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、多民族的纵向研究，旨在描述更年期过渡期间发生的生理和社会心理变化，并观察其对随后的健康和年龄相关疾病风险因素的影响。最初的RFA的目标是回答以下问题：激素如何随着更年期的过渡而变化？哪些因素会影响转型的时机？更年期有哪些症状，哪些人有风险？心血管危险因素如何随着转变而改变，是否存在种族差异？在过渡时期骨质流失的速率是多少？骨质流失是什么时候开始的，有哪些危险因素？更年期对健康的影响是什么？哪些人有风险？SWAN正在以社区为基础的样本中汇编迄今为止最全面的健康特征以及妇女从绝经前到绝经后的生理和社会心理变化。SWAN现在准备研究这些更年期相关的变化对随后的健康老龄化和生殖后时期与年龄相关的疾病的影响。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）根据RFA AG-94-002《老年妇女的更年期与健康》资助。SWAN的第一个竞争性延续（SWAN II）于1999年获得资助，第二个（SWAN III）于2004年获得资助。SWAN一、二、三期由合作协议机制支持，共有9个资助组成部分：7个临床中心、1个中央生殖激素实验室（CLASS）和1个协调中心。第二个中心实验室（MRL）最初是作为协调中心（CC）的分包合同资助的。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（U01 AG 17719, PI: Dr. MaryFran Sowers）。由于与研究无关的原因，新泽西医学院的现场运作于2004年4月停止。这一行动的依据是两名突然辞职的研究人员提出的指控。SWAN PI和研究协调员随后被免除了这些指控。请参阅附录12以获得更完整的报告。这笔拨款于2005年转移到阿尔伯特·爱因斯坦医学院。从那时起，新泽西州的PI和项目主任就不知疲倦地努力克服障碍，重新实施这项研究。截至2008年6月1日，共有155名妇女成功地完成了门诊检查，并计划再进行5次检查。我们预计，到SWAN III结束时，将可获得250名妇女的数据。这是非常令人鼓舞的，因此，新泽西州SWAN网站的PI Nanette Santoro已被NIA批准准备U01申请，以覆盖西班牙裔妇女的进一步接触。请注意，SWAN iv计划的申请只适用于其余六个地点。有关新泽西站点的信息包含在Nanette Santoro博士提交的单独申请中。从1995-1997年间筛查的16,000多名40-55岁的女性中，3302名42-52岁的女性被纳入SWAN的纵向队列（7个临床中心各约450名）。他们在1996-1997年间完成了基线门诊访问。在3302名女性中，1550名是白种人，935名是非裔美国人，286名西班牙裔，250名中国人，281名日本人。1997年开始的每日激素研究（DHS）纳入了880名月经妇女，该研究旨在检查更年期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.