The FIRSTT Trial: Assessing Outcomes of Minimally Invasive Leiomyoma Therapies

FIRSTT 试验：评估微创平滑肌瘤治疗的结果

• 批准号: 8311027
• 负责人: Elizabeth A Stewart
• 金额: $ 58.1万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-08-01 至 2015-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8311027
• 关键词: Absenteeism; Accounting; Address; Adverse effects; Adverse event; Alternative Therapies; Arteries; Biological Assay; Clinic; Coagulative necrosis; Complementary therapies; Cost Effectiveness Analysis; Diagnosis; Direct Costs; Disease; Economics; FDA approved; Facilities and Administrative Costs; Fibroid Tumor; Focused Ultrasound Therapy; Follicle Stimulating Hormone; Goals; Health; Health Care Costs; Health Status; Hemorrhage; Hysterectomy; Impairment; Individual; Intervention; Lead; Leiomyoma; Life; Location; Magnetic Resonance Imaging; Medical; Menopause; Morbidity - disease rate; Myoma; Necrosis; Operative Surgical Procedures; Outcome; Outcome Study; Ovarian; Pain; Periodicity; Pregnancy; Prevalence; Protocols documentation; Quality of life; Randomized Clinical Trials; Recruitment Activity; Reporting; Resources; SF-36; Safety; Serum; Symptoms; Techniques; Treatment Cost; Universities; Uterine Fibroids; Uterine myomectomy; Woman; Work; clinically significant; cohort; cost; disability; improved; minimally invasive; mullerian-inhibiting hormone; myometrium; primary outcome; symptomatic improvement

DESCRIPTION (provided by applicant): Uterine leiomyomas (fibroids or myomas) are diagnosed in one-fourth of all women and up to 75 % of black women. The direct health care costs attributable to leiomyomas exceed $2.1 billion annually. However, our work and that of others, report that indirect costs (disability and absenteeism) are a large part of total costs for women with uterine fibroids. Addressing the symptoms of clinically significant uterine fibroids and controlling health care costs from a societal perspective are both important goals. Despite the prevalence and morbidity of this disease and the significant costs of treatment, there is a dearth of evidence to guide therapy. Two minimally-invasive FDA-approved techniques treat leiomyomas in a wide variety of sizes and locations: uterine artery embolization (UAE) and MRI-guided focused ultrasound surgery (MRgFUS). However, they differ significantly in approach, mechanism of action and side effects and they have never been directly compared. We therefore propose the FIRSTT trial: Fibroid Interventions: Reducing Symptoms Today and Tomorrow), a randomized clinical trial treating 220 women with symptomatic uterine leiomyomas with UAE or MRgFUS and following them for three years. A racially diverse cohort of subjects will be achieved by recruiting through Mayo Clinic Rochester and Duke University. This trial is powered to compare short- and long-term outcomes, adverse events, predictors of outcome, and costs of each treatment. The specific aims of this project are: 1) To report comprehensive outcomes and predictors of outcome following UAE and MRgFUS. 2) To quantitate and compare the ovarian impairment following UAE and MRgFUS. 3) To produce an economic analysis of UAE and MRgFUS treatment from a U.S. societal perspective. PUBLIC HEALTH RELEVANCE: Uterine leiomyomas or fibroids are found in one-fourth of all women and up to three-fourths of black women. Fibroids are the leading cause of hysterectomy and account for health care costs over $2.1 billion annually. This study proposes to study the outcomes and limitations of two widely used alternatives to hysterectomy for fibroids: uterine artery embolization (UAE) and magnetic resonance imaging guided focused ultrasound surgery (MRgFUS).

描述（由申请人提供）：子宫平滑肌瘤（肌瘤或肌瘤）被诊断为四分之一的所有妇女和高达75%的黑人妇女。平滑肌瘤的直接保健费用每年超过21亿美元。然而，我们和其他人的工作报告说，间接费用（残疾和缺勤）是子宫肌瘤妇女总费用的很大一部分。从社会角度解决临床上显著的子宫肌瘤的症状和控制医疗保健费用都是重要的目标。 尽管这种疾病的患病率和发病率以及治疗的巨大成本，但缺乏指导治疗的证据。两种经FDA批准的微创技术治疗各种大小和位置的平滑肌瘤：子宫动脉栓塞术（UAE）和MRI引导的聚焦超声手术（MRgFUS）。然而，它们在方法、作用机制和副作用方面存在显着差异，并且从未进行过直接比较。 因此，我们提出了FIRSTT试验：肌瘤干预：减少症状的今天和明天），一项随机临床试验，治疗220名妇女与UAE或MRgFUS症状子宫平滑肌瘤，并遵循他们三年。将通过马约诊所罗切斯特和杜克大学招募受试者，以实现受试者的种族多样化队列。本试验有能力比较短期和长期结局、不良事件、结局预测因素和每种治疗的成本。 该项目的具体目标是：1）报告UAE和MRgFUS后的综合结局和结局预测因素。 2)比较UAE和MRgFUS对卵巢功能的影响。 3)从美国社会的角度对UAE和MRgFUS治疗进行经济分析。 公共卫生相关性：四分之一的女性和高达四分之三的黑人女性发现子宫平滑肌瘤或子宫肌瘤。子宫肌瘤是子宫切除术的主要原因，每年的医疗费用超过21亿美元。本研究旨在研究子宫肌瘤子宫切除术的两种广泛使用的替代方法的结局和局限性：子宫动脉栓塞术（UAE）和磁共振成像引导的聚焦超声手术（MRgFUS）。