Colon AdenomaNCT01719198
Usefulness of Calprotectin for Colon Adenoma Screening
An observational study of Colon Adenoma, run by Konkuk University Medical Center at 1 site in South Korea.
Trial summary
The fecal calprotectin assay is used widely for inflammatory bowel disease diagnosis and the assessment of the disease activity. Some adenoma patients have elevated fecal calprotectin level, which could mean the role of fecal calprotectin as a screening marker for colon adenoma. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colon Adenoma
- How many people
- 500 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2012to Mar 2013
- 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: patients who visit KUH healthcare center for colonoscopy in Korea over 18 years old adult population
Who may be able to join
- over 18 years old adult population
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Konkuk University Medical Center
Seoul, 147-729
Chul Min Park, MD, i004@snu.ac.kr
Chul Min Park, MD
About this study
Official title: Usefulness of Fecal Calprotectin for Screening Colon Adenoma in Korean Population
The fecal calprotectin assay is used widely for inflammatory bowel disease diagnosis and the assessment of the disease activity. Some adenoma patients have elevated fecal calprotectin level, which could mean the role of fecal calprotectin as a screening marker for colon adenoma. We will investigate the usefulness of fecal calprotectin as colon adenoma marker for screening in this study.
- Conditions
- Colon Adenoma
- Keywords
- adenoma, calprotectin
- Medical subject headings
- Adenoma
What is being measured
The primary outcome is the main question the study is designed to answer.
fecal calprotectin level
Measured: 1 day (at the hospital visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon AdenomaStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chul Min Park, MD, Konkuk University Medical Center
- Investigators
- Yeo-Min Yun, MD, PhD, Principal investigator, Konkuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01719198
- Sponsor's protocol ID
- KUH1220
- Status last verified
- Nov 2012
- First submitted
- 30 Oct 2012
- Last updated
- 14 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Fecal Calprotectin for Screening Colon Adenoma in Korean Population
- ClinicalTrials.gov ID
- NCT01719198
- Acronym / sponsor ID
- KUH1220
- Conditions
- Colon Adenoma
- Keywords
- adenoma, calprotectin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Mar 2013 (estimated)
- First posted
- 1 Nov 2012 (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.
The fecal calprotectin assay is used widely for inflammatory bowel disease diagnosis and the assessment of the disease activity. Some adenoma patients have elevated fecal calprotectin level, which could mean the role of fecal calprotectin as a screening marker for colon adenoma. We will investigate the usefulness of fecal calprotectin as colon adenoma marker for screening in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients who visit KUH healthcare center for colonoscopy in Korea over 18 years old adult population
Key inclusion criteria (1 listed)
- over 18 years old adult population
Key exclusion criteria (1 listed)
- none
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
fecal calprotectin level
Time frame: 1 day (at the hospital visit)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2012.
Related trials for Colon Adenoma
RecruitingPhase 1
Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma
Mesothelioma, Neoplasms
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingObservational study
KLF4 Epigenetic Modulation
KLF4 Methylation, Epigenetic
RecruitingPhase 1/2
Lead-212 PSV359 Therapy for Patients With Solid Tumors
Pancreatic Ductal Adenocarcinoma, Gastric Cancer
RecruitingObservational study
Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
Solid Tumor, Adult, Colorectal Cancer
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.
Yeo-Min Yun, MD, PhD principal investigator
Konkuk University
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 Colon Adenoma, run by Konkuk University Medical Center 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 1 inclusion and 1 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 14 Nov 2012. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fecal calprotectin level (time frame: 1 day (at the hospital visit)). 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 14 Nov 2012.