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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
History of Changes
  Purpose

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


Condition
Colorectal Neoplasms

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of Colorectal Adenoma in 30- to 49-year-old Asymptomatic Subjects With a First Relative History of Colorectal Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • prevalence of colorectal adenoma(any size) [ Time Frame: First screening colonoscopy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Biospecimen Retention:   Samples Without DNA

whole blood and serum Colorectal polyp/cancer tissue


Estimated Enrollment: 1000
Study Start Date: September 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Family history
30- to 49-year-old asymptomatic subjects with a first relative history of colorectal cancer

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).

  Eligibility

Ages Eligible for Study:   30 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01428752

Contacts
Contact: JAEIL KIM, M.D 82230105673 pianojaeil@nate.com
Contact: KYUNG-JO KIM, M.D 82230103196 capsulendos@gmail.com

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Kyung-Jo Kim, M.D     82230103196     capsulendos@gmail.com    
Contact: Jaeil Kim, M.D     82230105673     pianojaeil@nate.com    
Sponsors and Collaborators
Asan Medical Center
Investigators
Study Director: Kyung-Jo Kim, M.D Department of Gastroenterology, Asan Medical Center
  More Information

No publications provided

Responsible Party: Jaeil Kim, Clinical Assistant Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01428752     History of Changes
Other Study ID Numbers: ADENOMA 30-49 YO
Study First Received: September 2, 2011
Last Updated: September 8, 2011
Health Authority: Korea: Institutional Review Board

Keywords provided by Asan Medical Center:
colonoscopy
colorectal neoplasms
screening
family history

Additional relevant MeSH terms:
Colorectal Neoplasms
Adenoma
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Intestinal Neoplasms
Gastrointestinal Neoplasms
 Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on June 18, 2013