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

• Conditions: Colorectal Neoplasms

• Registration Number: NCT01428752
• Lead Sponsor: Asan Medical Center

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

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 Timeline

• Status Verified: 2011-09
• Study Start: 2011-09
• Study First Submitted: 2011-09-02
• Study First Submitted QC: 2011-09-02
• Study First Posted: 2011-09-05
• Last Update Submitted: 2011-09-08
• Last Update Posted: 2011-09-09
• Primary Completion: 2014-09
• Study Completion: 2014-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
prevalence of colorectal adenoma(any size)	First screening colonoscopy

Secondary Outcome Measures

Name	Time	Method
prevalence of advanced adenoma	First screening colonoscopy	1. Any adenoma ≥10 mm; 2. Any villous component; 3. High-grade dysplasia

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of