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

Completed

• Conditions: Colon Polyps; Colorectal Cancer; Adenomatous Polyp of Colon

• Registration Number: NCT02289053
• Lead Sponsor: University of Michigan

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 Description

Not available

Study Timeline

• Study Start: 2006-04-01
• Study First Submitted: 2014-02-26
• Primary Completion: 2014-06-30
• Study Completion: 2014-06-30
• Study First Submitted QC: 2014-11-07
• Study First Posted: 2014-11-13
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-12
• Last Update Posted: 2017-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1623

Inclusion Criteria

• 40-49 year old asymptomatic men and women referred for colorectal cancer screening with a family history of CRC in a first degree relative;
• 40-49 year old asymptomatic men and women referred for colorectal cancer screening with a family history of polyps in a first degree relative;
• 40-49 year old men and women without a family history of CRC or polyps in a first degree relative who are referred for colonoscopy to evaluate scant hematochezia characterized as red blood on toilet tissue after wiping or small droplets of blood on stool or in toilet water after evacuating stool, abdominal discomfort or altered bowel habits characterized as constipation or diarrhea.

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Exclusion Criteria

• Personal history of iron deficiency anemia within six months of referral;
• Personal history of iron deficiency without anemia within six months of referral;
• Personal history of (+) FOBT within one year of referral;
• Personal history of previous colonoscopy or barium enema within the past 10 years;
• Personal history of previous flexible sigmoidoscopy in the past 5 years;
• Personal history of adenoma, colorectal cancer, inflammatory bowel disease, HNPCC, or familial adenomatous polyposis (FAP);
• Unintentional weight loss > 10 lbs within the previous six months;
• Individuals with family history of CRC AND scant hematochezia;
• Inability to speak and read English.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of advanced adenomas among 40-49 year old individuals with and without a family history of colorectal cancer	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.

Secondary Outcome Measures

Name	Time	Method
Absolute prevalence of advanced adenomas in 40-49 year olds with a family history of colorectal cancer	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	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.

Trial Locations

Locations (6)

John D. Dingell VA Medical Center; 🇺🇸 Detroit, Michigan, United States

Huron Gastro; 🇺🇸 Ypsilanti, Michigan, United States

Walter Reed National Military Medical Center; 🇺🇸 Bethesda, Maryland, United States

Ann Arbor VA Healthcare System; 🇺🇸 Ann Arbor, Michigan, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Durham VA Medical Center; 🇺🇸 Durham, North Carolina, United States