Long Term Support for Pediatric Cancer Adult Survivors in Rhône-Alpes : Evaluation of Women Fertility. (SALTO-BIO)
SALTO-BIO (Long Term Follow up in Oncology) - PanCareLIFE. Long Term Support for Pediatric Cancer Survivors in Rhône-Alpes. Evaluation of Women Fertility.
PanCareLIFE Study is a cohort study of patients treated for cancer in childhood, and biological case-control study nested in the cohort (WP4) is coordinated by Erasmus MC-Sophia Children's Hospital in Holland.
Ensure optimal patient quality of life throughout his life is a priority for the research teams. PanCareLIFE Study also aims to identify the factors that predispose to impaired quality of life. It is in this light that will be offered to patients a quality of life questionnaires during the period of treatment and then periodically during long-term follow-up.
研究概览
详细说明
PanCareLIFE Study is a cohort study of patients treated for cancer in childhood, and biological case-control study nested in the cohort (WP4) is coordinated by Erasmus MC-Sophia Children's Hospital in Holland. At European level, approximately 1,200 women are expected in this latest study, the patients were already identified through certain regional or national registries in terms of cumulative doses of chemotherapy, surgery, radiation.
Ensure optimal patient quality of life throughout his life is a priority for the research teams. PanCareLIFE Study also aims to identify the factors that predispose to impaired quality of life. It is in this light that will be offered to former patients to complete quality of life questionnaires during the period of treatment and then periodically during long-term follow-up.
The SALTO-BIO study is the French part of the European study PanCareLIFE. CHU of Saint-Etienne as French promotor, will organize this study only on the Rhône-Alpes region (Lyon, Grenoble and Saint-Etienne centers) and will participate as co-investigator and "data provider "to WP2, WP3, WP4 and WP6. Indeed, ototoxicity is already studied by a French group.
研究类型
注册 (实际的)
联系人和位置
学习地点
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-
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Grenoble、法国、38000
- Chu Grenoble
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Lyon、法国、69000
- IHOP 1 Lyon
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Pierre Bénite、法国、69000
- CH Lyon sud
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Saint Etienne、法国、42000
- Chu Saint-Etienne
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- min 18 years old
- female
- diagnosed for a cancer between 01/01/87 and 31/12/99, before 15 years old, and living in Rhône-Alpes
- treated with chemotherapy +/- radiotherapy
- accepting a blood taking to perform DNA and hormonal tests
- affiliated to a security social scheme
- informed consent
Exclusion Criteria:
- severe mental disorder
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Pediatric cancer women survivors
Women diagnosed for a cancer between 01/01/87 and 31/12/99 before the age of 15 years old living in Rhône-Alpes, will incur a blood taking for DNA tests (hormone tests) to see their fertility capacity.
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Women will incur a blood taking to obtain fertility indication.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Measure the FSH hormone rate.
大体时间:Day 1
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In this arm women will incur a blood taking to measure the FSH hormone rate.
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Day 1
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Measure the AMH hormone rate.
大体时间:Day 1
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In this arm women will incur a blood taking to measure the AMH hormone rate.
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Day 1
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Detect the genetic polymorphism of the FSH and AMH hormones.
大体时间:Day 1
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With the blood taking realized for each patient, genetic markers will be obtained to identify their fertility capacity.
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Day 1
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Quality of life
大体时间:Day 1
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The quality of life for each patient will be measured with the SF-36 scale.
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Day 1
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Identification of new loci associated to ovarian toxicity
大体时间:Day 1
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With a pan-genomic method, new loci (associated to ovarian toxicity) will be identified.
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Day 1
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合作者和调查者
调查人员
- 首席研究员:BERGER Claire, MD、CHU Saint Etienne
- 学习椅:Léonie CASAGRANDA, PhD、CHU Saint Etienne
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 1508057
- 2015-A00667-42 (其他标识符:ANSM)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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