ELLAS Environment, Leiomyomas, Latinas and Adiposity Study

ELLAS 环境、平滑肌瘤、拉丁裔和肥胖研究

• 批准号: 9395499
• 负责人: Erica E Marsh
• 金额: $ 67.33万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-28 至 2022-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9395499
• 关键词: ELLAS; Environment; Leiomyomas; Latinas; Adiposity

 DESCRIPTION (provided by applicant): This proposal, titled ELLAS: Environment, Leiomyomas, Latinas, and Adipocity Study (ELLAS), seeks to address the significant gap in our knowledge of leiomyomas in the fastest growing group of women in the United States-Latinas. Uterine leiomyomas or "fibroids" are well-defined, benign smooth muscle tumors of the uterus that represent a significant healthcare burden in women. For the populations on which we have data, largely Caucasian and African-American women, fibroids are present in 30%-50% of reproductive-age women and have an overall cumulative incidence of >70% by the age of 50 years. Fibroids are associated with menorrhagia, anemia, infertility, pelvic pain, and recurrent pregnancy loss. The physiological and psychological sequelae of these symptoms, and the lack of effective medical treatment options, explain why these benign tumors remain the leading cause of hysterectomy in the United States. Recent analyses estimate the cost of fibroids in the U.S. to be as high as $34 billion annually. While we know that fibroids disproportionately affect African-American women, there are very few data on either their prevalence amongst Latinas or whether there are risk factors for fibroids that are unique to Latinas. The Latina population has high rates of obesity and diabetes, both of which have been implicated as risk factors for fibroids. The overall objective of this proposal is to determine the prevalence and growth patterns of leiomyomas amongst Latinas and to examine metabolic dysregulation as a risk factor for leiomyomas in this population. We will recruit 600 premenopausal Latinas between the ages of 25- 45 for evaluation. Pelvic ultrasound will be performed to determine prevalence and survey data, saliva, and blood samples will be collected (Aim 1). Subjects who have fibroids at this initial visit will return for a follow-up visit in 18-24 months to determine fibroid growth ovr that time and to identify factors related to growth (Aim 1). We will also measure adiposity and various biomarkers of metabolism and glucose regulation, and determine their association with fibroid prevalence and growth (Aims 2 and 3). The results of our study will be clinically significant as we currently have limited data for counseling Latinas on the natural history of the disease or its associated risk factors. Our study design is innovative in that pelvic ultrasounds will be performed on all subjects to identify all fibroids present, not just symptomatic fibroids. Furthermore, the follow-up visit will allow us to collect critical growth data on all tumors. Our prospective longitudinal cohort study will be the first to determine whether obesity and/or glucose dysregulation are associated with ultrasound-confirmed fibroid prevalence, and growth in any population and will thus be of benefit to all women. This study presents an ideal opportunity to conduct a novel prospective analysis on an understudied population and generate data needed to counsel Hispanic women about leiomyomas in an evidence-based way.

 描述（由申请人提供）：该提案名为ELLAS：环境，平滑肌瘤，拉丁美洲和肥胖研究（ELLAS），旨在解决我们在美国增长最快的女性群体中平滑肌瘤知识的重大差距-拉丁美洲。子宫平滑肌瘤或“肌瘤”是子宫的明确定义的良性平滑肌肿瘤，其代表女性的显著医疗负担。对于我们有数据的人群，主要是白人和非洲裔美国妇女，肌瘤存在于30%-50%的育龄妇女中，到50岁时总累积发病率>70%。子宫肌瘤与月经过多、贫血、不孕、盆腔疼痛和反复流产有关。这些症状的生理和心理后遗症，以及缺乏有效的医学治疗方案，解释了为什么这些良性肿瘤仍然是美国子宫切除术的主要原因。最近的分析估计，在美国，肌瘤的成本每年高达340亿美元。虽然我们知道肌瘤不成比例地影响非洲裔美国妇女，但关于其在拉丁美洲人中的患病率或是否存在拉丁美洲人特有的肌瘤风险因素的数据很少。拉丁裔人口肥胖和糖尿病的发病率很高，这两者都被认为是肌瘤的危险因素。本提案的总体目标是确定拉丁美洲人中平滑肌瘤的患病率和生长模式，并检查代谢失调作为该人群中平滑肌瘤的危险因素。我们将招募600名年龄在25- 45岁之间的绝经前拉丁妇女进行评估。将进行盆腔超声检查以确定患病率，并收集调查数据、唾液和血液样本（目标1）。在首次访视时患有肌瘤的受试者将在18-24个月后返回进行随访访视，以确定当时的肌瘤生长情况，并确定与生长相关的因素（目标1）。我们还将测量肥胖和代谢和葡萄糖调节的各种生物标志物，并确定它们与纤维瘤患病率和生长的相关性（目的2和3）。我们的研究结果将具有临床意义，因为我们目前对拉丁美洲人进行疾病自然史或相关风险因素咨询的数据有限。我们的研究设计是创新的，因为将对所有受试者进行盆腔超声检查，以识别所有存在的肌瘤，而不仅仅是症状性肌瘤。此外，随访将使我们能够收集所有肿瘤的关键生长数据。我们的前瞻性纵向队列研究将是第一个确定肥胖和/或血糖失调是否与超声证实的子宫肌瘤患病率相关的研究，以及任何人群的生长，因此将对所有女性有益。这项研究提供了一个理想的机会，进行一个新的前瞻性分析研究不足的人口，并产生所需的数据，以咨询西班牙裔妇女平滑肌瘤的循证方式。