Comparative Effectiveness of Virtual and Optical Colonoscopy for CRC Surveillance

虚拟结肠镜检查和光学结肠镜检查在结直肠癌监测中的效果比较

基本信息

批准号：
8688932
负责人：
DAVID S WEINBERG
金额：
$ 66.9万
依托单位：
RESEARCH INST OF FOX CHASE CAN CTR
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-07-19 至 2016-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8688932
关键词：
Abdomen Address Adenomatous Polyps Adherence Advocate Attention Cancer Patient Cancer Survivor Characteristics Clinic Clinical Clinical Trials Clinical effectiveness Colon Colon Carcinoma Colonic Polyps Colonoscopy Colorectal Adenoma Colorectal Cancer Colorectal Polyp Computed Tomographic Colonography Cost Effectiveness Analysis Data Data Analyses Detection Diagnosis Disease Distant Metastasis Dose Early identification Enrollment Evaluation Excision Fox Chase Cancer Center Foxes Goals Guidelines Image Imagery Laboratories Malignant Neoplasms Methods Metric Modeling Molecular Chaperones Neoplasms Operative Surgical Procedures Optics Outcome Participant Patient Preferences Patients Pelvis Performance Physical Examination Postoperative Period Predictive Value Procedures Quality of Care Quality of life Questionnaires Radiation Recommendation Recording of previous events Recurrence Reference Standards Relative (related person)Retrospective Studies Risk Role Scanning Schedule Sedation procedure Sensitivity and Specificity Societies Surveillance Program Surveys Survivors Techniques Technology Testing Therapeutic Intervention Third-Party Payer Time Universities Wisconsin X-Ray Computed Tomography base cancer surgery cancer therapy colorectal cancer screening comparative effectiveness compliance behavior cost cost effective cost effectiveness data management diagnostic accuracy evidence base image reconstruction improved preference prevent response surveillance strategy virtual

项目摘要

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.

描述（由申请人提供）：本申请的目的是比较 CT 结肠成像 (CTC) 与光学结肠镜检查 (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。美国有超过 1,000,000 名结直肠癌 (CRC) 幸存者，每年新增病例约 150,000 例。几乎所有人都有资格参与广为接受的术后监测策略。临床指南提倡术后一年每年进行一次腹部/盆腔 CT 扫描和 OC，然后每三年一次。最近，将腹盆腔内容物 CT 成像与腔内结肠成像相结合的 CTC 作为常规 CRC 筛查的一种选择引起了人们的关注。我们假设它也可能被证明是一种经济高效、临床有用的独立 CT 扫描和 OC 作为监测技术的替代品。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 CRC 患者（n = 1000），在治愈性切除一年后，已完成其他癌症治疗，将在同一天接受 CTC 检查OC 跟随。参与者还将提供有关 CTC 与单独成像和内窥镜手术偏好的调查问卷答复。该研究有三个具体目标： 1. 使用光学结肠镜检查 (OC) 评估 CT 结肠成像 (CTC) 在切除后监测环境中检测结直肠腺瘤和癌症的测试特征（敏感性、特异性、阳性和阴性预测值））作为参考标准。 2. 使用成本效益分析的标准方法，从支付方和社会的角度比较 CTC 与独立 OC 加 CT 进行术后监测的成本和结果。 3. 评估患者在切除后监测环境中对 CTC 的偏好与单独的放射学和内窥镜评估的偏好。预计入学时间约为 48 个月。存在足够的统计功效来证明 CTC 的敏感性和特异性相对于 OC 不显着低于 90%。此外，我们将从付款人和社会角度生成成本效益模型，调查 CTC 在术后监测中的作用。数据管理和分析将在福克斯蔡斯完成。 CTC 的一个重要但基本上未被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、临床上与 OC 类似的替代方案，但更具成本效益和/或患者更喜欢，这将为将 CTC 纳入潜在治愈性 CRC 手术后的监测建议提供基于证据的支持。