is treated with biologics targeting the pro-inflammatory molecule tumour necrosis factor-α (TNF), i.e. TNF inhibitors. Up to one third of the patients do, however, not respond to biologics and little is known of the biological mechanism as a prognostic factor (possibly enabling personalised medicine). The aim of this project is to identify biomarkers that support individualized forecasting of optimized treatment outcome on these costly drugs.
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
Inflammatory bowel diseases [IBD] (of which Crohn's disease (CD) and ulcerative colitis (UC) are the two most prevailed entities) is a disease of the immune system that are managed with biological agents targeting the pro-inflammatory cytokine tumour necrosis factor-α (TNF), i.e. TNF inhibitors.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- targeted therapy and able to read and understand Danish.
Key inclusion criteria (3 listed)
- diagnosed with inflammatory bowel disease
- initiation of targeted therapy
- able to read and understand Danish
Key exclusion criteria (2 listed)
- Patients with cancer
- Not mentally able to reply the questionnaire
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 |
|---|---|---|
| Primary exposure variableAlso: Transcriptome signature1. 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 | – |
| Other (exploratory) exposure variablesSpecific 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 | – |
Primary outcome
1. Clinical response to therapy depending on condition
Time frame: week 14-16
The predefined primary endpoint will be the proportion of patients with clinical response to therapy at first clinical follow-up. * Crohn's disease: Harvey Bradshaw Index (HBI) 4 or less (clinical remission) to <16 (non-remission) * Ulcerative colitis: Mayo Clinic Score of 2 or less (with no individual subscore of >1) (remission) to <12 (non-remission)
Results and safety
The study was stopped early (reason given: Recruitment of patients for this clinical trial has been withdrawn due to logistical challenges and the inability to enroll a sufficient number of participants meeting the specific eligibility criteria within the projected timeline.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Inflammatory Bowel Diseases
Active, not recruitingObservational study
A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis
Colitis, Ulcerative
RecruitingObservational study
Effects Of Periodontal Therapy In Patients With Inflammatory Bowel Disease
Periodontal Diseases, IBD
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool
Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Inflammatory Bowel Syndrome
RecruitingPhase 1/2
Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis
Ulcerative Colitis (UC)
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.
Vibeke Andersen, Prof principal investigator
University of Southern Denmark
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 Inflammatory Bowel Diseases and Ulcerative Colitis, run by University of Southern Denmark at 1 site in Denmark.
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 2 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: stopped early, as of the sponsor's last update on 10 Dec 2024. 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 Denmark. 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?
The study was stopped early (reason given: Recruitment of patients for this clinical trial has been withdrawn due to logistical challenges and the inability to enroll a sufficient number of participants meeting the specific eligibility criteria within the projected timeline.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Clinical response to therapy depending on condition (time frame: week 14-16). 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 10 Dec 2024.