Specific microRNAs as Potential Biomarker for Inflammatory Bowel Disease
Blood Level of Specific microRNA Pattern as Potential Biomarker for Inflammatory Bowel Disease
1 other identifier
interventional
350
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
October 4, 2018
CompletedFirst Posted
Study publicly available on registry
October 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedOctober 9, 2018
August 1, 2018
3.9 years
October 4, 2018
October 4, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Correlation between microRNA expression level in peripheral blood (qPCR) and disease activity of intestinal Inflammation of CD and UC
1 day
Secondary Outcomes (1)
Assessment of the potential of specific miRNAs to discriminate CD and UC in peripheral blood (qPCR)
1 day
Study Arms (1)
Patients with intestinal colitis and control patients
OTHERDevice: qPCR diagnostic of specific microRNAs in peripheral blood (10 ml)
Interventions
10 ml of blood will be removed from a peripheral vene during routine diagnostical blood draw
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Age under 18 years
- Pregnancy
- Inability to understand information for participation
- Refusal of participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Muenster
Münster, North Rhine-Westphalia, 48149, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anna Friederike Cordes, MD, PhD
University Hospital Muenster, University of Muenster
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2018
First Posted
October 9, 2018
Study Start
January 1, 2017
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
October 9, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share