Clinical Trial: Prevalence and Topography of Adenomas in 40-49 Year Old Patients With a Family History of Colon Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Prevalence and Topography of Adenomas in 40-49 Year Old Patients With a Family History of Colon Cancer

Brief Summary: Conflicting guideline recommendations for screening colonoscopy result due to scant data upon which to develop appropriate recommendations. No previous study has compared the prevalence of advanced adenomas or adenomas (any size) among 40-49 year old individuals with a first degree relative (FDR) with colorectal cancer (CRC) versus 40-49 year old average risk individuals with no family history of CRC. The purpose of this study is to determine the prevalence of colon adenomas in 40-49 year old individuals and identify risk factors associated with the presence of advanced adenomas. This data will provide evidence to determine appropriate colon cancer screening guidelines in 40-49 year old persons with a family history of colon polyps or colorectal cancer.

Detailed Summary:
Sponsor: University of Michigan

Current Primary Outcome: Prevalence of advanced adenomas among 40-49 year old individuals with and without a family history of colorectal cancer [ Time Frame: Data analysis will begin September 2014 for a duration of three months. ]

The outcome will be assessed after the completion of patient recruitment at all locations in August 2014. Advanced adenomas are defined as greater than or equal to 10 mm (1 cm). The presence of adenomas is determined be reviewing patient medical records and pathology reports.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Absolute prevalence of advanced adenomas in 40-49 year olds with a family history of colorectal cancer [ Time Frame: Data analysis will begin September 2014 for a duration of three months. ]
    The outcome will be assessed after the completion of patient recruitment at all locations in August 2014. Advanced adenomas are defined as greater than or equal to 10 mm (1 cm). The presence of adenomas is determined be reviewing patient medical records and pathology reports.
  • Absolute prevalence of advanced adenomas in 40-49 year old individuals with a family history of colorectal polyps [ Time Frame: Data analysis will begin September 2014 for a duration of three months. ]
    The outcome will be assessed after the completion of patient recruitment at all locations in August 2014. Advanced adenomas are defined as greater than or equal to 10 mm (1 cm). The presence of adenomas is determined be reviewing patient medical records and pathology reports.


Original Secondary Outcome: Same as current

Information By: University of Michigan

Dates:
Date Received: February 26, 2014
Date Started: April 1, 2006
Date Completion:
Last Updated: May 12, 2017
Last Verified: May 2017