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FCCSS: French Childhood Cancer Survivor Study

Sponsor
Institut National de la Santé Et de la Recherche Médicale, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT01620372
Collaborator
Ligue contre le cancer, France (Other), National Research Agency, France (Other), Programme hospitalier de recherche clinique, France (Other)
18,000
Enrollment
36
Locations
240
Duration (Months)
500
Patients Per Site
2.1
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated 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 :
    Nov 1, 2011
    Anticipated Study Completion Date :
    Nov 1, 2031

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. All health events of interest [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,...)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre Hospital-Universitaire Hôpital Nord Amiens France 80054
    2 Centre Hospitalier-Universitaire Angers France 49933
    3 Centre Hospitalier Régional Universitaire Hôpital Saint-Jacques Besançon France 25030
    4 Groupe hospitalier Pellegrin Bordeaux France 33076
    5 Centre Hospitalier Universaitaire Hôpital Côte de Nacre Caen France 14033
    6 Centre Hospitalier Universitaire Hôpial Hôtel Dieu Clermont Ferrand France 63003
    7 Centre Hospitalier Universaitaire hôpital d'enfants Dijon France 21000
    8 Hôpital La Tronche Grenoble France 38043
    9 Centre Oscar Lambret Lille France 59020
    10 Hôpital Jeanne De Flandre Lille France 59037
    11 Hôpital de la mère et de l'enfant Limoges France 87042
    12 Institut d'Hématologie et Oncologie Pédiatrique Lyon France 69008
    13 Centre Régional de Lutte Contre le Cancer Centre Léon Bérard Lyon France 69373
    14 Hôpital d'Enfants de Margency (HEM) Croix Rouge Française Margency France 95580
    15 AP-HM Hôpital de la Timone Marseille France 13385
    16 Hôpital Arnaud De Villeneuve Montpellier France 34295
    17 Centre Hospitalier Universaitaire Hôpital mère-enfant Nantes France 44093
    18 Centre Antoine Lacassagne Nice France 06189
    19 GCS Hôpitaux pédiatriques Centre Hospitalier Universitaire Lenval Nice France 06200
    20 Institut Curie Paris France 75248
    21 Hôpital Armand Trousseau Paris France 75571
    22 CHRU de Poitiers La Miletrie Poitiers France 86021
    23 Institut Jean Godinot Reims France 51056
    24 Centre Hospitalier Universitaire de Reims Hôpital Maison Blanche Reims France 51090
    25 Centre Hospitalier Universitaire Hôpital Sud Rennes France 35203
    26 Hôpital Charles-Nicolle Rouen France 76038
    27 Centre Hospitalier Universitaire Hôpital Nord Saint Etienne France 42055
    28 Centre René Gauducheau de Nantes Atlantique Saint-Herblain France 44805
    29 Centre Hospitalier de Saintonge Saintes France 17108
    30 Hôpital Hautepierre Strasbourg France 67098
    31 Institut Claudius Regaud Toulouse France 31052
    32 Hôpital des Enfants Toulouse France 31059
    33 Hôpital Clocheville Tours France 37000
    34 Hôpital Brabois enfants CHU de Nancy Vandoeuvre-les-Nancy France 54500
    35 Centre Régional de Lutte Contre le Cancer de Lorraine ALEXIS VAUTRIN Vandoeuvre-les-Nancy France 54511
    36 Institut Gustave Roussy Villejuif France 94805

    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

    Investigators

    • Principal Investigator: Florent F. de Vathaire, Ph.D., Institut National de la Santé Et de la Recherche Médicale, France

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Institut National de la Santé Et de la Recherche Médicale, France
    ClinicalTrials.gov Identifier:
    NCT01620372
    Other Study ID Numbers:
    • C12-25
    First Posted:
    Jun 15, 2012
    Last Update Posted:
    Oct 10, 2012
    Last Verified:
    Oct 1, 2012

    Study Results

    No Results Posted as of Oct 10, 2012