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

Completed

Conditions studied: Colorectal Cancer, Colon Polyps, Adenomatous Polyp of Colon

In brief

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.

Key facts

Study ID

NCT02289053

Run by

University of Michigan

People needed

1623

Starts

2006-04-01

Expected to finish

2014-06-30

Last updated by the study team

2017-05-15

Who can join

Age: 40 and older, up to 49. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• John D. Dingell VA Medical Center — Detroit, Michigan, United States
• Huron Gastro — Ypsilanti, Michigan, United States
• Durham VA Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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