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Long Term Support for Pediatric Cancer Adult Survivors in Rhône-Alpes : Evaluation of Women Fertility.

SALTO-BIO (Long Term Follow up in Oncology) - PanCareLIFE. Long Term Support for Pediatric Cancer Survivors in Rhône-Alpes. Evaluation of Women Fertility.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02665819
Acronym
SALTO-BIO
Enrollment
101
Registered
2016-01-28
Start date
2015-10-23
Completion date
2016-11-29
Last updated
2018-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Cancer

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.

Interventions

OTHERPediatric cancer women survivors

Women will incur a blood taking to obtain fertility indication.

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Quality of lifeDay 1The quality of life for each patient will be measured with the SF-36 scale.
Identification of new loci associated to ovarian toxicityDay 1With a pan-genomic method, new loci (associated to ovarian toxicity) will be identified.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026