The Comparison Between the Biomarkers in Inflammatory Bowel Disease Patients and General Control Group
March 2, 2020 updated by: Bo-In Lee
The Comparison Between That Expression Pattern and Disease Activity of Variable Biomarkers in Inflammatory Bowel Disease Patients and General Control Group. Multicenter, Prospective Study
The aims of this study is to investigate a blood-based biomarker that can replace endoscopy in patients with inflammatory bowel disease.
For this purpose, blood sample of patients wiht inflammatory bowel disease (ulcerative colitis, Crohn 's disease) was collected at the same time the endoscopy is performed, stored after centrifugation, and analyzed accordingly.
Selected biomarkers from the blood sample were investigated to compare those of patients with inflammatory bowel disease and those of general controls.
Males and females over the age of 19 participated in the study and are excluded if they have chronic kidney disease or blood clotting disease.
The outcome is a find of a blood-based biomarker that best reflects a disease activity.
Study Overview
Status
Unknown
Intervention / Treatment
Detailed Description
Inflammatory bowel disease refers to chronic inflammation of the unknown origin that occurs in the intestine.
It usually refers to ulcerative colitis and Crohn's disease, which are idiopathic inflammatory bowel diseases.
While it had been known to be a common disease in the western world, in recent decades the incidence of ulcerative colitis and Crohn's disease has rapidly increased in Korea as well.
Endoscopic examination is a gold standard in order to determine the activity of inflammatory bowel disease, but it is hardly performed due to the cost and time of a test.
Therefore, it is necessary to find a blood-based biomarker that replaces endoscopy.
The objective of the study is to identify a new inflammatory marker that replaces endoscopy by comparing blood samples of patients with inflammatory bowel disease with those of general controls.
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 137-701
- Recruiting
- Division of Gastroenterology; Seoul St. Mary's hospital
-
Contact:
- Bo-In Lee, MD, PhD
- Phone Number: 82-10-8367-1055
- Email: gidoc4u@gmail.com
-
Principal Investigator:
- Bo-In Lee, MD, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
inflammatory bowel disease (ulcerative colitis, Crohn's Dz.) irritable bowel syndrome normal control
Description
Inclusion Criteria:
- people who receive colonoscopy
- people who sign the consent
- having inflammatory bowel disease (ulcerative colitis, Crohn's Dz.) and irritable bowel syndrome
Exclusion Criteria:
- those aged over 75 years
- the disabled
- pregnant women
- chronic renal diseases (CLcr <50ml/min)
- blood coagulopathy (PT INR > 1.5, aPTT > 45 seconds, or platelet count < 50,000/mm)
- people who refuse to sign the consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
inflammatory bowel disease
inflammatory bowel disease such as Ulcerative colitis and Crohn's disease
|
blood based biomarkers in IBD such as REG3 alpha, serum calprotectin and hs-CRP
blood based biomarker compared normal control with IBD
|
|
IBS or Normal Control
irritable bowel syndrome patients normal patients
|
blood based biomarkers in IBD such as REG3 alpha, serum calprotectin and hs-CRP
blood based biomarker compared normal control with IBD
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
measurement of blood-based biomarkers to predict disease activity 1
Time Frame: within 12 weeks of the blood sampling
|
REG3 alpha (ng/mL)
|
within 12 weeks of the blood sampling
|
|
measurement of blood-based biomarkers to predict disease activity 2
Time Frame: within 12 weeks of the blood sampling
|
hs-CRP (mg/dL)
|
within 12 weeks of the blood sampling
|
|
measurement of blood-based biomarkers to predict disease activity 3
Time Frame: within 12 weeks of the blood sampling
|
serum calprotectin (ng/mL)
|
within 12 weeks of the blood sampling
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Age (years)
Time Frame: at the time of study enrolled
|
age at the time of study enrolled
|
at the time of study enrolled
|
|
Gender (M/F)
Time Frame: at the time of study enrolled
|
male of female
|
at the time of study enrolled
|
|
disease duration (months)
Time Frame: at the time of study enrolled
|
duration of disease
|
at the time of study enrolled
|
|
disease onset (years)
Time Frame: at the time of study enrolled
|
age at which the disease begins
|
at the time of study enrolled
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bo-In Lee, MD. Ph.D., Seoul St. Mary's Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Darnaud M, Dos Santos A, Gonzalez P, Augui S, Lacoste C, Desterke C, De Hertogh G, Valentino E, Braun E, Zheng J, Boisgard R, Neut C, Dubuquoy L, Chiappini F, Samuel D, Lepage P, Guerrieri F, Dore J, Brechot C, Moniaux N, Faivre J. Enteric Delivery of Regenerating Family Member 3 alpha Alters the Intestinal Microbiota and Controls Inflammation in Mice With Colitis. Gastroenterology. 2018 Mar;154(4):1009-1023.e14. doi: 10.1053/j.gastro.2017.11.003. Epub 2017 Nov 11.
- Greuter T, Lang S, Holler E, Hawkey CJ, Rogler G, Biedermann L; ASTIC trial group. Serum REG3alpha and C-Reactive Protein Levels in Crohn's Disease Patients Undergoing Immunoablation and Autologous Hemopoetic Stem Cell Transplantation in the ASTIC Trial. Digestion. 2015;92(2):83-9. doi: 10.1159/000437300. Epub 2015 Aug 1.
- Harris AC, Levine JE, Ferrara JL. Have we made progress in the treatment of GVHD? Best Pract Res Clin Haematol. 2012 Dec;25(4):473-8. doi: 10.1016/j.beha.2012.10.010. Epub 2012 Oct 25.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2016
Primary Completion (Anticipated)
June 30, 2020
Study Completion (Anticipated)
December 30, 2020
Study Registration Dates
First Submitted
December 9, 2018
First Submitted That Met QC Criteria
December 16, 2018
First Posted (Actual)
December 19, 2018
Study Record Updates
Last Update Posted (Actual)
March 3, 2020
Last Update Submitted That Met QC Criteria
March 2, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XC18TEDI0027
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.