French Childhood Cancer Survivor Study (FCCSS)
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|ClinicalTrials.gov Identifier: NCT01620372|
Recruitment Status : Recruiting
First Posted : June 15, 2012
Last Update Posted : October 10, 2012
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.
|Condition or disease|
|Childhood Solid Tumor|
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.
|Study Type :||Observational|
|Estimated Enrollment :||18000 participants|
|Official Title:||Constitution d'Une Cohorte Nationale rétrospective de Survivants d'un Cancer Solide de l'Enfant diagnostiqué Avant 2000|
|Study Start Date :||November 2011|
|Estimated Study Completion Date :||November 2031|
Treatment cohort (chemo/radiotherapy)
- those who have survived at least 5 years from the date of diagnosis
- those with a complete address, who come of age, are still alive and sent back a signed consent agreement
Medical Insurance cohort
- those who come of age and authorize the access to the medical facilities of the French Health Insurance Information System
- All health events of interest [ Time Frame: by time since diagnosis of solid childhood cancer ]
- all causes mortality (e.g. cerebrovascular, cardiovascular,...)
- all iatrogenic events (e.g. diabetes, thyroid adenomas, cardiac diseases, second malignant solid tumors, secondary leukemia,...)
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01620372
|Contact: Florent F. de Vathaire, Ph.Dfirstname.lastname@example.org|
|Principal Investigator:||Florent F. de Vathaire, Ph.D.||Institut National de la Santé Et de la Recherche Médicale, France|