Comparative Risk of Endometrial Cancer from Ablation Versus Medical Management

子宫内膜癌消融与药物治疗的风险比较

• 批准号: 8283124
• 负责人: BRIAN LESLIE STROM
• 金额: $ 9.76万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-03-01 至 2013-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8283124
• 关键词: Comparative; Risk; Endometrial; Cancer; Ablation

DESCRIPTION (provided by applicant): Abnormal menstruation, often caused by Dysfunctional Uterine Bleeding (DUB), is one of the most common chief complaints to gynecologists and family practices, and is associated with significant morbidity and costs to patients and the healthcare system. First-line treatments include medical management with hormones and other medications and endometrial ablation procedures. Beneficial effects of first line treatments have been well-studied and shown to have few differences when compared past one year. However, a comparative effectiveness approach to adverse events, including endometrial cancer, has not been performed. This is vitally important to patient decision-making and is necessary to establish quality healthcare delivery, given that guidelines for DUB treatment are mixed or absent. Cancer (an AHRQ priority disease) is a pressing outcome for women with DUB because obesity (an AHRQ priority condition) and advancing age (representing the AHRQ priority population of women and the elderly) increases risk for both DUB and endometrial cancer. Objectives and Specific Aims - The overall objective is to optimize the care for DUB by performing a comparative effectiveness study among alternative treatments. The study will have a specific focus on endometrial cancer as the outcome. Specific Aim 1 assesses if endometrial ablation versus medical management carries an increased risk of endometrial cancer. Specific Aim 2 investigates if cancer diagnosis is delayed in women who underwent ablation vs. medical management. Finally, Specific Aim 3 investigates if women who undergo ablation present with a higher surgical stage of endometrial cancer versus those who choose medical management and develop endometrial cancer. Research Design and Methods A retrospective cohort study will be performed in The Health Improvement Network (THIN), a UK medical record database with over 600,000 women with a diagnosis of DUB, who received either endometrial ablation or medical management. The study will report both unadjusted results and results adjusted for possible confounders. It will examine the relative risk of endometrial cancer using Cox proportional hazard models~ it will investigate diagnostic delay by comparing median time from DUB diagnosis to cancer diagnosis between treatment groups~ and it will compare the proportion of stage I endometrial cancers between treatment groups. Impact Results from the study could profoundly influence both treatment paradigms for DUB and screening regimens for endometrial cancer. PUBLIC HEALTH RELEVANCE: The proposed study will compare the effectiveness of endometrial ablation procedures versus management with medications for one of the most common causes of abnormal menstrual bleeding. It is designed to study differences in cancer of the womb (endometrium) by comparing the risk of cancer, the delay in diagnosis of cancer, and the severity of each cancer between these treatment groups. This will help women make informed decisions regarding their treatment options for abnormal menstrual bleeding, and help physicians make proper guidelines and recommendations for cancer monitoring and treatment.

描述（由申请人提供）：月经异常，通常由功能失调性子宫出血（DUB）引起，是妇科医生和家庭医生最常见的主诉之一，并与患者和医疗保健系统的显著发病率和成本相关。一线治疗包括激素和其他药物的药物管理和子宫内膜消融术。一线治疗的有益效果已得到充分研究，并显示与过去一年相比几乎没有差异。然而，尚未对包括子宫内膜癌在内的不良事件进行比较有效性研究。这对患者的决策至关重要，并且对于建立高质量的医疗保健服务是必要的，因为DUB治疗的指南是混合的或不存在的。癌症（AHRQ优先疾病）是DUB女性的一个紧迫结果，因为肥胖（AHRQ优先疾病）和年龄增长（代表AHRQ优先妇女和老年人人群）增加了DUB和子宫内膜癌的风险。 目标和具体目标-总体目标是通过对各种替代疗法进行比较有效性研究，优化DUB的护理。该研究将特别关注子宫内膜癌作为结局。 具体目标1评估子宫内膜切除术与药物治疗相比是否会增加子宫内膜癌的风险。具体目标2研究了接受消融术与药物治疗的女性患者的癌症诊断是否延迟。最后，具体目标3研究了接受消融术的女性与选择药物治疗并发展为子宫内膜癌的女性相比，是否存在更高的子宫内膜癌手术分期。 研究设计和方法一项回顾性队列研究将在健康改善网络（THIN）中进行，THIN是一个英国病历数据库，有超过60万名诊断为DUB的妇女，她们接受了子宫内膜切除术或药物治疗。本研究将报告未校正结果和针对可能混杂因素校正的结果。它将使用考克斯比例风险模型检查子宫内膜癌的相对风险-它将通过比较治疗组之间从DUB诊断到癌症诊断的中位时间来研究诊断延迟-它将比较治疗组之间I期子宫内膜癌的比例。 研究结果可能会深刻影响DUB的治疗模式和子宫内膜癌的筛查方案。 公共卫生相关性：这项研究将比较子宫内膜切除术与药物治疗的有效性，药物治疗是月经异常出血的最常见原因之一。它旨在通过比较这些治疗组之间的癌症风险，癌症诊断延迟以及每种癌症的严重程度来研究子宫癌（子宫内膜癌）的差异。这将有助于女性就异常月经出血的治疗方案做出明智的决定，并帮助医生为癌症监测和治疗提供适当的指导和建议。