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.

Study Overview

• Status: Completed
• Conditions: Pediatric Cancer
• Intervention / Treatment: Other: Pediatric cancer women survivors

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.

• Study Type: Observational
• Enrollment (Actual): 101

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38000
    • CHU Grenoble
  • Lyon, France, 69000
    • IHOP 1 Lyon
  • Pierre Bénite, France, 69000
    • CH Lyon sud
  • Saint Etienne, France, 42000
    • CHU Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Pediatric cancer women survivors; Women will incur a blood taking to obtain fertility indication.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	The quality of life for each patient will be measured with the SF-36 scale.	Day 1
Identification of new loci associated to ovarian toxicity	With a pan-genomic method, new loci (associated to ovarian toxicity) will be identified.	Day 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: BERGER Claire, MD, CHU Saint Etienne; Study Chair: Léonie CASAGRANDA, PhD, CHU Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2015
• Primary Completion (Actual): November 29, 2016
• Study Completion (Actual): November 29, 2016

Study Registration Dates

• First Submitted: January 25, 2016
• First Submitted That Met QC Criteria: January 25, 2016
• First Posted (Estimate): January 28, 2016

Study Record Updates

• Last Update Posted (Actual): February 20, 2018
• Last Update Submitted That Met QC Criteria: February 16, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 1508057; 2015-A00667-42 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No