Usefulness of Calprotectin for Colon Adenoma Screening | NCT01719198

Studies
Usefulness of Calprotectin for Colon Adenoma Screening

NCT01719198

Sponsor

Konkuk University Medical Center

Status

Unknown status

Last Update Posted

Nov 14, 2012Estimated

Enrollment

500Estimated

Phase

Not provided

Conditions

Colon Adenoma

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Mar 2013Estimated

Completion Date

Not provided

First Submitted Date

Oct 30, 2012

First Submission Date that Met QC Criteria

Oct 31, 2012

First Posted Date

Nov 1, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 12, 2012

Last Update Posted Date

Nov 14, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chul Min Park, MD, clinical instructor, Konkuk University Medical CenterPrincipal Investigator

Lead Sponsor

Konkuk University Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

500Estimated

Measure	Description	Time Frame
fecal calprotectin level		1 day (at the hospital visit)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

over 18 years old adult population

Exclusion Criteria:

none

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yeo-Min Yun, MD, PhD	Konkuk University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Konkuk University Medical Center	Recruiting	Seoul		147-729	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D000236	Adenoma

Ancestor Terms

ID	Term
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

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Browse Branches

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