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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Grenoble, Frankreich, 38000
- CHU Grenoble
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Lyon, Frankreich, 69000
- IHOP 1 Lyon
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Pierre Bénite, Frankreich, 69000
- CH Lyon Sud
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Saint Etienne, Frankreich, 42000
- CHU Saint-Etienne
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Measure the FSH hormone rate.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Quality of life
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: BERGER Claire, MD, CHU Saint Etienne
- Studienstuhl: Léonie CASAGRANDA, PhD, CHU Saint Etienne
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- 1508057
- 2015-A00667-42 (Andere Kennung: ANSM)
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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