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

University of Michigan

Status: Completed

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

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02289053

1K24DK084208 (U.S. NIH Grant/Contract)

K24-DK

Details and patient eligibility

About

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.

Enrollment: 1,623 patients

Sex: All

Ages: 40 to 49 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

1,623 participants in 2 patient groups

Positive Family History

Description:

Eligible participants with a family history of colorectal cancer or polyps will be grouped into the "subjects" group.

Average Risk Patients

Description:

Eligible participants without a family history of colorectal cancer or polyps will be grouped into the "control" group.