Crohn's DiseaseNCT03698500
Specific microRNAs as Potential Biomarker for Inflammatory Bowel Disease
A study testing Removal of blood in people with Crohn's Disease and Ulcerative Colitis, run by University Hospital Muenster at 1 site in Germany.
Trial summary
The aim of this study is to assess the ability of miR-320a and other specific microRNAs to follow the disease course in patients with Crohn's disease (CD) and ulcerative colitis (UC), and to distinguish both entities, infectious colitis and healthy controls. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease, Ulcerative Colitis
- What is being tested?
- Removal of blood
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2017to Dec 2020
- Phase
- Interventional
- 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
Who may be able to join
- Patients with Crohn's disease or ulcerative colitis
- Control patients: healthy patients or patients with colitis of other origin than Crohn's disease or ulcerative colitis as well as patients with IBS
Who cannot join
- Age under 18 years
- Pregnancy
- Inability to understand information for participation
- Refusal of participation
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Muenster
Münster, North Rhine-Westphalia, 48149
Anna Friederike Cordes, MD, PhD, +49-251-83-47661, annafriederike.cordes@ukmuenster.de
Anna Friederike Cordes, MD, PhD
About this study
Official title: Blood Level of Specific microRNA Pattern as Potential Biomarker for Inflammatory Bowel Disease
The aim of this study is to assess the ability of miR-320a and other specific microRNAs to follow the disease course in patients with Crohn's disease (CD) and ulcerative colitis (UC), and to distinguish both entities, infectious colitis and healthy controls. Furthermore, the accuracy of miRNA-320a to distinguish CD or UC from irritable bowel syndrome (IBS) should be evaluated .
The study is designed as a single center non-randomised prospective trial.
Read the detailed description
Inflammatory bowel disease (IBD), which comprises Crohn's disease (CD) and ulcerative colitis (UC), is a chronic-remittent disease of the gastrointestinal tract with leading symptoms such as diarrhea, abdominal pain and rectal bleeding. Absence of mucosal inflammation (so called mucosal healing) is a promising treatment target.as it leads to reduction of colectomy rates, hospitalization and need for surgery. However, overtreatment with severe combined immunosuppressive therapy always bears the risk of severe side-effects such as opportunistic infections. To assess the course of disease, clinical evaluation, noninvasive diagnostic or imaging and invasive endoscopic techniques are currently used. As frequent endoscopical monitoring is not always possible, more specific and noninvasive biomarker are needed to monitor disease activity. The commonly used noninvasive biomarkers C-reactive protein and fecal Calprotectin, which are useful to detect disease activity, are limited due to the lacking specificity for IBD and the weak correlation with the extend of disease. Overall the currently available tools to noninvasively follow the course of disease activity do not possess appropriate specificity, sensitivity and cost effectiveness for in- and outpatient clinical monitoring.
Recently, we could demonstrate the potential of miR(microRNA)-320a to monitor disease activity in experimental colitis mouse models.
The aim of this study is to assess the ability of miR-320a and other specific microRNAs to follow the disease course in patients with inflammatory bowel disease as compared to healthy controls, non IBD-colitis and IBS.
The study is planned as a prospective single center study.
Number of patients: 7 groups of 50 patients
- 1: adult CD patients in remission
- 2: adult CD patient with endoscopical proven disease activity
- 3: adult UC patients in remission
- 4: adult UC patient with endoscopical proven disease activity
- 5: adults with infectious colitis (ie. Ischemic, infectious or toxic colitis)
- 6. Adults with IBS
- 7: healthy adults
All eligible individuals are informed about the nature of the study. All individuals provide written informed consent before entering the trial.
Budget:
All procedures in the present study are performed in ordinary patients, with ordinary staff. Therefore, no extra costs occur for personal.
- Conditions
- Crohn's Disease, Ulcerative Colitis
- Being tested
- Removal of blood
- Keywords
- Ulcerative Colitis, Crohn's disease, miRNA
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Removal of bloodOther
10 ml of blood will be removed from a peripheral vene during routine diagnostical blood draw
| Study group | Role | What they receive |
|---|---|---|
| Patients with intestinal colitis and control patients | Other | Device: qPCR diagnostic of specific microRNAs in peripheral blood (10 ml) Receives: Other: Removal of blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between microRNA expression level in peripheral blood (qPCR) and disease activity of intestinal Inflammation of CD and UC
Measured: 1 day
Secondary outcomes (1)
Assessment of the potential of specific miRNAs to discriminate CD and UC in peripheral blood (qPCR)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study startJan 2017
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Friederike Cordes, MD, PhD, Principal investigator, University Hospital Muenster, University of Muenster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03698500
- Sponsor's protocol ID
- FC201603
- Status last verified
- Aug 2018
- First submitted
- 4 Oct 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Level of Specific microRNA Pattern as Potential Biomarker for Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT03698500
- Acronym / sponsor ID
- FC201603
- Conditions
- Crohn's Disease, Ulcerative Colitis
- Keywords
- Ulcerative Colitis, Crohn's disease, miRNA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 9 Oct 2018 (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 aim of this study is to assess the ability of miR-320a and other specific microRNAs to follow the disease course in patients with Crohn's disease (CD) and ulcerative colitis (UC), and to distinguish both entities, infectious colitis and healthy controls. Furthermore, the accuracy of miRNA-320a to distinguish CD or UC from irritable bowel syndrome (IBS) should be evaluated .
The study is designed as a single center non-randomised prospective trial.
Detailed description
Inflammatory bowel disease (IBD), which comprises Crohn's disease (CD) and ulcerative colitis (UC), is a chronic-remittent disease of the gastrointestinal tract with leading symptoms such as diarrhea, abdominal pain and rectal bleeding. Absence of mucosal inflammation (so called mucosal healing) is a promising treatment target.as it leads to reduction of colectomy rates, hospitalization and need for surgery. However, overtreatment with severe combined immunosuppressive therapy always bears the risk of severe side-effects such as opportunistic infections. To assess the course of disease, clinical evaluation, noninvasive diagnostic or imaging and invasive endoscopic techniques are currently used. As frequent endoscopical monitoring is not always possible, more specific and noninvasive biomarker are needed to monitor disease activity. The commonly used noninvasive biomarkers C-reactive protein and fecal Calprotectin, which are useful to detect disease activity, are limited due to the lacking specificity for IBD and the weak correlation with the extend of disease. Overall the currently available tools to noninvasively follow the course of disease activity do not possess appropriate specificity, sensitivity and cost effectiveness for in- and outpatient clinical monitoring.
Recently, we could demonstrate the potential of miR(microRNA)-320a to monitor disease activity in experimental colitis mouse models.
The aim of this study is to assess the ability of miR-320a and other specific microRNAs to follow the disease course in patients with inflammatory bowel disease as compared to healthy controls, non IBD-colitis and IBS.
The study is planned as a prospective single center study.
Number of patients: 7 groups of 50 patients
- 1: adult CD patients in remission
- 2: adult CD patient with endoscopical proven disease activity
- 3: adult UC patients in remission
- 4: adult UC patient with endoscopical proven disease activity
- 5: adults with infectious colitis (ie. Ischemic, infectious or toxic colitis)
- 6. Adults with IBS
- 7: healthy adults
All eligible individuals are informed about the nature of the study. All individuals provide written informed consent before entering the trial.
Budget:
All procedures in the present study are performed in ordinary patients, with ordinary staff. Therefore, no extra costs occur for personal.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with intestinal colitis and control patients | Other | Other: Removal of bloodDevice: qPCR diagnostic of specific microRNAs in peripheral blood (10 ml) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with Crohn's disease or ulcerative colitis
- Control patients: healthy patients or patients with colitis of other origin than Crohn's disease or ulcerative colitis as well as patients with IBS
Key exclusion criteria (4 listed)
- Age under 18 years
- Pregnancy
- Inability to understand information for participation
- Refusal of participation
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 |
|---|---|---|
| Removal of blood10 ml of blood will be removed from a peripheral vene during routine diagnostical blood draw | Other | Patients with intestinal colitis and control patients |
Primary outcome
Correlation between microRNA expression level in peripheral blood (qPCR) and disease activity of intestinal Inflammation of CD and UC
Time frame: 1 day
1 secondary outcome
Assessment of the potential of specific miRNAs to discriminate CD and UC in peripheral blood (qPCR)
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Individual participant dataSharing planned: No
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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.
Anna Friederike Cordes, MD, PhD principal investigator
University Hospital Muenster, University of Muenster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Removal of blood in people with Crohn's Disease and Ulcerative Colitis, run by University Hospital Muenster at 1 site in Germany.
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 2 inclusion and 4 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 9 Oct 2018. 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 Germany. 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 Anna Friederike Cordes, MD, PhD (0049-(0)251-83-47661, annafriederike.cordes@ukmuenster.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between microRNA expression level in peripheral blood (qPCR) and disease activity of intestinal Inflammation of CD and UC (time frame: 1 day). 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 9 Oct 2018.