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Constitution d'Une Cohorte Nationale rétrospective de Survivants d'un Cancer Solide de l'Enfant diagnostiqué Avant 2000

18 Years
Open (Enrolling)
Childhood Solid Tumor

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Trial Information

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,

- 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

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

- we studied the relationship between the brain radiation dose and the cerebrovascular

- 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.

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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Retrospective

Outcome Measure:

All health events of interest

Outcome Description:

all causes mortality (e.g. cerebrovascular, cardiovascular,...) all iatrogenic events (e.g. diabetes, thyroid adenomas, cardiac diseases, second malignant solid tumors, secondary leukemia,...)

Outcome Time Frame:

by time since diagnosis of solid childhood cancer

Safety Issue:


Principal Investigator

Florent F. de Vathaire, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Study ID:




Start Date:

November 2011

Completion Date:

November 2031

Related Keywords:

  • Childhood Solid Tumor