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，旨在描述更年期过渡期间发生的生理和心理社会变化，并观察它们对随后的健康和与年龄相关疾病的风险因素的影响。最初的RFA的目标是回答以下问题：荷尔蒙如何随着更年期的转变而变化？影响过渡时机的因素有哪些？伴随着更年期的症状是什么？谁处于危险之中？心血管危险因素如何随过渡而变化，是否存在种族差异？在过渡过程中，骨丢失的速度是多少？骨质流失从什么时候开始？危险因素是什么？更年期的健康后果是什么？谁处于危险之中？斯旺正在编制迄今为止最全面的关于妇女从绝经前到绝经后的健康以及生理和心理社会变化的特征的社区样本。斯旺现在准备研究这些与更年期相关的变化对随后的健康老龄化以及生殖后阶段与年龄相关的疾病的影响。1994年9月，国家老龄研究所(NIA)、国家护理研究所(NINR)和妇女健康研究办公室(ORWH)响应RFA AG-94-002《老年妇女的更年期和健康》，首次为SWAN I提供资金。《天鹅》的第一部续集(《天鹅2》)于1999年获得资金，第二部(《天鹅3》)于2004年获得资金。天鹅一号、二号和三号得到了合作协议机制的支持，由9个资助部分组成：7个临床中心、一个中央生殖激素实验室(班)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)的分包合同提供资金的。此外，在单独资助下(U01 AG 17719，PI：Dr.Maryfran Sowers)于2000年6月建立了一个血清、血浆和尿液样本核心资料库和一个脱氧核糖核酸资料库。由于与研究无关的原因，新泽西医学院的现场作业于2004年4月停止。这一行动的依据是两名Study员工提出的指控，他们突然辞职。随后，天鹅派和研究协调员被免除了这些指控。有关更完整的报告，请参阅附录12。这笔赠款于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和项目总监不知疲倦地工作，克服障碍，重新实施这项研究。截至2008年6月1日，共有155名妇女成功完成了诊所就诊，并计划再就诊5次。我们预计，到天鹅III结束时，将有250名女性的数据可用。这是非常令人鼓舞的，因此，新泽西天鹅网站的Nanette Santoro，Pi已经获得NIA的批准，准备一份U01申请，以涵盖西班牙裔妇女的进一步接触。请注意，天鹅四号项目的申请只涉及其余六个地点。与新泽西州网站相关的信息包含在纳内特·桑托罗博士提交的单独申请中。在1995-1997年间接受筛查的16,000多名年龄在40-55岁之间的妇女中，有3302名年龄在42-52岁的妇女参加了斯旺的纵向队列(7个临床中心各约450名)。他们在1996-1997年间完成了基线诊所访问。在注册的3302名女性中，1550人是高加索人，935人是非裔美国人，286人是西班牙人，250人是中国人，281人是日本人。一组880名经期妇女参加了始于1997年的每日荷尔蒙研究(DHS)，该研究旨在检查更年期过渡期间周期性的每日荷尔蒙和症状模式。

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.