NCT02665819

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 23, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 28, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2016

Completed
Last Updated

February 20, 2018

Status Verified

February 1, 2018

Enrollment Period

1.1 years

First QC Date

January 25, 2016

Last Update Submit

February 16, 2018

Conditions

Pediatric Cancer

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Quality of life

    Day 1

  • Identification of new loci associated to ovarian toxicity

    Day 1

Study Arms (1)

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

Interventions

Pediatric cancer women survivorsOTHER

Women will incur a blood taking to obtain fertility indication.

Pediatric cancer women survivors

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • \- severe mental disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Chu Grenoble

Grenoble, 38000, France

Location

IHOP 1 Lyon

Lyon, 69000, France

Location

CH Lyon Sud

Pierre-Bénite, 69000, France

Location

CHU Saint-Etienne

Saint-Etienne, 42000, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

25 ml of blood for each patient will be necessary to measure the AMH and FSH hormones rates.

MeSH Terms

Conditions

Neoplasms

Study Officials

  • BERGER Claire, MD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

  • Léonie CASAGRANDA, PhD

    CHU SAINT-ETIENNE

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2016

First Posted

January 28, 2016

Study Start

October 23, 2015

Primary Completion

November 29, 2016

Study Completion

November 29, 2016

Last Updated

February 20, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(4)