Comparative Effectiveness of Virtual and Optical Colonoscopy for CRC Surveillance

描述（由申请人提供）：本申请的目的是比较CT结肠镜检查（CTC）和光学结肠镜检查（OC）在结肠息肉和癌症切除术后监测中的临床效果和成本效益。在美国，结直肠癌（CRC）的幸存者超过100万，每年约有15万新病例。几乎所有人都有资格参加广为接受的术后监测策略。临床指南提倡每年进行一次腹部/骨盆CT扫描，术后一年进行一次OC检查，然后每三年进行一次。近年来，将腹盆腔内容物的CT成像与腔内结肠成像相结合的CTC作为常规CRC筛查的一种选择受到了关注。我们假设它也可能被证明是一种具有成本效益，临床上有用的替代独立CT扫描和OC作为监测技术。在我们的研究中，来自Fox Chase Cancer Center， University of Wisconsin和Mayo Clinic （Rochester）的CRC患者（n=1000），在根治性切除一年后，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与单独成像和内窥镜手术的偏好的问卷回答。该研究有三个具体目标：1。以光学结肠镜检查（OC）为参考标准，评价CT结肠镜检查（CTC）在结直肠腺瘤和肿瘤切除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. 采用标准的成本-效果分析方法，从支付者和社会的角度比较CTC与独立OC + CT进行术后监测的成本和结果。3. 评估患者对CTC的偏好，而不是在切除后监测环境中进行单独的放射和内镜评估。预计入学时间约为48个月。将存在足够的统计能力来证明CTC相对于OC的敏感性和特异性不显著低于90%。此外，我们将从支付方和社会角度建立成本效益模型，调查CTC在术后监测中的作用。数据管理和分析将在Fox Chase完成。CTC的一个重要但尚未研究的潜在作用是作为术后监测的组成部分。如果发现CTC是一种安全的、临床类似于OC的替代方案，但更具成本效益和/或更受患者青睐，这将为在可能治愈的CRC手术后将CTC纳入监测建议提供基于证据的支持。

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.