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临床试验/NCT01384526
NCT01384526已完成不适用

Investigating the Impact of Tamoxifen Therapy on Ovarian Aging

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 266 人开始时间: 2011年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
266
试验地点
1
主要终点
age of menopause onset

研究概览

简要总结

Ovarian toxicity is a well-described side effect of traditional chemotherapy in premenopausal women receiving treatment for early stage breast cancer. However, the impact of long-term endocrine therapy on ovarian function is not established, and to our knowledge, has never been directly studied. Understanding the effects of hormone therapy on ovarian aging will help breast cancer patients of reproductive age make more informed and empowered decisions regarding their treatment. The purpose of this study is to explore the relationship between tamoxifen therapy and ovarian aging. Patients will be identified through the UCSF Cancer Registry and California Pacific Medical Center Cancer Registry and will be evaluated based on age and menopausal status. Women who read about the study from clinicaltrials.gov and contact the study coordinator will also be considered for enrollment. The age of menopause onset will be assessed through surveys and will be compared to the accepted national average age of natural menopause. Biomarkers of ovarian reserve will be assessed in premenopausal women between ages 25-45 and will be compared to those of healthy age- and ethnicity-matched premenopausal controls from an ongoing RO1- funded prospective longitudinal ovarian aging (OVA) study.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
25 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

age of menopause onset

时间窗: assessed at time of reproductive history survey (30 minutes long, one-time assessment)

The primary aim of this study is to determine the mean age of menopause onset in a cohort of women who have completed a course of tamoxifen therapy and to compare this age with the accepted national average age of natural menopause. Age of menopause onset which is defined as the year of the last menstrual period minus patient's birth year.

次要结局

  • reproductive history(assessed at time of reproductive history survey (30 minutes long, one-time assessment))
  • lifestyle factors, medical history, and demographics(assessed at time of reproductive history survey (30 minutes long, one-time assessment))
  • biomarkers of ovarian reserve(assessed at time of ultrasound and blood draw (single day appointment, 1 hour))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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