Long-term Follow-up of Sequential Chemotherapy and Stimulation for Fertility Preservation in Young Patients Treated for a Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Assessment of fertility in terms of cumulative incidence of long-term pregnancy
研究概览
简要总结
Interventional research with low risks and constraints, prospective and monocentric on the assessment of long-term fertility in patients who underwent an adjuvant sequential chemotherapy with or without a controled ovarian hyperstimulation. This study follows a previous one called NCT 01614704.
详细描述
The patients will have a follow-up once a year during ten years beginning at the end of their chemotherapy.
They will have a consultation in oncology consisting of:
- a clinical exam,
- a collection and follow-up of oncological data
- a collection of ongoing cancer treatments
and a consultation in gynecology consisting of:
- a pelvic ultrasound scan (for AFC: Antral Follicle Count)
- a biological test (FSH, LH, E2, AMH)
- a collection of gynecological data, contraception and reproductive medicine
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients included in the study CT 01614704
- •Informed and written consent
- •Affiliated to the National Social Security System
排除标准
- •Impossibility to submit at the study procedures due to geographic, social or mental reasons
- •Patient deprived of their liberty or under guardianship or tutorship.
研究组 & 干预措施
Study Process
Consultation, Biological Test, Pelvic Ultrasound
干预措施: Consultation (Procedure)
Study Process
Consultation, Biological Test, Pelvic Ultrasound
干预措施: Biological Test (Biological)
Study Process
Consultation, Biological Test, Pelvic Ultrasound
干预措施: Pelvic Ultrasound (Procedure)
结局指标
主要结局
Assessment of fertility in terms of cumulative incidence of long-term pregnancy
时间窗: 10 years after chemotherapy
for patients who underwent adjuvant sequential chemotherapy of anthracycline and taxane separately, depending on whether or not they have had Controlled Ovarian Hyperstimulation
次要结局
- Study the long-term carcinologic safety of Controlled Ovarian Hyperstimulation without Letrozole or Tamoxifen co-treatment in terms of survival without relapse(After chemotherapy ad until disease progression or death regardless of the cause, up to 10 years after chemotherapy)
- Assessment of fertility in terms of cumulative incidence of births(10 years after chemotherapy)
- Assessment of the gonadotoxicity of the adjuvant sequential chemotherapy based on anthracyclines and taxanes - Antral Follicle Count(10 years after chemotherapy)
- Assessment of fertility - number of pegnancies spontaneous versus assisted(10 years after chemotherapy)
- Assessment of fertility - pregnancy outcome : miscarriage or single or multiple birth separately(10 years after chemotherapy)
- Assessment of the number of patient willing to re-exploit their frozen gametes(10 years after chemotherapy)
- Assessment of the gonadotoxicity of the adjuvant sequential chemotherapy based on anthracyclines and taxanes - AMH rate(10 years after chemotherapy)