NCT01719198

Brief 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. We will investigate the usefulness of fecal calprotectin as colon adenoma marker for screening in this study.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Last Updated

November 14, 2012

Status Verified

November 1, 2012

Enrollment Period

5 months

First QC Date

October 30, 2012

Last Update Submit

November 12, 2012

Conditions

Colon Adenoma

Keywords

adenomacalprotectin

Outcome Measures

Primary Outcomes (1)

  • fecal calprotectin level

    1 day (at the hospital visit)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients who visit KUH healthcare center for colonoscopy in Korea over 18 years old adult population

You may qualify if:

  • over 18 years old adult population

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konkuk University Medical Center

Seoul, 147-729, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

stool specimen

MeSH Terms

Conditions

Adenoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Yeo-Min Yun, MD, PhD

    Konkuk University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical instructor

Study Record Dates

First Submitted

October 30, 2012

First Posted

November 1, 2012

Study Start

October 1, 2012

Primary Completion

March 1, 2013

Last Updated

November 14, 2012

Record last verified: 2012-11

Locations

KR(1)