Clinical trial NCT02665819: Long Term Support for Pediatric Cancer Adult Survivors in Rhône-Alpes : Evaluation of Women Fertility.
Official title: SALTO-BIO (Long Term Follow up in Oncology) - PanCareLIFE. Long Term Support for Pediatric Cancer Survivors in Rhône-Alpes. Evaluation of Women Fertility.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Cancer
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2016-01-28
Enrollment: 101
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population studied belongs to a cohort composed of women treated for a cancer in their childhood (diagnosed between 1987 and 1999 in Rhône-Alpes Region) before 15 years old.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Measure the FSH hormone rate.
timeFrame: Day 1
measure: Measure the AMH hormone rate.
timeFrame: Day 1
measure: Detect the genetic polymorphism of the FSH and AMH hormones.
timeFrame: Day 1
Secondary outcomes:
measure: Quality of life
timeFrame: Day 1
measure: Identification of new loci associated to ovarian toxicity
timeFrame: Day 1
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Chu Grenoble
city: Lyon
country: France
facility: IHOP 1 Lyon
city: Pierre Bénite
country: France
facility: CH Lyon Sud
city: Saint Etienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: BERGER Claire, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU SAINT-ETIENNE
name: Léonie CASAGRANDA, PhD
role: STUDY_CHAIR
References: