Colon Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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.

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.

Study is for people with:

Colon Cancer

Estimated Enrollment:

1623

Study ID:

NCT02289053

Recruitment Status:

Completed

Sponsor:

University of Michigan

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There are 6 Locations for this study

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Walter Reed National Military Medical Center
Bethesda Maryland, 20889, United States
Ann Arbor VA Healthcare System
Ann Arbor Michigan, 48105, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
John D. Dingell VA Medical Center
Detroit Michigan, 48201, United States
Huron Gastro
Ypsilanti Michigan, 48197, United States
Durham VA Medical Center
Durham North Carolina, 27705, United States

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Estimated Enrollment:

1623

Study ID:

NCT02289053

Recruitment Status:

Completed

Sponsor:


University of Michigan

How clear is this clinincal trial information?

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