Predictors of Ovarian Insufficiency Through Serial Exams in Young Breast Cancer Patients (POISE Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 232
- 试验地点
- 2
- 主要终点
- Number of Participant Ovarian Insufficiency (Without of Menses for 12 Months) After Breast Cancer Diagnosis
研究概览
简要总结
More than two million American women are breast cancer survivors. Approximately one-third of these women are premenopausal at diagnosis and face issues related to reproduction as they undergo cancer treatment. Ovarian function after breast cancer diagnosis has implications on breast cancer prognosis, choice of adjuvant therapy and reproductive issues such as desire for fertility or concerns about menopause. Therefore, tools to accurately predict ovarian function in breast cancer survivors could significantly impact physicians and patients in counseling, medical and surgical treatment choices, and consideration of fertility preservation options.
The goal of this proposal is to identify pre-chemotherapy hormonal, genetic and ovarian imaging markers that can predict ovarian failure and characterize the course of ovarian function after chemotherapy. The investigators plan to follow a group of young women from breast cancer diagnosis to five years after chemotherapy. The investigators will study the following risk factors: blood hormone levels that reflect ovarian function, genetic mutations that affect how individuals metabolize chemotherapy, and ovarian size and egg count by MRI and ultrasound. The investigators hypothesize that these biomarkers are related to risk of ovarian insufficiency singly. After examining these individual risk factors for ovarian failure, the investigators will put them together into an Ovarian Failure Clinical Predictive Index. This index will be a tool similar to the Gail Model that can be used to determine individual risk for ovarian failure. This tool would assist young breast cancer patients and their physicians in making treatment decisions that would impact cancer survival and reproduction.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •New diagnosis of breast cancer (Stages 0-III)
- •Age <=45
- •Premenopausal (at least one menses over past year)
- •Has a uterus and at least one ovary
排除标准
- •Prior chemotherapy
结局指标
主要结局
Number of Participant Ovarian Insufficiency (Without of Menses for 12 Months) After Breast Cancer Diagnosis
时间窗: Years 1-5
Number of participant without of menses for 12 months after breast cancer diagnosis
次要结局
- Number of Participants Who Experience Return of Menses After 3 Months of Amenorrhea(Years 1-5)
研究者
Hui-Chun Irene Su
Professor of Obstetrics, Gynecology, and Reproductive Sciences
University of California, San Diego
