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临床试验/NCT02878434
NCT02878434招募中不适用

Fertility Preservation in Young Women With Cancer: an International Registration Study From the International Network on Cancer, Infertility and Pregnancy (INCIP)

University Hospital, Gasthuisberg2 个研究点 分布在 2 个国家目标入组 2,000 人开始时间: 2017年5月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,000
试验地点
2
主要终点
Fertility Outcome

研究概览

简要总结

The researchers aim to record the incidence, treatment and long term follow up of fertility preserving cancer treatment. Both the oncological and fertility outcome are recorded.

Study population: All patients with a cancer for whom a fertility preserving cancer treatment is applied. The results of the study population are compared to young women undergoing standard cancer treatment.

详细描述

Cancer is the second leading cause of death during the reproductive years. The long term survival improves for most cancers, reaching 80% for pediatric cancer and more than 70% for cancers in adults between 20 and 49 years of age. Early detection and improvements in cancer treatment contribute to these figures. As a result, quality of life of which preservation of fertility is one aspect, becomes more important. Fertility may however be influenced by surgery and by the gonadotoxic effects of chemo and/or radiotherapy. Therefore, fertility sparing treatments are offered to young patients in order to maintain the wish to conceive after cancer treatment. This however is associated with deviation of standard treatment and many different strategies are applied among different centers. In addition, there is a lack of studies investigating the oncological safety of these fertility sparing treatment protocols. The results of this study will enable us to better inform clinicians and patients on the efficacy of fertility sparing cancer treatment.

Objective:

To record the incidence, treatment and long term follow up of fertility preserving cancer treatment. Both the oncological and fertility outcome are recorded.

Study design: International multicentre prospective observational trial

Study population: All patients with a cancer for whom a fertility preserving cancer treatment is applied. The results of the study population are compared to young women undergoing standard cancer treatment.

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
0 Years 至 40 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Young women who want to preserve their fertility during cancer treatment. Patients need to give their signed and written informed consent to participate in the study.

排除标准

  • Mentally disabled or significantly altered mental status that would prohibit the understanding and giving of informed consent

结局指标

主要结局

Fertility Outcome

时间窗: 10 years

pregnancy rate

次要结局

  • Oncological Outcome(5 years)

研究者

发起方
University Hospital, Gasthuisberg
申办方类型
Other
责任方
Principal Investigator
主要研究者

Frederic Amant

MD PhD

University Hospital, Gasthuisberg

研究点 (2)

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