The CYGNET Study: Enviromental and Genetic Determinants of Maturation of Girls

描述（由申请人提供）：CYGNET研究（年轻女孩营养、环境和过渡的队列研究）是一项前瞻性队列研究，共有444名女孩参加，旨在研究青春期早期发育和其他成熟标志中的环境、生活方式和遗传因素。受试者在2005年6月至2006年8月入组时年龄为6-8岁，研究人员目前正在进行第5个年度（第4次随访）检查周期。研究的基本原理在于人们越来越认识到青春期转变可能是确定乳腺癌长期风险的重要易感窗口。对具有生殖活性的化学品的潜在接触引起了人们的关注，即这些接触以及其他生活方式和遗传因素可能在改变青春期开始年龄和性成熟的其他标志方面发挥重要作用。 因此，这项队列研究的重点是确定与性成熟中各种里程碑相关的因素。一个关键的焦点是乳房发育，在年度临床检查中通过坦纳阶段进行评估。 随着他们继续跟踪研究参与者，可能与乳腺癌风险相关的其他参数也引起了人们的兴趣，包括月经的开始，周期规律的建立，克里思（从青春期开始到月经开始的时间），高峰身高速度和达到成年身高。通过临床检查（例如，人体测量学），访谈和问卷调查（例如，个人护理产品的使用、身体活动、食物摄入、心理社会因素），以及收集和分析环境和遗传因素的生物样本（尿液、血液、唾液）。 通过与社区合作伙伴的密切整合，促进了与研究参与者和更广泛社区的互动，社区合作伙伴也参与了研究方案的各个方面。 在第四个年度检查周期中，研究人员从444名女孩的原始队列中收集了391名（88%）的数据。 在第1年随访后，他们每年保留超过97%的队列。假设每年的保留率相似，他们估计，在2013-2014年的第九个考试周期，当女孩年龄在14-16岁时，我们将看到大约339名女孩。到那时，我们预计所有的女孩都将开始青春期，大多数将经历身高增长的高峰和初潮的开始，少数将达到成年身高。使用保守假设，研究者应该有足够的把握度来检测大多数主要终点的相关性，约为1.57，比较连续变量（如生物标志物水平）的高低四分位数。研究人员预计将继续与辛辛那提和纽约的类似研究合作。

DESCRIPTION (provided by applicant): The CYGNET Study (Cohort study of Young Girls' Nutrition, Environment, and Transitions) is a prospective cohort study of 444 girls that is examining environmental, lifestyle, and genetic factors in the development of early puberty and other hallmarks of maturation. Participants were aged 6-8 years at the time of enrollment from June 2005 to August 2006, and the investigators are currently in their 5th annual (4th follow-up) exam cycle. The study rationale lies in the growing recognition that the pubertal transition may be an important window of susceptibility in establishing long-term risk of breast cancer. The potential exposures to chemicals that are hormonally active raise concerns that these exposures and other lifestyle and genetic factors may play important roles in modifying age-at-onset of puberty and other hallmarks of sexual maturation. This cohort study is thus focused on determining factors that are associated with various milestones in sexual maturation. A key focus has been on breast development, as assessed by Tanner stage at annual clinical exams. As they continue to follow study participants, other parameters that may be associated with breast cancer risk are of interest, including onset of menses, establishment of cycle regularity, tempo (the time from onset of puberty to onset of menses), peak height velocity, and attainment of adult height. Exposures of interest are assessed through clinical exam (e.g., anthropometry), interviews and questionnaires (e.g., personal care product use, physical activity, food intake, psychosocial factors), and collection and assay of biospecimens (urine, blood, saliva) for environmental and genetic factors. Interactions with study participants and the broader community are facilitated by close integration with community partners, who are also involved in all aspects of study protocol. Through the 4th annual exam cycle, the investigators collected data from 391 (88%) of the original cohort of 444 girls. After the 1st follow-up year, they have retained annually over 97% of the cohort. Assuming similar annual retention rates, they estimate that for the ninth exam cycle in 2013-2014 when girls are 14-16 years old, we will see approximately 339 girls. By then, we expect that all girls will have begun puberty, most will have experienced peak height velocity and onset of menarche, and a small number will have achieved their adult height. Using conservative assumptions, the investigators should have adequate power to detect associations for most major endpoints of about 1.57 comparing high and low quartiles of a continuous variable such as biomarker levels. The investigators anticipate continuing our collaborations with similar studies in Cincinnati and New York.