NCT01008735Unknown不适用
Observational Retrospective Study to Evaluate the Incidence of the Gonadal Toxicity in Women of Reproductive Age With Hodgkin Lymphoma
Gruppo Italiano Studio Linfomi1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2009年7月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- incidence of gonadal toxicity in terms of irreversible amenorrhea and infertility, in women of reproductive age with Hodgkin lymphoma treated with chemotherapy.
研究概览
简要总结
The Gruppo Italiano Studio Linfomi has been collecting data on patients with Hodgkin Lymphoma (HL) since 1988. This archive represents a homogeneous series of consecutive patients with HL. The very long follow up and the availability of clinical and treatment data make it feasible to perform a study on the gonadal toxicity related to treatment for HL.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients in complete remission after chemotherapy for Hodgkin lymphoma
- •Age ≥ 18 e < 40 years
- •Previous regular menstrual cycle
- •No previous or concomitant gynecological diseases affecting reproducing function
- •No other chemo-radiotherapy for other neoplasm
- •Written informed consent
排除标准
- 未提供
结局指标
主要结局
incidence of gonadal toxicity in terms of irreversible amenorrhea and infertility, in women of reproductive age with Hodgkin lymphoma treated with chemotherapy.
时间窗: from end of treatment until date of last contact/visit
次要结局
- role of a prophylactic treatment with oral contraceptives and GnRH analogs in preventing gonadal damage(from end of treatment until date of last contact/visit)
研究者
研究点 (1)
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