Colon Polyp Screening with Colonoscopy in Women

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DESCRIPTION (provided by applicant) My long term career goal is to identify the most effective techniques to screen patients for colonic polyps. Although the National Polyp Study indicated that endoscopic removal of colon polyps reduces colorectal cancer mortality, the most effective technique to screen for colon polyps is debated. Recently, VA Cooperative Study 380 (N Engl J Med 2000; 343: 162-8) screenedasymptomatic US Veterans for colonic polyps with colonoscopy. 10% of US Veterans had advanced colonic polyps (i.e., adenomas > 10 mm in diameter, adenomas with high grade dysplasia, villous adenomas, or colorectal cancer). Among patients with no adenomas in the distal colon, approximately 4% had an advanced polyp in the proximal colon. Thus, colonoscopy may be a more effective screening tool than FS. However, VA 380 was conducted in a 97% male population, and men may are more likely (OR = 3.3) to develop advanced colonic polyps than women. Therefore, we are currently conducting a tandem trial of VA 380 (called the CONCeRN Trial) in women. For this career development award, I will complete the CONCeRN Trial, a multi-center trial about the effectiveness of colonoscopy to screen asymptomatic women for colonic polyps (Study #1). Several sub-studies are also being performed: questionnaires will assess environmental and dietary factors which may be associated with the development of colonic polyps (Study #2), and plasma, WBC, paraffin blocks of colonic polyp tissue, and pinch biopsies of normal colonic mucosa will be collected and banked in a blood/tissue repository (Study #3). In year 3 of this career development award, data from the CONCeRN Trial will provide the basis for a cost-effectiveness analysis of screening colonoscopy in women (Study #4). I humbly note that this plan may appear too ambitious. However, the CONCeRN Trial has already completed over 40% of patient enrollment and questionnaire data and blood/tissue samples are already collected on all study patients, suggesting that completion of Studies 1-3 is likely. As part of this career development award, I hope to develop a better understanding of the epidemiology of cancer genetics and develop collaborations with experts investigating molecular markers of colorectal cancer. Developing these skills and collaborations will guide decisions about utilization of blood and tissue that has been banked from CONCeRN Trial patients. Furthermore, these experiences and collaborations will facilitate the design of translational reseach, taking findings from the laboratory to patient-oriented trials. Further coursework and mentoring will help me understand the performance of cost-effectiveness analysis and issues related to the design of large clinical trials. Ultimately, the proposed research studies, didactic coursework, and mentoring hopefully will lead to successful R01 applications.