Long Term Support for Pediatric Cancer Adult Survivors in Rhône-Alpes : Evaluation of Women Fertility.
- Conditions
- Pediatric Cancer
- Interventions
- Other: Pediatric cancer women survivors
- Registration Number
- NCT02665819
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 101
- 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
- severe mental disorder
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pediatric cancer women survivors 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.
- Primary Outcome Measures
Name Time Method Measure the FSH hormone rate. 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. 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. Day 1 In this arm women will incur a blood taking to measure the AMH hormone rate.
- Secondary Outcome Measures
Name Time Method Quality of life Day 1 The quality of life for each patient will be measured with the SF-36 scale.
Identification of new loci associated to ovarian toxicity Day 1 With a pan-genomic method, new loci (associated to ovarian toxicity) will be identified.
Trial Locations
- Locations (4)
CHU Saint-Etienne
🇫🇷Saint Etienne, France
CH Lyon Sud
🇫🇷Pierre Bénite, France
Chu Grenoble
🇫🇷Grenoble, France
IHOP 1 Lyon
🇫🇷Lyon, France