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

This study is currently recruiting participants.
Verified September 2011 by Asan Medical Center
Sponsor:
Information provided by (Responsible Party):
Jaeil Kim, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01428752
First received: September 2, 2011
Last updated: September 8, 2011
Last verified: September 2011

September 2, 2011
September 8, 2011
September 2011
September 2014   (final data collection date for primary outcome measure)
prevalence of colorectal adenoma(any size) [ Time Frame: First screening colonoscopy ] [ Designated as safety issue: No ]
prevalence of colorectal adenoma(any size) and advanced adenoma [ Time Frame: First screening colonoscopy ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01428752 on ClinicalTrials.gov Archive Site
prevalence of advanced adenoma [ Time Frame: First screening colonoscopy ] [ Designated as safety issue: No ]
  1. Any adenoma ≥10 mm
  2. Any villous component
  3. High-grade dysplasia
prevalence of colorectal cancer [ Time Frame: First screening colonoscopy ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of Prevalence of Colorectal Adenoma in 30- to 49-year-old Subjects With a Family History of Colorectal Cancer
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

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).

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

whole blood and serum Colorectal polyp/cancer tissue

Non-Probability Sample

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

Colorectal Neoplasms
Not Provided
Family history
30- to 49-year-old asymptomatic subjects with a first relative history of colorectal cancer
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
September 2014
September 2014   (final data collection date for primary outcome measure)

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
Both
30 Years to 49 Years
No
Contact: JAEIL KIM, M.D 82230105673 pianojaeil@nate.com
Contact: KYUNG-JO KIM, M.D 82230103196 capsulendos@gmail.com
Korea, Republic of
 
NCT01428752
ADENOMA 30-49 YO
Yes
Jaeil Kim, Asan Medical Center
Asan Medical Center
Not Provided
Study Director: Kyung-Jo Kim, M.D Department of Gastroenterology, Asan Medical Center
Asan Medical Center
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP