Risk of Cancer with Incidental Findings Identified on Ultrasound Imaging

超声成像偶然发现的癌症风险

基本信息

批准号：
7660553
负责人：
REBECCA SMITH-BINDMAN
金额：
$ 22.02万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-04-01 至 2011-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7660553
关键词：
Accounting Age Anatomy Anxiety Benign Blood Vessels Breast CA-125 Antigen Categories Characteristics Clinical Cohort Analysis Collection Cyst Data Databases Detection Development Diagnosis Diagnostic Diagnostic Imaging Diagnostic radiologic examination Diagnostic tests Disease Early Diagnosis Early identification Enrollment Equilibrium Evaluation Family history of Female Financial cost Frequencies Funding Goals Guidelines Health Healthcare Systems Hemorrhage Image Imaging technology Incidental Findings Individual Laboratories Lead Lesion Link Magnetic Resonance Imaging Malignant Neoplasms Malignant neoplasm of ovary Mammography Master&apos s Degree Medical Medical Imaging Methodology Minority Ovarian Cysts Ovary Pain Pathology Patients Pattern Pelvis Physicians Prevalence Records Reporting Research Research Project Grants Resolution Risk Risk Factors Screening for Ovarian Cancer Serum Solid Standardization Students Symptoms System Testing Time Ultrasonography Uncertainty Vagina Vertebral column Visit Washington base cancer diagnosis cancer risk cancer type clinically significant cohort cost design driving force evidence base evidence based guidelines falls follow-up improved medical specialties member population based public health relevance radiologist research study statistics trend tumor registry

项目摘要

DESCRIPTION (provided by applicant): The use of diagnostic imaging has increased dramatically over the last 10 years. Concurrently, spectacular advances in imaging technology have allowed the detection of increasingly smaller anatomic lesions. The positive impact of these changes on the earlier and more precise diagnosis of a broad range of medical diseases cannot be overstated. However, one unavoidable consequence of the increased utilization and resolution of imaging is the diagnosis of increasing numbers of incidental findings (unexpected, asymptomatic findings) and indeterminate findings (findings related to the reason for imaging, but of unknown clinical significance). Although the risk of pathology associated with these lesions is considered low, uncertainty regarding their clinical significance and lack of guidelines for their management leads to extensive further testing and surveillance. While the identification and evaluation of these incidental/indeterminate findings may lead to the earlier identification and treatment of an occult malignancy, they also involve high costs due to additional physician visits and follow-up testing, as well as harms, such as anxiety, complications from further testing and unnecessary treatment. Although anecdotally radiologists have reported a rise in the how frequently imaging tests are obtained to further evaluate such lesions, the true frequency of these findings and the risk of cancer associated with specific incidental/indeterminate findings is unknown. Consequently, little evidence-based data are available to guide the management of these findings. The aims of the proposed study are 1) to identify the indications that led to ultrasound imaging of the pelvis 2) to evaluate the prevalence of specific ultrasound morphological findings on these examinations and determine the risk of cancer and other accuracy statistics associated with a range of ultrasound findings (including benign appearing incidental findings, numerous indeterminate finding and suspicious findings). The risk of cancer associated with specific ultrasound findings will be calculated unadjusted and stratified for important patient factors (such as age, cancer risk factors including a family history of breast and ovarian cancer and Serum CA-125 levels) and then adjusted for important confounders. In order to complete this aim, we will first categorize the results of all ultrasound examinations and then calculate the risk of cancer by the type of lesion. Lastly for Aim 3) we will evaluate surveillance patterns following the identification of specific findings. The purpose of this aim is to help provide data on the costs of surveillance to balance the potential benefits of the identification of such lesions. This proposal focuses on ultrasound imaging, as after radiography (x-ray), ultrasound accounts for the largest proportion of imaging tests performed, and incidental/indeterminate findings are frequently identified on these examinations. The results of these analyses will clarify the magnitude of this problem by providing data on how frequently incidental findings are identified and further, will provide data on the risk of cancer associated with specific findings. To complete these aims, we will conduct a retrospective cohort analysis of patients enrolled in Group Health, a large not-for-profit healthcare system in Seattle Washington, whose 260,000 female members underwent over 110,000 ultrasound examinations over the years of the study (1997 - 2005). Group Health collects and stores automated and detailed clinical records of diagnostic testing, and these data are routinely linked with regional SEER tumor registry data. Further, detailed data on ovarian cancer risk factors are available for all enrollees. Using this large, population-based database, we will complete the aims, and the results of these analyses will inform the development of evidence-based guidelines for the management of findings identified on ultrasound imaging of the pelvis. PUBLIC HEALTH RELEVANCE: Over the last decade the utilization of medical imaging has increased dramatically. Concurrently, spectacular advances in imaging technology have allowed the detection of increasingly smaller anatomic lesions. The positive impact of these changes on the earlier and more precise diagnosis of a broad range of medical diseases cannot be overstated. However, one unavoidable consequence of the increased utilization and resolution of imaging is the diagnosis of increasing numbers of incidental and indeterminate findings. Although the risk of pathology associated with these lesions is considered very low, uncertainty regarding their clinical significance and lack of guidelines for their management can initiate extensive further testing and surveillance. The aims of the proposed research are to identify the prevalence of incidental/indeterminate associated with ultrasound imaging, and to evaluate the risk of cancer associated with specific ultrasound finings identified in the pelvis. The goal is to develop management strategies for these incidental findings that will maximize the detection of occult cancer, while minimizing unnecessary imaging surveillance.

描述（由申请人提供）：在过去的10年中，诊断成像的使用急剧增加。同时，成像技术的壮观进步允许检测越来越小的解剖病变。这些变化对早期和更精确的多种医疗疾病诊断的积极影响不能被夸大。然而，成像的利用率增加和分辨率的一个不可避免的后果是诊断偶然发现数量增加（意外，无症状发现）和不确定的发现（发现与成像的原因相关的发现，但临床意义却未知）。尽管与这些病变相关的病理风险被认为是较低的，但其临床意义的不确定性以及缺乏管理指南会导致广泛的进一步测试和监视。虽然对这些偶然/不确定发现的识别和评估可能会导致对神秘恶性肿瘤的较早识别和治疗，但由于额外的医师就诊和随访测试以及危害，例如焦虑，并发症，进一步测试和不必要的治疗，它们也涉及高成本。尽管广泛的放射科医生报告说，获得进一步评估此类病变的成像测试的频率有所增加，但这些发现的真实频率以及与特定的偶然/不确定发现相关的癌症风险尚不清楚。因此，很少有基于证据的数据可以指导这些发现的管理。拟议研究的目的是1）确定导致骨盆超声成像的迹象2）评估这些检查中特定超声形态发现的普遍性，并确定癌症的风险和其他与一系列超声检查结果相关的准确性统计数据（包括良性出现的事故发现，包括不确定的发现和可疑发现）。将对重要患者因素（例如年龄，癌症风险因素，包括乳腺癌和卵巢癌的家族病史以及血清CA-125水平）计算与特定超声发现相关的癌症风险，然后对重要的混杂因素进行调整。为了完成此目标，我们将首先对所有超声检查的结果进行分类，然后通过病变类型来计算癌症的风险。最后，目标3）我们将在确定特定发现后评估监视模式。此目的的目的是帮助提供有关监视成本的数据，以平衡识别此类病变的潜在收益。该提案的重点是超声成像，因为在X射线照相术（X射线）之后，超声是执行成像测试比例最大的，并且在这些检查中经常发现偶然/不确定的发现。这些分析的结果将通过提供有关偶然发现的频率的数据，并将提供有关与特定发现相关的癌症风险的数据，从而阐明了此问题的幅度。为了完成这些目标，我们将对参加团体健康的患者进行回顾性队列分析，该研究是在西雅图华盛顿的大型非营利性医疗保健系统，在研究的年度（1997年至2005年），她的260,000名女性成员接受了110,000多名超声检查。小组健康收集和存储诊断测试的自动化和详细的临床记录，这些数据通常与区域SEER肿瘤注册表数据联系起来。此外，所有参与者都可以使用有关卵巢癌风险因素的详细数据。使用这个基于人群的大型数据库，我们将完成目标，这些分析的结果将为制定基于证据的指南，以管理骨盆超声成像确定的发现。公共卫生相关性：在过去的十年中，医学成像的利用急剧增加。同时，成像技术的壮观进步允许检测越来越小的解剖病变。这些变化对早期和更精确的多种医疗疾病诊断的积极影响不能被夸大。但是，成像的利用率和分辨率增加的一个不可避免的结果是诊断偶然和不确定的发现数量增加。尽管与这些病变相关的病理风险被认为是非常低的，但对其临床意义以及缺乏管理指南的不确定性可以启动广泛的进一步测试和监视。拟议的研究的目的是确定与超声成像相关的偶然/不确定的患病率，并评估与骨盆中确定的特定超声罚款相关的癌症风险。目的是为这些偶然发现制定管理策略，以最大程度地发现隐匿性癌症的检测，同时最大程度地减少不必要的成像监视。