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

Pediatric Cancer Clinical Trial

— SALTO-BIO  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02665819
• Other study ID #: 1508057
• Secondary ID: 2015-A00667-42
• Status: Completed
• Phase: N/A
• First received: January 25, 2016
• Last updated: February 16, 2018
• Start date: October 23, 2015
• Est. completion date: November 29, 2016

Study information

• Verified date: February 2018
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: November 29, 2016
• Est. primary completion date: November 29, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pediatric Cancer

Intervention

Other:
• Pediatric cancer women survivors
Women will incur a blood taking to obtain fertility indication.

Locations

Country	Name	City	State
France	Chu Grenoble	Grenoble
France	IHOP 1 Lyon	Lyon
France	CH Lyon Sud	Pierre Bénite
France	CHU Saint-Etienne	Saint Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure the FSH hormone rate.	In this arm women will incur a blood taking to measure the FSH hormone rate.	Day 1
Primary	Measure the AMH hormone rate.	In this arm women will incur a blood taking to measure the AMH hormone rate.	Day 1
Primary	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	Quality of life	The quality of life for each patient will be measured with the SF-36 scale.	Day 1
Secondary	Identification of new loci associated to ovarian toxicity	With a pan-genomic method, new loci (associated to ovarian toxicity) will be identified.	Day 1