Comparative Effectiveness of Virtual and Optical Colonoscopy for CRC Surveillance

描述（由申请方提供）：本申请的目的是比较CT结肠成像（CTC）与光学结肠镜（OC）在切除术后监测环境中检测结肠息肉和癌症的临床有效性和成本效益。在美国有超过1，000，000名结直肠癌（CRC）幸存者，每年约有150，000例新发病例。几乎所有的人都有资格参加广泛接受的术后监测策略。临床指南提倡每年一次腹部/盆腔CT扫描和术后一年OC，然后每三年一次。最近，CTC结合了腹腔盆腔内容物的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。我们假设它也可能被证明是一种具有成本效益的，临床上有用的替代独立的CT扫描和OC作为一种监测技术。 在我们的研究中，来自福克斯蔡斯癌症中心、威斯康星州大学和马约诊所（罗切斯特）的CRC患者（n=1000），根治性切除术后一年，完成其他癌症治疗，将接受CTC检查，并在同一天进行OC。参与者还将提供关于CTC与单独成像和内窥镜程序的偏好的问卷回答。 本研究有三个具体目标：1。以光学结肠镜（OC）为参考标准，评价CT结肠成像（CTC）在结直肠腺瘤和癌切除术后监测中的检测特性（敏感性、特异性、阳性预测值和阴性预测值）。 2.从支付者和社会的角度，使用标准的成本效益分析方法，比较CTC与独立的OC加CT用于切除术后监测的成本和结果。 3.在切除术后监测环境中，评估患者对CTC与单独的放射学和内窥镜评价的偏好。 预计入组约48个月。将存在足够的统计功效来证明CTC相对于OC的灵敏度和特异性不显著低于90%。此外，我们还将从支付者和社会的角度研究CTC在术后监测中的作用，从而建立成本效益模型。数据管理和分析将在Fox Chase完成。 一个重要的，但在很大程度上未经研究，CTC的潜在作用是作为术后监测的一个组成部分。如果发现CTC是一种安全的、临床上类似于OC的替代方案，但更具成本效益和/或受患者青睐，这将为在潜在治愈性CRC手术后将CTC纳入监测建议提供基于证据的支持。 公共卫生相关性：每年有150，000例结直肠癌（CRC）新发病例，超过100万例CRC幸存者。有结直肠癌病史的患者发生结直肠癌的风险较高。该项目将CT结肠成像（虚拟结肠镜）与CT+光学结肠镜的组合作为术后监测技术进行比较，以预防或更早地以更具成本效益的方式检测新的CRC。

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.