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Completed

NCT Number: NCT02665819

Long Term Support for Pediatric Cancer Adult 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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Chu Grenoble, Grenoble, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pediatric cancer women survivors

Other

Women will incur a blood taking to obtain fertility indication.

Primary outcomes

  1. Measure the FSH hormone rate.

    Time frame: Day 1

    In this arm women will incur a blood taking to measure the FSH hormone rate.

  2. Measure the AMH hormone rate.

    Time frame: Day 1

    In this arm women will incur a blood taking to measure the AMH hormone rate.

  3. Detect the genetic polymorphism of the FSH and AMH hormones.

    Time frame: Day 1

    With the blood taking realized for each patient, genetic markers will be obtained to identify their fertility capacity.

Secondary outcomes

  1. Quality of life

    Time frame: Day 1

    The quality of life for each patient will be measured with the SF-36 scale.

  2. Identification of new loci associated to ovarian toxicity

    Time frame: Day 1

    With a pan-genomic method, new loci (associated to ovarian toxicity) will be identified.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

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

Acronym: SALTO-BIO

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 28, 2016
Registry last updated
Feb 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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