Status:
COMPLETED
Prevalence and Topography of Adenomas in 40-49 Year Old Patients With a Family History of Colon Cancer
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Colorectal Cancer
Colon Polyps
Eligibility:
All Genders
40-49 years
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 ad...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2014
Estimated Enrollment :
1623 Patients enrolled
Trial Details
Trial ID
NCT02289053
Start Date
April 1 2006
End Date
June 30 2014
Last Update
May 15 2017
Active Locations (6)
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1
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
2
Ann Arbor VA Healthcare System
Ann Arbor, Michigan, United States, 48105
3
University of Michigan
Ann Arbor, Michigan, United States, 48109
4
John D. Dingell VA Medical Center
Detroit, Michigan, United States, 48201