Home
Clinical Trials
NCT01620372

French Childhood Cancer Survivor Study

NCT ID: NCT01620372

Last Updated: 2012-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

18000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2031-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The FCCSS is a multicentric national large-scale collaborative population-based study of children treated for a solid tumor before 2000 in France and before the age of 19 years.

The study is concerned by improving knowledge about the long-term effects caused by cancer and its treatments including adverse health and social outcomes.

The main reason of the FCCSS is to estimate the risk of adverse health and social outcomes that may occur after a cancer treatment and to prevent them by providing adapted follow-up care.

The cohort will be followed for up to 20 years from 2011.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The main objectives of the FCCSS are to:

* estimate the relationship between doses received (radiotherapy, chemotherapy) at a given organ and risk of second malignancy tumors;
* help identify patients at higher risk;
* compare the mortality occurred among the survivors with the general population;
* investigate the consequences of various intensities of exposure to chemotherapy and/or radiation on health outcomes (such as cardiovascular, cerebrovascular and thyroid diseases, diabetes,…);
* characterize survivors with respect to socioeconomic status and quality of life.

The cohort will be ascertained using:

* the medical records from the treatment centers in order to characterize the childhood cancer, estimate doses of radiotherapy received by all organs and measure the chemotherapy administered;
* the French National Identification Registry and the French Death Registry in order to obtain the vital status and the causes of the deaths for the former patients
* a self-questionnaire that covers the entire future of the survivors (e.g. social status, family network, fertile offspring, access to care, access to bank loans, occupation,...);
* the French National Health Insurance Information System that contains data on all reimbursements for health expenditure including medicinal products as well as outpatient medical and nursing care, prescribed or performed by healthcare professionals.

In an initial cohort, we have already studied the iatrogenic effects of the cancer treatments. We have estimated the doses of ionising radiations delivered by radiotherapy to the target volume and by organs at distance. We found an important role of the radiotherapy and chemotherapy in the risk of a second cancer:

* the cancers occuring after childhood cancer are in excess compared to the general population,
* we studied the relationship between the brain radiation dose and the cerebrovascular mortality,
* there is a high risk of cardiac pathology after anthracyclines administration for a childhood cancer,
* cancer treatments increase the risk of second malignant neoplasms in digestive organs after a very long latency period,
* the risk of thyroid adenoma increased with the radiation dose received by the thyroid during childhood cancer treatment, and plateaued at high doses,
* there is a high long-term mortality risk for all types of second malignant neoplasms whatever the treatment received.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Childhood Solid Tumor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment cohort (chemo/radiotherapy)

\- those who have survived at least 5 years from the date of diagnosis

No interventions assigned to this group

Self-questionnaire cohort

\- those with a complete address, who come of age, are still alive and sent back a signed consent agreement

No interventions assigned to this group

Medical Insurance cohort

\- those who come of age and authorize the access to the medical facilities of the French Health Insurance Information System

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* All types of solid childhood cancer in France
* Age at diagnosis: Below age 19
* Period of diagnosis: between 1st January 1942 and 31st December 1999
* Complete identification (first name, last name, date of birth and place of birth)

Exclusion Criteria

* Leukaemia cases

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Florent F. de Vathaire, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Institut National de la Santé Et de la Recherche Médicale, France

Locations

Explore where the study is taking place and check the recruitment status at each participating site.