Colon Polyp Screening with Colonoscopy in Women

女性结肠息肉筛查

• 批准号: 6368131
• 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/6368131
• 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筛选技术 大肠息肉患者。尽管国家息肉研究表明 内窥镜下切除结肠息肉可降低结直肠癌死亡率 筛查结肠息肉的最有效技术正在争论中。最近，退伍军人事务部 合作研究380(N Engl J Med 2000；343：162-8)筛查无症状美国 退伍军人结肠息肉结肠镜检查。10%的美国退伍军人已经进入 大肠息肉(即直径10 mm的腺瘤，高级别腺瘤 不典型增生、绒毛状腺瘤或结直肠癌)。在患有NO的患者中 在远端结肠腺瘤中，大约4%的人有晚期息肉 近端结肠。因此，结肠镜检查可能是一种比 FS。然而，VA 380是在97%的男性人群中进行的，男性可能 比女性更易发展为晚期结肠息肉(OR=3.3)。 因此，我们目前正在进行VA 380的串联试验(称为 关注试验)在妇女中。 对于这个职业发展奖，我将完成关注审判，a 结肠镜检查筛查效果的多中心试验 无症状女性大肠息肉(研究1)。几个子研究也是 正在进行：调查问卷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)，以及 血浆，白细胞，大肠息肉组织的石蜡切片，以及大肠息肉的夹检 正常的结肠粘膜将被收集并储存在血液/组织储存库中 (研究3)。在这个职业发展奖的第三年，来自关注的数据 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)。我谦虚地指出，这个计划可能也会出现 野心勃勃。然而，Concern试验已经完成了40%以上的患者 注册和问卷数据以及血液/组织样本已经 收集了所有研究患者的数据，表明完成研究1-3是 很有可能。 作为这个职业发展奖的一部分，我希望能发展出更好的 了解癌症遗传学的流行病学并开展合作 与专家一起研究结直肠癌的分子标志物。发展中 这些技能和协作将指导有关血液利用的决定 以及从忧心忡忡的试验患者那里获得的组织。此外，这些 经验和协作将促进翻译的设计 研究，将实验室的发现带到以患者为中心的试验中。 进一步的课程学习和指导将帮助我了解 大型临床试验设计的成本-效果分析及相关问题 审判。最终，建议的研究性研究、教学课程和 希望指导将导致成功的R01申请。