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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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-
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Grenoble, Frankrike, 38000
- Chu Grenoble
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Lyon, Frankrike, 69000
- IHOP 1 Lyon
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Pierre Bénite, Frankrike, 69000
- CH Lyon sud
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Saint Etienne, Frankrike, 42000
- Chu Saint-Etienne
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
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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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Measure the FSH hormone rate.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Quality of life
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Utredare
- Huvudutredare: BERGER Claire, MD, CHU Saint Etienne
- Studiestol: Léonie CASAGRANDA, PhD, CHU Saint Etienne
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 1508057
- 2015-A00667-42 (Annan identifierare: ANSM)
Plan för individuella deltagardata (IPD)
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