Study of Prevalence of Colorectal Adenoma in 30- to 49-year-old Subjects With a Family History of Colorectal Cancer

September 8, 2011 updated by: Jaeil Kim, Asan Medical Center

Prevalence of Colorectal Adenoma in 30- to 49-year-old Asymptomatic Subjects With a First Relative History of Colorectal Cancer

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

Study Overview

Status

Unknown

Conditions

Detailed Description

Colorectal cancer screening is recommended for average-risk persons beginning at age 50. A family history of colorectal cancer is recognized as a risk factor for colorectal adenoma. However, the strength of this association is uncertain. Current guidelines for initiating screening colonoscopies in patients younger than 50 years of age who have a first relative history of colorectal cancer have proved controversial. The conflicting recommendations are partly attributable to the lack of data about the prevalence of CRC and adenomas among 30- to 49-year-old individuals with a first relative history of colorectal cancer. This prospective study will quantify the prevalence of adenomas (any size) and advanced adenomas among 30- to 49-year-old individuals undergoing their first screening colonoscopy because of a first relative history of colorectal cancer and compare the data with controls(asymptomatic subjects without a first relative history of colorectal cancer).

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
prevalence of colorectal adenoma(any size)
Time Frame: First screening colonoscopy
First screening colonoscopy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prevalence of advanced adenoma
Time Frame: First screening colonoscopy
  1. Any adenoma ≥10 mm
  2. Any villous component
  3. High-grade dysplasia
First screening colonoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Investigators

  • Study Director: Kyung-Jo Kim, M.D, Department of Gastroenterology, Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Anticipated)

September 1, 2014

Study Completion (Anticipated)

September 1, 2014

Study Registration Dates

First Submitted

September 2, 2011

First Submitted That Met QC Criteria

September 2, 2011

First Posted (Estimate)

September 5, 2011

Study Record Updates

Last Update Posted (Estimate)

September 9, 2011

Last Update Submitted That Met QC Criteria

September 8, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADENOMA 30-49 YO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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