Study of Women's Health Across the NationIV: Chicago Site

描述（由申请人提供）：全国妇女健康研究（SWAN）是一项多中心、多种族的纵向研究，旨在描述绝经过渡期间发生的生理和心理变化，并观察其对随后健康和年龄相关疾病风险因素的影响。最初RFA的目标是回答以下问题：激素如何随着绝经过渡而变化？ 哪些因素会影响转型的时机？ 更年期的症状有哪些，谁有风险？ 心血管危险因素如何随着过渡而变化，是否存在种族差异？ 过渡期的骨质流失率是多少？ 骨质流失开始的时间和风险因素是什么？ 更年期的健康后果是什么，谁处于危险之中？SWAN正在汇编迄今为止最全面的社区抽样妇女从绝经前到绝经后的健康及生理和心理变化特征。SWAN现在准备研究这些与更年期有关的变化对随后的健康老龄化和生殖后时期与年龄有关的疾病的影响。SWAN I于1994年9月首次由国家老龄化研究所（NIA），国家护理研究所（NINR）和妇女健康研究办公室（ORWH）资助，以响应RFA AG-94-002，老年妇女的更年期和健康。1999年资助了第一个竞争性继续实施的SWAN（SWAN II），2004年资助了第二个（SWAN III）。SWAN I、II和III得到了合作协议机制的支持，有9个受资助的组成部分：7个临床中心、一个中央生殖激素实验室（CLASS）和一个协调中心。第二个中心实验室（MRL）最初是作为协调中心（CC）的一个实验室提供资金的。此外，2000年6月在单独资助下建立了血清、血浆和尿液标本的核心储存库和DNA储存库（U 01 AG 17719，PI：Dr. MaryFran Sowers）。由于非研究相关原因，新泽西医学院的研究中心运营于2004年4月停止。这一行动的依据是两名突然辞职的研究工作人员提出的指控。SWAN PI和研究协调员随后被免除这些指控。更完整的报告请参见附录12。该补助金于2005年转移到阿尔伯特·爱因斯坦医学院。从那时起，新泽西PI和项目总监不知疲倦地努力克服障碍，重新实施研究。截至2008年6月1日，共有155名妇女成功地完成了门诊，并计划再进行5次门诊。我们预计，到SWAN III结束时，将有250名妇女的数据可用。这是非常令人鼓舞的，因此，NIA已批准新泽西SWAN研究中心的PI Nanette Santoro准备U 01申请，以涵盖西班牙裔女性的进一步接触。请注意，SWAN IV项目申请仅适用于其余六个站点。Nanette Santoro博士提交的单独申请中涵盖了与新泽西研究中心相关的信息。从1995-1997年筛选的16，000多名40-55岁的妇女中，3302名42-52岁的妇女被纳入SWAN的纵向队列（7个临床中心各约450名）。他们在1996-1997年期间完成了基线门诊访视。在入组的3302名女性中，1550名为白人，935名为非洲裔美国人，286名为西班牙裔，250名为中国人，281名为日本人。880名绝经期妇女参加了1997年开始的每日激素研究（DHS），该研究旨在检查绝经过渡期间的周期性每日激素和症状模式。

DESCRIPTION (provided by applicant): The Study of Women's Health Across the Nation (SWAN) is a multi-center, multi-ethnic longitudinal study designed to characterize the physiological and psychosocial changes that occur during the menopausal transition and to observe their effects on subsequent health and risk factors for age-related diseases. The goals of the original RFA were to answer the following questions: How do hormones change with the menopausal transition? What factors affect the timing of the transition? What are the symptoms that accompany menopause and who is at risk? How do cardiovascular risk factors change with the transition and is there ethnic variation? What are the rates of bone loss with the transition? When does bone loss begin and what are the risk factors? What are the health consequences of menopause and who is at risk? SWAN is compiling the most comprehensive characterization to date of the health and the physiologic and psychosocial changes of women from pre- to postmenopause in community based samples. SWAN is now poised to study the effects of these menopause-related changes on subsequent healthy aging and on age-related diseases in the post-reproductive period. SWAN I was first funded in September 1994 by the National Institute on Aging (NIA), the National Institute of Nursing Research (NINR), and the Office of Research on Women's Health (ORWH) in response to RFA AG-94-002, Menopause and Health in Aging Women. The first competing continuation of SWAN (SWAN II) was funded in 1999 and the second (SWAN III) in 2004. SWAN I, II and III have been supported by a cooperative agreement mechanism, with 9 funded components: 7 clinical centers, a central reproductive hormone laboratory (CLASS), and a coordinating center. A second central laboratory (MRL) was originally funded as a subcontract to the Coordinating Center (CC). In addition, a Core Repository of serum, plasma, and urine specimens and a DNA Repository were established in June 2000 under separate funding (U01 AG 17719, PI: Dr. MaryFran Sowers). For non-study-related reasons, site operations at New Jersey Medical School stopped in April 2004. The basis of this action was allegations made by two study employees who resigned abruptly. The SWAN PI and study coordinator were subsequently exonerated from these allegations. Please see Appendix 12 for a more complete report. The grant was transferred to the Albert Einstein College of Medicine in 2005. Since that time, the New Jersey PI and project director have worked tirelessly to overcome the obstacles to re-implement the study. As of June 1, 2008, a total of 155 women have successfully completed their clinic visit and five more visits are scheduled. We project that by the end of SWAN III, data will be available for 250 women. This has been very encouraging and thus Nanette Santoro, PI of the New Jersey SWAN site has been approved by the NIA to prepare a U01 application to cover further contacts for the Hispanic women. Please note that the SWAN IVproject applications pertain to the remaining six sites only. Information relative to the New Jersey site is covered in the separate application submitted by Dr. Nanette Santoro. From over 16,000 women aged 40-55 years who were screened during 1995-1997, 3302 women aged 42-52 years were enrolled in SWAN's longitudinal cohort (approximately 450 at each of 7 clinical centers). They completed their baseline clinic visit during 1996-1997. Of the 3302 women enrolled, 1550 were Caucasian, 935 African American, 286 Hispanic, 250 Chinese, and 281 Japanese. A subset of 880 menstruating women was enrolled in the Daily Hormone Study (DHS) started in 1997, which is designed to examine cyclical daily hormone and symptom patterns during the menopausal transition.