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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

地位

完全的

条件

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

观察性的

注册 (实际的)

101

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Grenoble、法国、38000
        • Chu Grenoble
      • Lyon、法国、69000
        • IHOP 1 Lyon
      • Pierre Bénite、法国、69000
        • CH Lyon sud
      • Saint Etienne、法国、42000
        • Chu Saint-Etienne

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

取样方法

概率样本

研究人群

The population studied belongs to a cohort composed of women treated for a cancer in their childhood (diagnosed between 1987 and 1999 in Rhône-Alpes Region) before 15 years old.

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
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.
Women will incur a blood taking to obtain fertility indication.

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
Measure the FSH hormone rate.
大体时间:Day 1
In this arm women will incur a blood taking to measure the FSH hormone rate.
Day 1
Measure the AMH hormone rate.
大体时间:Day 1
In this arm women will incur a blood taking to measure the AMH hormone rate.
Day 1
Detect the genetic polymorphism of the FSH and AMH hormones.
大体时间:Day 1
With the blood taking realized for each patient, genetic markers will be obtained to identify their fertility capacity.
Day 1

次要结果测量

结果测量
措施说明
大体时间
Quality of life
大体时间:Day 1
The quality of life for each patient will be measured with the SF-36 scale.
Day 1
Identification of new loci associated to ovarian toxicity
大体时间:Day 1
With a pan-genomic method, new loci (associated to ovarian toxicity) will be identified.
Day 1

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

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

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2015年10月23日

初级完成 (实际的)

2016年11月29日

研究完成 (实际的)

2016年11月29日

研究注册日期

首次提交

2016年1月25日

首先提交符合 QC 标准的

2016年1月25日

首次发布 (估计)

2016年1月28日

研究记录更新

最后更新发布 (实际的)

2018年2月20日

上次提交的符合 QC 标准的更新

2018年2月16日

最后验证

2018年2月1日

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)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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