Inflammatory Bowel DiseaseNCT01861288
Deep Endoscopic Remission Assessed by a Surrogate Biomarker in Patients With Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Disease and Crohn Disease, run by Herlev Hospital at 1 site in Denmark.
Trial summary
We hypothesize that the number of needed endoscopic procedure performed at IBD patients (adult and children), can be reduced by using an individualized algorithm of symptoms, blood and faecal biomarkers. Read more about this study
- Who is it for?
- Ages Up to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Disease, Crohn Disease, Ulcerative Colitis
- How many people
- 157 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2013to 28 Feb 2018
- 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 Up to 67 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study includes adult and pediatric patients with and without IBD who, as part of an ongoing investigation or treatment, have to undergo a sigmoidoscopy (for children: colonoscopy).
Who may be able to join
- Patients scheduled for endoscopy
- Age 0 - 67 years
- Intestinal infections ruled out by stool sample analysis for pathogenic bacteria, parasites and Clostridium difficile
- CMV ruled out
- Fluent in Danish
Who cannot join
- American Society of Anesthesiologists (ASA) score III or above
- Patients who are alcohol or drug abusers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a New Algorithm to Determine the Activity of Disease: Deep Endoscopic Remission Assessed by a Surrogate Biomarker in Patients With IBD.
We hypothesize that the number of needed endoscopic procedure performed at IBD patients (adult and children), can be reduced by using an individualized algorithm of symptoms, blood and faecal biomarkers.
The aim of the study is to reduce the numbers of endoscopies, as the procedure is uncomfortable for the patient, time consuming and expensive. Through indirect tests - blood test, fecal inflammation marker and clinical symptoms - compared to endoscopic findings, we want to construct an algorithm by which the intestinal healing can be foreseen without performing an endoscopy.
Furthermore, we will correlate FC, blood tests, clinical symptom score and endoscopic score, with the histo-pathological inflammation score from intestinal biopsies and the immunological score depicted by TNF- alpha and IL17A levels in intestinal tissue, in order to assess the gold standard - endoscopic remission.
Read the detailed description
Deep remission: The treatment goal in patiens with IBD is to achieve deep remission before drug withdrawal to avoid relapse. In order to evaluate the healing of mucosa, it is currently necessary to carry out an endoscopy, despite the additional information provided by FC and blood samples. The endoscopic procedure is uncomfortable for the patient, time consuming and expensive. We therefore seek, on the basis of existing knowledge and using a correlation between FC, blood tests and clinical remission with endoscopic findings, to establish some non-invasive biomarkers that might express deep remission. In the long run, threshold levels will be used as indicators for performing an endoscopy and, hopefully, reduce the need for it to be performed. We will compare the results from children and adults because it is likely there exist differences in their respective FC levels.
Histopathologic remission: Biopsies of the intestinal tissue can be evaluated histopathologically and indicate the level of microscopic inflammation and can assess the acute and chronic inflammatory signs at the cellular level, e.g. altered glandular structure, crypt abscess and ulcerations. By using the Karl Geboes grading system, microscopic histopathological deep remission can be assessed. We will explore the endoscopic 'gold standard' by comparing endoscopic remission with histopathological remission.
Immunological remission: In general, tissue factors are linked to various immunological pathways belonging to the innate, adaptive and regulatory immune response, comprising a pro-inflammatory and an anti-inflammatory response. This includes molecules such as cytokines, chemokines, adhesion molecules and their corresponding cellular and soluble receptors. Tumor-necrosis-factor (TNF)-alpha and interleukin 17A is two of several molecules in the pro-inflammatory process that is strongly associated with the grade of inflammation in IBD (Florholmen and Fries 2011). Olsen et al. 2009 have reported that a normalization of mucosal TNF-alpha in most ulcerative colitis patients will represent an endoscopically healed mucosa.
In addition to clinical indexes, endoscopic and histological criteria, we also introduce a molecular based Immunological Remission. A working hypothesis is that immunological remission is a state of normalization of the pro-inflammatory and anti-inflammatory processes in mucosa. The concept of immunological remission and the potential clinical impact are still in the early phases of evaluation, and to obtain a practical application a non-invasive test, such as one based on a stool sample, must be developed. In the current project, immunological remission will be a part of this study, as endoscopic and histopathology remission, with correlation to FC, blood tests and clinical remission.
- Keywords
- Inflammatory Bowel Disease, Fecal Calprotectin, Clinical IBD score (SCCAI, PUCAI, aPCDAI), Endoscopic deep remission, Histopathologic deep remission, Immunological deep remission, Treatment algorithm
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults and children with and without IBD | The study includes adult and pediatric patients with and without IBD who, as part of an ongoing investigation or treatment, have to undergo a sigmoidoscopy (for children: colonoscopy). Inclusion of adult patients, age 15-67 years: 50 patients with UC in remission, 50 patients with active UC, 50 patients without IBD Inclusion of pediatric patients, <15 years: We expect to include: 10 UC / CD patients in remission,10 UC / CD patients in relapse,10 non-IBD patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal Calprotectin (FC)and clinical score
FC is an inflammation marker from intestinal mucosa.
Clinical score by Simple Clinical Colitis Activity Index, SCCAI. SCCAI is a specific Ulcerative Colitis index.
Measured: Two FC test will be analysed up to 1 week before the endoscopy. SCCAI will be collected up to 1 week before endoscopy.
Secondary outcomes (1)
Histopathological and Immunological inflammation score
Histopathological inflammation: intestinal biopsies assessed by Karl Geboes score.
Immunological score: TNF- alpha and Interleukin 17 A levels in intestinal biopsies assessed by PCR analysis
Measured: up to 8 weeks after endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2013 (estimated)
- Study start1 Nov 2013
- Primary completion5 Sep 2016
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of North Norway, Hvidovre University Hospital
- Responsible party
- Principal investigator, Katrine Carlsen, Herlev Hospital
- Investigators
- Katrine Carlsen, MD, Principal investigator, Departmen of Gastroenterology, Herlev University HospitalPia Munkholm, Professor, Study director, Department of Gastroenterology, Herlev University HospitalVibeke Wewer, MD, Phd, Study chair, Hvidovre University HospitalLene Riis, MD, PhD, Study chair, Department of Pathology, Herlev University HospitalChristian Jakobsen, MD, PhD, Study chair, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01861288
- Sponsor's protocol ID
- DER-SBIO
- Status last verified
- Feb 2018
- First submitted
- 17 May 2013
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a New Algorithm to Determine the Activity of Disease: Deep Endoscopic Remission Assessed by a Surrogate Biomarker in Patients With IBD.
- ClinicalTrials.gov ID
- NCT01861288
- Acronym / sponsor ID
- DER-SBIO
- Keywords
- Inflammatory Bowel Disease, Fecal Calprotectin, Clinical IBD score (SCCAI, PUCAI, aPCDAI), Endoscopic deep remission, Histopathologic deep remission, Immunological deep remission, Treatment algorithm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Collaborators
- University Hospital of North Norway, Hvidovre University Hospital
- Study start
- 1 Nov 2013 (actual)
- Primary completion
- 5 Sep 2016 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 23 May 2013 (estimated)
- 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.
We hypothesize that the number of needed endoscopic procedure performed at IBD patients (adult and children), can be reduced by using an individualized algorithm of symptoms, blood and faecal biomarkers.
The aim of the study is to reduce the numbers of endoscopies, as the procedure is uncomfortable for the patient, time consuming and expensive. Through indirect tests - blood test, fecal inflammation marker and clinical symptoms - compared to endoscopic findings, we want to construct an algorithm by which the intestinal healing can be foreseen without performing an endoscopy.
Furthermore, we will correlate FC, blood tests, clinical symptom score and endoscopic score, with the histo-pathological inflammation score from intestinal biopsies and the immunological score depicted by TNF- alpha and IL17A levels in intestinal tissue, in order to assess the gold standard - endoscopic remission.
Detailed description
Deep remission: The treatment goal in patiens with IBD is to achieve deep remission before drug withdrawal to avoid relapse. In order to evaluate the healing of mucosa, it is currently necessary to carry out an endoscopy, despite the additional information provided by FC and blood samples. The endoscopic procedure is uncomfortable for the patient, time consuming and expensive. We therefore seek, on the basis of existing knowledge and using a correlation between FC, blood tests and clinical remission with endoscopic findings, to establish some non-invasive biomarkers that might express deep remission. In the long run, threshold levels will be used as indicators for performing an endoscopy and, hopefully, reduce the need for it to be performed. We will compare the results from children and adults because it is likely there exist differences in their respective FC levels.
Histopathologic remission: Biopsies of the intestinal tissue can be evaluated histopathologically and indicate the level of microscopic inflammation and can assess the acute and chronic inflammatory signs at the cellular level, e.g. altered glandular structure, crypt abscess and ulcerations. By using the Karl Geboes grading system, microscopic histopathological deep remission can be assessed. We will explore the endoscopic 'gold standard' by comparing endoscopic remission with histopathological remission.
Immunological remission: In general, tissue factors are linked to various immunological pathways belonging to the innate, adaptive and regulatory immune response, comprising a pro-inflammatory and an anti-inflammatory response. This includes molecules such as cytokines, chemokines, adhesion molecules and their corresponding cellular and soluble receptors. Tumor-necrosis-factor (TNF)-alpha and interleukin 17A is two of several molecules in the pro-inflammatory process that is strongly associated with the grade of inflammation in IBD (Florholmen and Fries 2011). Olsen et al. 2009 have reported that a normalization of mucosal TNF-alpha in most ulcerative colitis patients will represent an endoscopically healed mucosa.
In addition to clinical indexes, endoscopic and histological criteria, we also introduce a molecular based Immunological Remission. A working hypothesis is that immunological remission is a state of normalization of the pro-inflammatory and anti-inflammatory processes in mucosa. The concept of immunological remission and the potential clinical impact are still in the early phases of evaluation, and to obtain a practical application a non-invasive test, such as one based on a stool sample, must be developed. In the current project, immunological remission will be a part of this study, as endoscopic and histopathology remission, with correlation to FC, blood tests and clinical remission.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults and children with and without IBD | – | –The study includes adult and pediatric patients with and without IBD who, as part of an ongoing investigation or treatment, have to undergo a sigmoidoscopy (for children: colonoscopy). Inclusion of adult patients, age 15-67 years: 50 patients with UC in remission, 50 patients with active UC, 50 patients without IBD Inclusion of pediatric patients, <15 years: We expect to include: 10 UC / CD patients in remission,10 UC / CD patients in relapse,10 non-IBD patients. |
Who may qualify
- Ages
- Up to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study includes adult and pediatric patients with and without IBD who, as part of an ongoing investigation or treatment, have to undergo a sigmoidoscopy (for children: colonoscopy).
Key inclusion criteria (5 listed)
- Patients scheduled for endoscopy
- Age 0 - 67 years
- Intestinal infections ruled out by stool sample analysis for pathogenic bacteria, parasites and Clostridium difficile
- CMV ruled out
- Fluent in Danish
Key exclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) score III or above
- Patients who are alcohol or drug abusers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fecal Calprotectin (FC)and clinical score
Time frame: Two FC test will be analysed up to 1 week before the endoscopy. SCCAI will be collected up to 1 week before endoscopy.
FC is an inflammation marker from intestinal mucosa. Clinical score by Simple Clinical Colitis Activity Index, SCCAI. SCCAI is a specific Ulcerative Colitis index.
1 secondary outcome
Histopathological and Immunological inflammation score
Time frame: up to 8 weeks after endoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
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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.
Katrine Carlsen, MD principal investigator
Departmen of Gastroenterology, Herlev University Hospital
Pia Munkholm, Professor study director
Department of Gastroenterology, Herlev University Hospital
Vibeke Wewer, MD, Phd study chair
Hvidovre University Hospital
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 Disease and Crohn Disease, run by Herlev Hospital 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 5 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: finished, as of the sponsor's last update on 27 Feb 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Fecal Calprotectin (FC)and clinical score (time frame: Two FC test will be analysed up to 1 week before the endoscopy. SCCAI will be collected up to 1 week before endoscopy.). 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 27 Feb 2019.