SALTO-BIO (Long Term Follow up in Oncology) - PanCareLIFE. Long Term Support for Pediatric Cancer Survivors in Rhône-Alpes. Evaluation of Women Fertility.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 4
- 主要终点
- Measure the FSH hormone rate.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •min 18 years old
- •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
排除标准
- •severe mental disorder
结局指标
主要结局
Measure the FSH hormone rate.
时间窗: Day 1
In this arm women will incur a blood taking to measure the FSH hormone rate.
Detect the genetic polymorphism of the FSH and AMH hormones.
时间窗: Day 1
With the blood taking realized for each patient, genetic markers will be obtained to identify their fertility capacity.
Measure the AMH hormone rate.
时间窗: Day 1
In this arm women will incur a blood taking to measure the AMH hormone rate.
次要结局
- Quality of life(Day 1)
- Identification of new loci associated to ovarian toxicity(Day 1)