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Spots Global Cancer Trial Database for French Childhood Cancer Survivor Study

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Trial Identification

Brief Title: French Childhood Cancer Survivor Study

Official Title: Constitution d'Une Cohorte Nationale r茅trospective de Survivants d'un Cancer Solide de l'Enfant diagnostiqu茅 Avant 2000

Study ID: NCT01620372

Interventions

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.

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.

Keywords

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Centre Hospital-Universitaire H么pital Nord, Amiens, , France

Centre Hospitalier-Universitaire, Angers, , France

Centre Hospitalier R茅gional Universitaire H么pital Saint-Jacques, Besan莽on, , France

Groupe hospitalier Pellegrin, Bordeaux, , France

Centre Hospitalier Universaitaire H么pital C么te de Nacre, Caen, , France

Centre Hospitalier Universitaire H么pial H么tel Dieu, Clermont Ferrand, , France

Centre Hospitalier Universaitaire h么pital d'enfants, Dijon, , France

H么pital La Tronche, Grenoble, , France

Centre Oscar Lambret, Lille, , France

H么pital Jeanne De Flandre, Lille, , France

H么pital de la m猫re et de l'enfant, Limoges, , France

Institut d'H茅matologie et Oncologie P茅diatrique, Lyon, , France

Centre R茅gional de Lutte Contre le Cancer Centre L茅on B茅rard, Lyon, , France

H么pital d'Enfants de Margency (HEM) Croix Rouge Fran莽aise, Margency, , France

AP-HM H么pital de la Timone, Marseille, , France

H么pital Arnaud De Villeneuve, Montpellier, , France

Centre Hospitalier Universaitaire H么pital m猫re-enfant, Nantes, , France

Centre Antoine Lacassagne, Nice, , France

GCS H么pitaux p茅diatriques Centre Hospitalier Universitaire Lenval, Nice, , France

Institut Curie, Paris, , France

H么pital Armand Trousseau, Paris, , France

CHRU de Poitiers La Miletrie, Poitiers, , France

Institut Jean Godinot, Reims, , France

Centre Hospitalier Universitaire de Reims H么pital Maison Blanche, Reims, , France

Centre Hospitalier Universitaire H么pital Sud, Rennes, , France

H么pital Charles-Nicolle, Rouen, , France

Centre Hospitalier Universitaire H么pital Nord, Saint Etienne, , France

Centre Ren茅 Gauducheau de Nantes Atlantique, Saint-Herblain, , France

Centre Hospitalier de Saintonge, Saintes, , France

H么pital Hautepierre, Strasbourg, , France

Institut Claudius Regaud, Toulouse, , France

H么pital des Enfants, Toulouse, , France

H么pital Clocheville, Tours, , France

H么pital Brabois enfants CHU de Nancy, Vandoeuvre-les-Nancy, , France

Centre R茅gional de Lutte Contre le Cancer de Lorraine ALEXIS VAUTRIN, Vandoeuvre-les-Nancy, , France

Institut Gustave Roussy, Villejuif, , France

Contact Details

Name: Florent F. de Vathaire, Ph.D.

Affiliation: Institut National de la Sant茅 Et de la Recherche M茅dicale, France

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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