Inflammatory Bowel DiseasesNCT03778918
The Comparison Between the Biomarkers in Inflammatory Bowel Disease Patients and General Control Group
An observational study of Inflammatory Bowel Diseases and Irritable Bowel Syndrome, run by Bo-In Lee at 1 site in South Korea.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 19 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases, Irritable Bowel Syndrome
- What is being tested?
- inflammatory bowel disease
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2016to 30 Dec 2020
- How long will I take part?
- 36 Months
- 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 19 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: inflammatory bowel disease (ulcerative colitis, Crohn's Dz.) irritable bowel syndrome normal control
Who may be able to join
- people who receive colonoscopy
- people who sign the consent
- having inflammatory bowel disease (ulcerative colitis, Crohn's Dz.) and irritable bowel syndrome
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Division of Gastroenterology; Seoul St. Mary's hospital
Seoul, 137-701
Bo-In Lee, MD, PhD, 82-10-8367-1055, gidoc4u@gmail.com
Bo-In Lee, MD, PhD
About this study
Official title: 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.
Read the 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.
- Being tested
- inflammatory bowel disease, IBS or Normal Control
- Keywords
- REG3 alpha, IBD, biomarker, ulcerative colitis, serum calprotectin
- Medical subject headings
- Inflammatory Bowel Diseases, Irritable Bowel Syndrome, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inflammatory bowel diseaseOther
blood based biomarkers in IBD such as REG3 alpha, serum calprotectin and hs-CRP
IBS or Normal ControlOther
blood based biomarker compared normal control with IBD
| Study group | Role | What they receive |
|---|---|---|
| inflammatory bowel disease | inflammatory bowel disease such as Ulcerative colitis and Crohn's disease Receives: Other: inflammatory bowel disease; Other: IBS or Normal Control | |
| IBS or Normal Control | irritable bowel syndrome patients normal patients Receives: Other: inflammatory bowel disease; Other: IBS or Normal Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of blood-based biomarkers to predict disease activity 1
REG3 alpha (ng/mL)
Measured: within 12 weeks of the blood sampling
measurement of blood-based biomarkers to predict disease activity 2
hs-CRP (mg/dL)
Measured: within 12 weeks of the blood sampling
measurement of blood-based biomarkers to predict disease activity 3
serum calprotectin (ng/mL)
Measured: within 12 weeks of the blood sampling
Secondary outcomes (4)
Age (years)
age at the time of study enrolled
Measured: at the time of study enrolled
Gender (M/F)
male of female
Measured: at the time of study enrolled
disease duration (months)
duration of disease
Measured: at the time of study enrolled
disease onset (years)
age at which the disease begins
Measured: at the time of study enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start1 Aug 2016
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies 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
- 200 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Bo-In Lee
- Sponsor type
- University, hospital or other
- Collaborators
- Incheon St.Mary's Hospital, St Vincent's Hospital, Daejeon St. Mary's hospital
- Responsible party
- Sponsor-investigator, Bo-In Lee, Seoul St. Mary's Hospital
- Investigators
- Bo-In Lee, MD. Ph.D., Principal investigator, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03778918
- Sponsor's protocol ID
- XC18TEDI0027
- Status last verified
- Mar 2020
- First submitted
- 9 Dec 2018
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29133078Greuter 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.
PubMed 26278889Harris 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.
PubMed 23200544
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison Between That Expression Pattern and Disease Activity of Variable Biomarkers in Inflammatory Bowel Disease Patients and General Control Group. Multicenter, Prospective Study
- ClinicalTrials.gov ID
- NCT03778918
- Acronym / sponsor ID
- XC18TEDI0027
- Keywords
- REG3 alpha, IBD, biomarker, ulcerative colitis, serum calprotectin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Bo-In LeeUniversity, hospital or other
- Collaborators
- Incheon St.Mary's Hospital, St Vincent's Hospital, Daejeon St. Mary's hospital
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 19 Dec 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 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inflammatory bowel disease | – | Other: inflammatory bowel disease, Other: IBS or Normal Controlinflammatory bowel disease such as Ulcerative colitis and Crohn's disease |
| IBS or Normal Control | – | Other: inflammatory bowel disease, Other: IBS or Normal Controlirritable bowel syndrome patients normal patients |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- inflammatory bowel disease (ulcerative colitis, Crohn's Dz.) irritable bowel syndrome normal control
Key inclusion criteria (3 listed)
- people who receive colonoscopy
- people who sign the consent
- having inflammatory bowel disease (ulcerative colitis, Crohn's Dz.) and irritable bowel syndrome
Key exclusion criteria (6 listed)
- 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)
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 |
|---|---|---|
| inflammatory bowel diseaseblood based biomarkers in IBD such as REG3 alpha, serum calprotectin and hs-CRP | Other | IBS or Normal Control, inflammatory bowel disease |
| IBS or Normal Controlblood based biomarker compared normal control with IBD | Other | IBS or Normal Control, inflammatory bowel disease |
Primary outcome
measurement of blood-based biomarkers to predict disease activity 1
Time frame: within 12 weeks of the blood sampling
REG3 alpha (ng/mL)
measurement of blood-based biomarkers to predict disease activity 2
Time frame: within 12 weeks of the blood sampling
hs-CRP (mg/dL)
measurement of blood-based biomarkers to predict disease activity 3
Time frame: within 12 weeks of the blood sampling
serum calprotectin (ng/mL)
4 secondary outcomes
Age (years)
Time frame: at the time of study enrolled
Gender (M/F)
Time frame: at the time of study enrolled
disease duration (months)
Time frame: at the time of study enrolled
disease onset (years)
Time frame: at the time of study enrolled
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Background: PubMed 29133078Darnaud 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.
- Background: PubMed 26278889Greuter 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.
- Background: PubMed 23200544Harris 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.
- 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.
Bo-In Lee, MD. Ph.D. principal investigator
Seoul St. Mary's 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 Diseases and Irritable Bowel Syndrome, run by Bo-In Lee at 1 site in South Korea.
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 3 inclusion and 6 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 3 Mar 2020. 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 South Korea. 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 Bo-In Lee, MD. Ph.D. (82-10-8367-1055, gidoc4u@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement of blood-based biomarkers to predict disease activity 1 (time frame: within 12 weeks of the blood sampling). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03778918, which also lists 3 linked publications.
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 3 Mar 2020.