Inflammatory Bowel DiseaseNCT02612103
Biomarkers in Inflammatory Bowel Diseases
An observational study of Inflammatory Bowel Disease and Colitis, Ulcerative, run by Line Elberg Godskesen at 1 site in Denmark.
Trial summary
Ulcerative colitis (UC) and Crohn's disease (CD) are chronic relapsing inflammatory bowel diseases (IBD). At the time of diagnosis it is not possible to predict the course of the disease, which can range from a few flares in a lifetime to uncontrollable disease leading to hospitalization, surgery and stoma. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Disease, Colitis, Ulcerative, Crohn Disease
- How many people
- 193 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2015to Jun 2019
- How long will I take part?
- 1 Year
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: IBD and IBS patients at The Department of Medical Gastroenterology, Odense University Hospital will be asked to participate when they contact the department due to progression in disease activity or at their regular consultations in the out-patient clinic. Healthy controls will be recruited by advertising in local news paper and advertising in public places.
Who may be able to join
- Age ≥18 years
- Written informed consent
- and one of:
- for Crohn's disease - active disease: Verified CD diagnosis according to clinical, endoscopic and histological standard criteria and Harvey Bradshaw index > 4.
- for Crohn's disease - disease in remission: Verified CD diagnosis according to clinical, endoscopic and histological standard criteria and Harvey Bradshaw index ≤ 4.
- Ulcerative colitis - active disease: Verified UC diagnosis according to clinical, endoscopic and histological standard criteria and SCCAI > 3.
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- Ulcerative colitis - in remission: Verified UC diagnosis according to clinical, endoscopic and histological standard criteria and SCCAI ≤ 3.
- Irritable bowel syndrome: Verified IBS according to standard criteria.
- Healthy control: No known chronic diseases which needs continuously medication.
Who cannot join
- Common to all participants:
- Patient with ostomy or pouch.
- The patient has had colon cancer, dysplasia or adenomatous polyps in the colon during the recent 5 year
- The patient is in a poor general condition.
- The patient is pregnant at the time of inclusion or has planned pregnancy during the period of study.
- The patient cannot understand the information material.
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- Healthy control:
- The patient has a chronic disease.
- IBS symptoms according to standard criteria.
- The patient has had any type of illness within the last 14 days (for example diarrhea, a cold etc.).
- The patient has any type of on-going medication or new medication within the last 14 days (except contraceptive pills and vitamins).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Markers of the Extracellular Matrix Turnover as Biomarkers in Inflammatory Bowel Diseases and Establishment of an Inflammatory Bowel Diseases (IBD) Biobank
Ulcerative colitis (UC) and Crohn's disease (CD) are chronic relapsing inflammatory bowel diseases (IBD). At the time of diagnosis it is not possible to predict the course of the disease, which can range from a few flares in a lifetime to uncontrollable disease leading to hospitalization, surgery and stoma. There is a continuous need to improve diagnostic and prognostic tools.
In chronic inflammation diseases there is an excessive turnover of the extracellular tissue. Tissue is broken down to small fragments and released into the circulation. Changes in the amount of these fragments in the blood may provide information on the damage and quality of the affected tissue and may therefore act as objective measure of disease burden and severity - a so called biomarker.
Read more
The potential of such biomarkers is evaluated in a combined cross-sectional and longitudinal survey including 300 patients with UC, CD, irritable bowel disease and healthy controls. The patients are followed for up to 1 year. Changes in biomarker are correlated to standard markers of inflammation during active disease and remission.
Perspective The use of new biomarkers may offer a tool to evaluate early changes in the gut of patients with IBD, may be a supplement to the diagnosis, serve as markers for effect of treatment and prognosis, and in time be a good alternative to fecal samples or endoscopy.
- Keywords
- Biochemical markers
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Active Crohns disease | Verified Crohns disease diagnosis according to clinical, endoscopic and histological standard criteria and Harvey Bradshaw index > 4. | |
| Crohns disease in remission | Verified Crohns disease diagnosis according to clinical, endoscopic and histological standard criteria and Harvey Bradshaw index ≤ 4. | |
| Active ulcerative colitis | Verified ulcerative colitis diagnosis according to clinical, endoscopic and histological standard criteria and Simple Clinical Colitis Activity Index > 3. | |
| Ulcerative colitis in remission | Verified ulcerative colitis diagnosis according to clinical, endoscopic and histological standard criteria and Simple Clinical Colitis Activity Index ≤ 3. | |
| Irritable bowel syndrome | Verified irritable bowel syndrome according to standard criteria. | |
| Healthy controls | No known chronic diseases which needs continuously medication. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum markers of extracellular matrix proteins (C1M, C3M, C4M, C5M, P1NP, VICM, P1NP, EL-NE, BGM and Pro-C5)
The biomarkers are evaluated in relation to type of disease and disease activity.
Measured: Follow-up of 1 year for patients with active IBD. For all other groups the study are cross-sectional
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionJan 2018
- Study completionJun 2019
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 193 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Line Elberg Godskesen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark
- Responsible party
- Sponsor-investigator, Line Elberg Godskesen, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02612103
- Sponsor's protocol ID
- S-20150107
- Status last verified
- Mar 2018
- First submitted
- 19 Nov 2015
- Last updated
- 25 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Markers of the Extracellular Matrix Turnover as Biomarkers in Inflammatory Bowel Diseases and Establishment of an Inflammatory Bowel Diseases (IBD) Biobank
- ClinicalTrials.gov ID
- NCT02612103
- Acronym / sponsor ID
- S-20150107
- Keywords
- Biochemical markers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Line Elberg GodskesenUniversity, hospital or other
- Collaborators
- University of Southern Denmark
- Study start
- Nov 2015
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 23 Nov 2015 (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.
Ulcerative colitis (UC) and Crohn's disease (CD) are chronic relapsing inflammatory bowel diseases (IBD). At the time of diagnosis it is not possible to predict the course of the disease, which can range from a few flares in a lifetime to uncontrollable disease leading to hospitalization, surgery and stoma. There is a continuous need to improve diagnostic and prognostic tools.
In chronic inflammation diseases there is an excessive turnover of the extracellular tissue. Tissue is broken down to small fragments and released into the circulation. Changes in the amount of these fragments in the blood may provide information on the damage and quality of the affected tissue and may therefore act as objective measure of disease burden and severity - a so called biomarker.
The potential of such biomarkers is evaluated in a combined cross-sectional and longitudinal survey including 300 patients with UC, CD, irritable bowel disease and healthy controls. The patients are followed for up to 1 year. Changes in biomarker are correlated to standard markers of inflammation during active disease and remission.
Perspective The use of new biomarkers may offer a tool to evaluate early changes in the gut of patients with IBD, may be a supplement to the diagnosis, serve as markers for effect of treatment and prognosis, and in time be a good alternative to fecal samples or endoscopy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Active Crohns disease | – | –Verified Crohns disease diagnosis according to clinical, endoscopic and histological standard criteria and Harvey Bradshaw index > 4. |
| Crohns disease in remission | – | –Verified Crohns disease diagnosis according to clinical, endoscopic and histological standard criteria and Harvey Bradshaw index ≤ 4. |
| Active ulcerative colitis | – | –Verified ulcerative colitis diagnosis according to clinical, endoscopic and histological standard criteria and Simple Clinical Colitis Activity Index > 3. |
| Ulcerative colitis in remission | – | –Verified ulcerative colitis diagnosis according to clinical, endoscopic and histological standard criteria and Simple Clinical Colitis Activity Index ≤ 3. |
| Irritable bowel syndrome | – | –Verified irritable bowel syndrome according to standard criteria. |
| Healthy controls | – | –No known chronic diseases which needs continuously medication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- IBD and IBS patients at The Department of Medical Gastroenterology, Odense University Hospital will be asked to participate when they contact the department due to progression in disease activity or at their regular consultations in the out-patient clinic. Healthy controls will be recruited by advertising in local news paper and advertising in public places.
Key inclusion criteria (9 listed)
- Age ≥18 years
- Written informed consent
- and one of:
- for Crohn's disease - active disease: Verified CD diagnosis according to clinical, endoscopic and histological standard criteria and Harvey Bradshaw index > 4.
- for Crohn's disease - disease in remission: Verified CD diagnosis according to clinical, endoscopic and histological standard criteria and Harvey Bradshaw index ≤ 4.
Key exclusion criteria (11 listed)
- Common to all participants:
- Healthy control:
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
Serum markers of extracellular matrix proteins (C1M, C3M, C4M, C5M, P1NP, VICM, P1NP, EL-NE, BGM and Pro-C5)
Time frame: Follow-up of 1 year for patients with active IBD. For all other groups the study are cross-sectional
The biomarkers are evaluated in relation to type of disease and disease activity.
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 25 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Colitis, Ulcerative, run by Line Elberg Godskesen 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 9 inclusion and 11 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 25 Oct 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?
Serum markers of extracellular matrix proteins (C1M, C3M, C4M, C5M, P1NP, VICM, P1NP, EL-NE, BGM and Pro-C5) (time frame: Follow-up of 1 year for patients with active IBD. For all other groups the study are cross-sectional). 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 25 Oct 2019.