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

Colorectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01428752
• Other study ID #: ADENOMA 30-49 YO
• Status: Recruiting
• Phase: N/A
• First received: September 2, 2011
• Last updated: September 8, 2011
• Start date: September 2011
• Est. completion date: September 2014

Study information

• Verified date: September 2011
• Source: Asan Medical Center
• Contact: JAEIL KIM, M.D
• Phone: 82230105673
• Email: pianojaeil[@]nate.com
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 49 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence of colorectal adenoma(any size)		First screening colonoscopy	No
Secondary	prevalence of advanced adenoma	Any adenoma =10 mm; Any villous component; High-grade dysplasia	First screening colonoscopy	No