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

• 批准号: 8304194
• 负责人: DAVID S WEINBERG
• 金额: $ 65.77万
• 依托单位: FOX CHASE CANCER CENTER
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-07-19 至 2013-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8304194
• 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

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结肠造影（CTC）与光学结肠镜检查（OC）的临床有效性和成本效益，以检测结肠息肉和癌症在切除后的检查环境中。美国有大约15万例新病例的结直肠癌（CRC）的幸存者超过100万。几乎所有人都有资格参加公认的手术后监视策略。临床指南提倡年度腹部/骨盆CT扫描和OC在手术后一年，然后每三年一次。最近，将腹-ino-Pelvic含量与灯内结肠成像的CT成像结合在一起的CTC引起了人们的注意，作为常规CRC筛查的一种选择。我们假设它也可能证明是一种具有成本效益的临床有用的替代品，用于独立的CT扫描和OC作为监视技术。 在我们的研究中，来自威斯康星大学Fox Chase Cancer Center和Mayo Clinic（Rochester）的CRC患者（n = 1000），从治疗切除术中删除了一年，他们已经完成了其他癌症治疗，将接受当天OC进行CTC检查。参与者还将提供有关CTC与单独成像和内窥镜程序的偏好的问卷回答。 该研究具有三个具体目的：1。评估CT结肠造影（CTC）（CTC）的测试特征（敏感性，特异性，正和阴性预测价值），以使用光学结肠镜检查（OC）作为参考标准来检测切除后监视设置中结直肠腺瘤和癌症。 2。使用标准的成本效益分析的标准方法，从付款人和社会的角度比较了CTC与独立OC加CT的成本和成果，以进行切除后监视。 3。评估患者对CTC的偏好与分离后监视环境中的单独的放射学和内窥镜评估。 预计将大约48个月的入学人数。将存在足够的统计能力，以证明CTC的敏感性和特异性相对于OC的敏感性和特异性显着少于90％。此外，我们将从付款人和社会角度生成成本效益模型，以调查CTC在术后监视中的作用。数据管理和分析将在Fox Chase完成。 CTC的重要但很大程度上没有研究的潜在作用是术后监视的组成部分。如果发现CTC是与OC的安全，临床上相似的替代方案，但患者更具成本效益和/或更具成本效益，这将提供基于证据的支持，以在潜在的治疗性CRC手术后将CTC纳入监视建议中。