NCT01428752

Brief Summary

Current guidelines for initiating screening colonoscopies in patients younger than 50 years of age who have a first relative history of colorectal cancer are controversial. The aim of this study was to prospectively define the prevalence of colorectal adenoma 30- to 49-years-old asymptomatic subjects with a first relative history of colorectal cancer and to compare the data with controls. Design: Single-center prospective study

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2011

Typical duration 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

September 1, 2011

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 2, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 5, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

September 9, 2011

Status Verified

September 1, 2011

Enrollment Period

3 years

First QC Date

September 2, 2011

Last Update Submit

September 8, 2011

Conditions

Keywords

colonoscopycolorectal neoplasmsscreeningfamily history

Outcome Measures

Primary Outcomes (1)

  • prevalence of colorectal adenoma(any size)

    First screening colonoscopy

Secondary Outcomes (1)

  • prevalence of advanced adenoma

    First screening colonoscopy

Study Arms (1)

Family history

30- to 49-year-old asymptomatic subjects with a first relative history of colorectal cancer

Eligibility Criteria

Age30 Years - 49 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

30- to 49-year-old asymptomatic subjects undergoing first screening colonoscopy because of a first relative history of colorectal cancer

You may qualify if:

  • to 49-year-old asymptomatic subjects
  • First relative history of colorectal cancer

You may not qualify if:

  • previous colonoscopy for any reason
  • personal history of colorectal adenomas or CRC
  • history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, or inflammatory bowel disease
  • documented history of occult GI bleeding, lower gastrointestinal tract bleeding not attributable to hemorrhoid, or
  • iron deficiency anemia
  • unexplained weight loss of \>10% of the body weight in the 6 months before colonoscopy
  • incomplete examination of entire colon

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood and serum Colorectal polyp/cancer tissue

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Kyung-Jo Kim, M.D

    Department of Gastroenterology, Asan Medical Center

    STUDY DIRECTOR

Central Study Contacts

JAEIL KIM, M.D

CONTACT

KYUNG-JO KIM, M.D

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

September 2, 2011

First Posted

September 5, 2011

Study Start

September 1, 2011

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

September 9, 2011

Record last verified: 2011-09

Locations