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

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ClinicalTrials.gov Identifier: NCT01428752
Recruitment Status : Unknown
Verified September 2011 by Jaeil Kim, Asan Medical Center.
Recruitment status was:  Recruiting
First Posted : September 5, 2011
Last Update Posted : September 9, 2011
Sponsor:
Information provided by (Responsible Party):
Jaeil Kim, Asan Medical Center

Tracking Information
First Submitted Date September 2, 2011
First Posted Date September 5, 2011
Last Update Posted Date September 9, 2011
Study Start Date September 2011
Estimated Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 4, 2011)
prevalence of colorectal adenoma(any size) [ Time Frame: First screening colonoscopy ]
Original Primary Outcome Measures
 (submitted: September 2, 2011)
prevalence of colorectal adenoma(any size) and advanced adenoma [ Time Frame: First screening colonoscopy ]
Change History Complete list of historical versions of study NCT01428752 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 4, 2011)
prevalence of advanced adenoma [ Time Frame: First screening colonoscopy ]
  1. Any adenoma ≥10 mm
  2. Any villous component
  3. High-grade dysplasia
Original Secondary Outcome Measures
 (submitted: September 2, 2011)
prevalence of colorectal cancer [ Time Frame: First screening colonoscopy ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of Prevalence of Colorectal Adenoma in 30- to 49-year-old Subjects With a Family History of Colorectal Cancer
Official Title Prevalence of Colorectal Adenoma in 30- to 49-year-old Asymptomatic Subjects With a First Relative History of Colorectal Cancer
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
whole blood and serum Colorectal polyp/cancer tissue
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
Condition Colorectal Neoplasms
Intervention Not Provided
Study Groups/Cohorts Family history
30- to 49-year-old asymptomatic subjects with a first relative history of colorectal cancer
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: September 2, 2011)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2014
Estimated Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 30 Years to 49 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT01428752
Other Study ID Numbers ADENOMA 30-49 YO
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Jaeil Kim, Asan Medical Center
Study Sponsor Asan Medical Center
Collaborators Not Provided
Investigators
Study Director: Kyung-Jo Kim, M.D Department of Gastroenterology, Asan Medical Center
PRS Account Asan Medical Center
Verification Date September 2011