Constitution d'Une Cohorte Nationale rétrospective de Survivants d'un Cancer Solide de l'Enfant diagnostiqué Avant 2000
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.
Observational
Observational Model: Cohort, Time Perspective: Retrospective
All health events of interest
all causes mortality (e.g. cerebrovascular, cardiovascular,...) all iatrogenic events (e.g. diabetes, thyroid adenomas, cardiac diseases, second malignant solid tumors, secondary leukemia,...)
by time since diagnosis of solid childhood cancer
No
Florent F. de Vathaire, Ph.D.
Principal Investigator
Institut National de la Santé Et de la Recherche Médicale, France
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
C12-25
NCT01620372
November 2011
November 2031
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