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French Childhood Cancer Survivor Study (FCCSS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01620372
Recruitment Status : Recruiting
First Posted : June 15, 2012
Last Update Posted : October 10, 2012
Ligue contre le cancer, France
National Research Agency, France
Programme hospitalier de recherche clinique, France
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

Brief Summary:

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

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 18000 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Self-questionnaire cohort
- 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

Primary Outcome Measures :
  1. 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
saliva and blood samples (under another protocol)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study population includes all types of solid childhood cancer cases (with the exception of leukemia) treated in, or before the end of, 1999.

The study population is based on the French clinical trials, registries, cohorts and department of paediatric oncology.


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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01620372

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Contact: Florent F. de Vathaire, Ph.D

Show Show 36 study locations
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Ligue contre le cancer, France
National Research Agency, France
Programme hospitalier de recherche clinique, France
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Principal Investigator: Florent F. de Vathaire, Ph.D. Institut National de la Santé Et de la Recherche Médicale, France
Additional Information:
Publications of Results:

Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France Identifier: NCT01620372    
Other Study ID Numbers: C12-25
First Posted: June 15, 2012    Key Record Dates
Last Update Posted: October 10, 2012
Last Verified: October 2012