Colon Polyp Screening with Colonoscopy in Women

女性结肠息肉筛查

• 批准号: 6777075
• 负责人: PHILIP S SCHOENFELD
• 金额: $ 11.57万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-20 至 2006-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6777075
• 关键词: bioimaging /biomedical imaging; biopsy; cancer risk; clinical trials; colon polyp; colorectal neoplasms; cost effectiveness; endoscopy; female; gastrointestinal imaging /visualization; human subject; mass screening; patient oriented research; questionnaires; tissue resource /registry; women' s health

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.

描述（由申请人提供） 我的长期职业目标是找出最有效的技术来筛选 结肠息肉的患者。虽然国家息肉研究表明， 内镜下切除结肠息肉可降低结直肠癌死亡率， 最有效的技术来筛选结肠息肉是有争议的。最近，VA 合作研究380（N Engl J Med 2000; 343：162-8）筛查无症状美国 结肠镜检查结肠息肉的退伍军人。10%的美国退伍军人 结肠息肉（即，腺瘤直径> 10 mm，高级别腺瘤 发育不良、绒毛状腺瘤或结肠直肠癌）。在没有 在远端结肠腺瘤中，大约4%的患者在远端结肠有晚期息肉。 近端结肠因此，结肠镜检查可能是一个更有效的筛查工具， FS.然而，VA 380是在97%的男性人群中进行的， 更有可能（OR = 3.3）发展为晚期结肠息肉比女性。 因此，我们目前正在进行VA 380的串联试验（称为 CONCERN试验）。 为了这个职业发展奖，我将完成CONCERN试验， 关于结肠镜筛查有效性的多中心试验 结肠息肉的无症状女性（研究#1）。几个子研究也 正在进行：问卷调查将评估环境和饮食因素 这可能与结肠息肉的发展有关（研究#2），和 血浆、WBC、结肠息肉组织的石蜡块，以及 将收集正常结肠粘膜并储存在血液/组织储存库中 （研究#3）。在这个职业发展奖的第三年，来自CONCeRN的数据 试验将为筛查的成本效益分析提供基础 女性结肠镜检查（研究#4）。我谦卑地指出，这个计划可能也会出现 雄心勃勃然而，CONCeRN试验已经完成了超过40%的患者 登记和问卷数据以及血液/组织样本已经 收集所有研究患者的数据，表明完成研究1-3 很有可能。 作为这个职业发展奖的一部分，我希望能发展一个更好的 了解癌症遗传学的流行病学并开展合作 与研究结直肠癌分子标志物的专家进行了交流。发展中 这些技能和协作将指导关于血液利用的决策， 和CONCeRN试验患者的组织库。而且这些 经验和合作将促进翻译的设计 研究，从实验室的结果，以病人为导向的试验。 进一步的课程和指导将帮助我了解 大型临床试验设计的成本效益分析和相关问题 审判最终，拟议的研究，教学课程， 希望指导会导致成功的R 01应用程序。