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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Completed

CT.gov ID

NCT02665819

Collaborator

(none)

101

Enrollment

Locations

13.2

Actual Duration (Months)

25.3

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pediatric Cancer	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 Design

Study Type:

Observational

Actual Enrollment :

101 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

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.

Actual Study Start Date :

Oct 23, 2015

Actual Primary Completion Date :

Nov 29, 2016

Actual Study Completion Date :

Nov 29, 2016

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Measure the FSH hormone rate. [Day 1]
In this arm women will incur a blood taking to measure the FSH hormone rate.
Measure the AMH hormone rate. [Day 1]
In 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 1]
With the blood taking realized for each patient, genetic markers will be obtained to identify their fertility capacity.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Chu Grenoble	Grenoble	France	38000
2	IHOP 1 Lyon	Lyon	France	69000
3	CH Lyon Sud	Pierre Bénite	France	69000
4	CHU Saint-Etienne	Saint Etienne	France	42000

Sponsors and Collaborators

Centre Hospitalier Universitaire de Saint Etienne

Investigators

Principal Investigator: BERGER Claire, MD, CHU SAINT ETIENNE
Study Chair: Léonie CASAGRANDA, PhD, CHU SAINT ETIENNE

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Saint Etienne

ClinicalTrials.gov Identifier:

NCT02665819

Other Study ID Numbers:

1508057
2015-A00667-42

First Posted:

Jan 28, 2016

Last Update Posted:

Feb 20, 2018

Last Verified:

Feb 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Feb 20, 2018