LEGACY: A Pilot Study to Establish a Youth Cohort in the Breast CFR

描述（由申请人提供）： 越来越多的流行病学证据表明，早期生活因素可能在乳腺癌的病因学中起重要作用。儿童和青少年可能对与乳腺癌发生或预防乳腺癌有关的暴露特别敏感，因此提供了新的机会窗口，可能在年轻时改变乳腺癌风险。确定可改变的早期生活风险因素对来自乳腺癌家庭的女孩尤为重要，因为考虑到她们的家族史，她们患乳腺癌的风险增加。我们计划建立一个由1,600名6-17岁女孩组成的多中心队列，并对她们进行前瞻性随访，以研究早期暴露（围产期、生活方式和环境暴露），以及遗传和表观遗传因素及其对青春期发育相关终点的影响，包括初潮年龄、乳房发育、乳房组织特征以及性激素和生长激素。该队列名为LEGACY（青年成人癌症流行病学和遗传学课程），将由参加乳腺癌家庭登记处（BCFR）的女孩及其母亲组成，为了进行比较，通过朋友控制确定女孩及其母亲。因此，鉴于其家族史，该队列将增加乳腺癌风险增加的女孩。在准备建立这样一个队列时，我们建议对基线和6个月随访程序进行初步测试，以1）证明队列招募和保留的可行性，2）获得关键终点和暴露变量的患病率和变异性的初步数据。我们将建立在一个小的试点研究，并招募了额外的50名女孩和他们的母亲（30 BCFR女孩和20个朋友对照女孩）从旧金山弗朗西斯科湾区。基线评估包括访谈和自填问卷、人体测量、生物标本样本收集和7天的计步器研究。将在基线评估后6个月重复采集数据和生物样本。从这一试点研究中获得的经验对于整个队列的规划和建立至关重要。 公共卫生相关性： 我们建议对50名6至17岁的女孩及其母亲进行一项试点研究，以证明征聘和保留的可行性。从这项试点研究中获得的经验将有助于建立一个由1,600名女孩组成的队列，并对其进行为期5年的随访，以研究生命早期的暴露及其对青春期发育的影响。

DESCRIPTION (provided by applicant): Epidemiologic evidence is accumulating that early-life factors may play an important role in the etiology of breast cancer. Children and adolescents may be particularly sensitive to exposures that are associated with breast cancer initiation or protection against breast cancer, thus presenting new windows of opportunity to potentially modify breast cancer risk at a young age. Identification of modifiable early-life risk factors is particularly important for girls from breast cancer families as they are at increased risk of developing breast cancer, given their family history. We are planning to establish a multi-center cohort of 1,600 girls aged 6-17 years and follow them prospectively in order to study early-life exposures (perinatal, lifestyle, and environmental exposures), as well as genetic and epigenetic factors and their effects on several endpoints related to pubertal development, including age at menarche, breast development, breast tissue characteristics, and sex and growth hormones. The cohort, named LEGACY (Lessons in Epidemiology and Genetics of Adult Cancer from Youth), will consist of girls and their mothers who are enrolled in the Breast Cancer Family Registry (BCFR) and, for comparison, girls and their mothers identified through friend controls. Thus, the cohort will be enriched with girls at increased breast cancer risk, given their family history. In preparation for establishing such a cohort, we propose to pilot test the baseline and 6-months follow-up procedures in order to 1) demonstrate feasibility of recruitment and retention in the cohort, and 2) obtain preliminary data on prevalence and variability of key endpoint and exposure variables. We will build upon a small pilot study and recruit an additional 50 girls and their mothers (30 BCFR girls and 20 friend control girls) from the San Francisco Bay area. The baseline assessment includes an interview and self-administered questionnaire, anthropometric measurements, collection of biospecimen samples, and a 7-day pedometry study. Data and biospecimen collection will be repeated 6 months after the baseline assessment. Experience gained from this pilot study will be essential for the planning and establishment of the full cohort. PUBLIC HEALTH RELEVANCE: We propose to conduct a pilot study with 50 girls aged 6-17 years and their mothers in order to demonstrate the feasibility of recruitment and retention. Experience gained from this pilot study will help establish a cohort of 1,600 girls that will be followed for 5 years in order to study early-life exposures and their effects on pubertal development.