An Italian Multicenter Prospective Cohort Study on Fertility Preservation and Pregnancy Issues in Young Breast Cancer Patients: PREgnancy and FERtilty (PREFER)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 39
- 主要终点
- Type of anticancer therapies administered during pregnancy
研究概览
简要总结
The PREgnancy and FERtility (PREFER) study is a comprehensive program aiming to optimize care and improve knowledge around the topics of fertility preservation and pregnancy issues in young breast cancer patients. The program was initiated at the National Institute for Cancer Research, IRCCS AOU San Martino - IST in Genova (Liguria Region, Italy) and then it has been spread to other Italian Institutions under the umbrella of the Gruppo Italiano Mammella (GIM) study group. It is composed of two distinctive studies, one assessing fertility (i.e. PREFER-FERTILITY) and the other pregnancy (PREFER-PREGNANCY) issues. Hence, two different study protocols were developed under the umbrella of the PREFER registry.
PREFER-FERTILITY aims to obtain and centralize data about the preferences and choices of young cancer patients on the fertility preservation strategies available in Italy. Furthermore, it aims to assess the outcomes of patients undergoing one or more strategies for fertility preservation in terms of success of the techniques (i.e. recovery of ovarian function, number of cryopreserved oocytes, post-treatment pregnancies) and safety (i.e. long-term survival outcomes).
PREFER-PREGNANCY has two main objectives: 1) to obtain and centralize data on the management of breast cancer diagnosed during pregnancy, the obstetrical and paediatric care of children born after prior in utero exposure to anticancer treatments, and the long-term survival outcomes of these patients; 2) to obtain and centralize data on the clinical outcomes of breast cancer survivors that achieve a pregnancy after prior diagnosis and treatment of breast cancer.
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
- •breast cancer diagnosis
- •age between18 and 45 years (only for PREFER-FERTILITY)
- •have not received any radiation or chemotherapy for cancer before enrolment (only for PREFER-FERTILITY)
- •absence of metastatic disease (only for PREFER-FERTILITY)
- •diagnosis of breast cancer during pregnancy or within 1 year from the end of pregnancy or pregnancy after prior diagnosis and treatment for breast cancer (only for PREFER-PREGNANCY)
- •informed consent
排除标准
- •inability to provide written informed consent
- •stage IV disease at diagnosis (only for PREFER-FERTILITY)
- •serious psychiatric disorders
结局指标
主要结局
Type of anticancer therapies administered during pregnancy
时间窗: 15 years
Assessed through medical records
Rate of patients undergoing the different strategies for fertility preservation
时间窗: 15 years
Assessed through medical records
Type of strategies for fertility preservation proposed by oncologists
时间窗: 15 years
Assessed through medical records
Safety: incidence of adverse events
时间窗: 15 years
Assessed through medical records
Rate of patients interested in the available strategies for fertility preservation
时间窗: 15 years
Assessed through medical records
Overall survival
时间窗: 15 years
Reasons for refusal of the available strategies for fertility preservation
时间窗: 15 years
Assessed through an open questionnaire
Safety: pregnancy complications
时间窗: 15 years
Assessed through medical records
Disease-free survival
时间窗: 15 years
次要结局
- Success of the available strategies for fertility preservation: rate of recovery of ovarian function after antitumor treatments(15 years)
- Serum hormonal changes during chemotherapy and study follow up(15 years)
- Success of the available strategies for fertility preservation: number of oocytes collected and cryopreserved(15 years)
- Obstetrical and paediatric care of children born after prior in utero exposure to anticancer treatments(15 years)
- Success of the available strategies for fertility preservation: number of pregnancies achieved after breast cancer treatments(15 years)
- Obstetrical and paediatric care of children born in breast cancer survivors(15 years)
研究者
Lucia Del Mastro,MD
MD
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy