Comparative Effectiveness of Virtual and Optical Colonoscopy for CRC Surveillance

描述(申请人提供)：本申请的目的是比较CT结肠造影术(CTC)和光学结肠镜(OC)在切除后监测环境中检测结肠息肉和癌症的临床效果和成本效益。美国有100多万结直肠癌(CRC)幸存者，每年约有15万新病例。几乎所有人都有资格参加公认的术后监测战略。临床指南建议每年一次腹部/盆腔CT扫描，术后一年进行OC检查，然后每三年进行一次。最近，CTC结合了腹盆内容物的CT成像和腔内结肠成像，作为常规CRC筛查的一种选择引起了人们的关注。我们推测，它也可能被证明是一种成本效益高、临床上有用的替代独立CT扫描和OC作为一种监测技术。在我们的研究中，来自威斯康星大学福克斯·蔡斯癌症中心和梅奥诊所(罗切斯特)的1000名结直肠癌患者，根治性切除一年后，完成了其他癌症治疗，将接受CTC检查，并在同一天进行OC。参与者还将提供关于CTC与单独的成像和内窥镜检查程序的偏好的问卷回答。本研究有三个具体目的：1.以光学结肠镜(OC)为参考标准，评价CT结肠镜(CTC)在结直肠腺瘤和结直肠癌术后监测中的检测特点(敏感性、特异性、阳性预测值和阴性预测值)。2.使用标准的成本-效果分析方法，从付款人和社会的角度比较CTC和独立的OC+CT用于术后监测的成本和结果。3.在术后监测环境中评估患者对CTC的偏好与单独的放射学和内窥镜评估。预计注册时间约为48个月。将存在足够的统计能力来证明CTC相对于OC的敏感度和特异度不低于90%。此外，我们将从付款人和社会的角度建立成本效益模型，调查四氯化碳在术后监测中的作用。数据管理和分析将在福克斯大通完成。CTC的一个重要但很大程度上未被研究的潜在作用是作为术后监测的一个组成部分。如果CTC被发现是一种安全的、临床上与OC相似的替代品，但更具成本效益和/或患者的偏好，这将为将CTC纳入可能治愈的CRC手术后的监测建议提供证据支持。 公共卫生相关性：每年有150,000例新的结直肠癌(CRC)病例和100多万名CRC幸存者。有结直肠癌病史的患者继发结直肠癌的风险较高。该项目将CT结肠镜检查(虚拟结肠镜)与CT和光学结肠镜相结合作为术后监测技术，以更经济有效的方式更早地预防或发现新的结肠癌。

DESCRIPTION (provided by applicant): The objective of this application is to compare the clinical effectiveness and the cost-effectiveness of CT colonography (CTC) to optical colonoscopy (OC) in the detection of colon polyps and cancers in the post- resection surveillance setting. There are more than 1,000,000 survivors of colorectal cancer (CRC) in the US with approximately 150,000 new cases annually. Nearly all are eligible to participate in well accepted post- operative surveillance strategies. Clinical guidelines advocate annual abdominal/pelvic CT scan and OC one year after surgery and then every three years. Recently, CTC which combines CT imaging of abdomino-pelvic contents with intra-luminal colonic imaging has garnered attention as an option for routine CRC screening. We hypothesize it may also prove a cost-effective, clinically useful substitute for independent CT scan and OC as a surveillance technique. In our study, CRC patients (n=1000) from the Fox Chase Cancer Center, University of Wisconsin and the Mayo Clinic (Rochester), one year removed from curative resection, who have completed other cancer therapy, will undergo CTC examination with same day OC to follow. Participants will also provide questionnaire responses regarding preferences about CTC vs. separate imaging and endoscopic procedures. The study has three Specific Aims: 1. To evaluate the test characteristics (sensitivity, specificity, positive and negative predictive value) of CT colonography (CTC) for detecting colorectal adenomas and cancers in the post-resection surveillance setting, using optical colonoscopy (OC) as the reference standard. 2. To compare the costs and outcomes, from the payor's and society's perspectives, of CTC versus independent OC plus CT for post-resection surveillance, using standard methods of cost-effectiveness analysis. 3. To assess patient preference for CTC versus separate radiologic and endoscopic evaluation in the post-resection surveillance setting. Approximately 48 months of enrollment is anticipated. Adequate statistical power will exist to demonstrate that the sensitivity and specificity of CTC are not significantly less than 90% relative to OC. In addition, we will generate cost-effectiveness models from the payor and societal perspectives investigating the role of CTC in post-operative surveillance. Data management and analysis will be completed at Fox Chase. An important, but largely unstudied, potential role for CTC is as a component of post-operative surveillance. If CTC is found to be a safe, clinically similar alternative to OC, but more cost-effective and/or preferred by patients, this would provide evidence based support for incorporation of CTC in surveillance recommendations after potentially curative CRC surgery. PUBLIC HEALTH RELEVANCE: There are 150,000 new cases of colorectal cancer (CRC) annually and over 1 million CRC survivors. Patients with a history of CRC are at elevated risk for subsequent colorectal cancers. This project compares CT colonography (virtual colonoscopy) to the combination of CT plus optical colonoscopy as post-operative surveillance techniques to prevent, or to detect new CRCs earlier and in a more cost-effective manner.