Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT01620372 En recrutement IDF

Titre

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

Type

Observational

Pathologie

Phase

Promoteur

Institut National de la Santé Et de la Recherche Médicale, France (Voir sur ClinicalTrials)

Date de début

novembre 2011

Date de fin

novembre 2031

Dernière mise à jour

29 juin 2024

Résumé

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.

Détail

Voir le détail 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. Fermer le détail

Etablissements

Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
AP-HP - Hôpital Armand Trousseau-La Roche Guyon	Active, sans recrutement	Contact (sur clinicalTrials)
CLCC INSTITUT CURIE	En recrutement IDF	Contact (sur clinicalTrials)
CLCC INSTITUT GUSTAVE ROUSSY	En recrutement IDF	Contact (sur clinicalTrials)
HOPITAL D ENFANTS MARGENCY	Active, sans recrutement	Contact (sur clinicalTrials)
Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Centre Antoine Lacassagne - 06189 - Nice - France	En recrutement	Contact (sur clinicalTrials)
Centre Hospitalier de Saintonge - 17108 - Saintes - France	Active, sans recrutement	Contact (sur clinicalTrials)
Centre Hospitalier Régional Universitaire Hôpital Saint-Jacques - 25030 - Besançon - France	Active, sans recrutement	Contact (sur clinicalTrials)
Centre Hospitalier Universaitaire Hôpital Côte de Nacre - 14033 - Caen - France	Active, sans recrutement	Contact (sur clinicalTrials)
Centre Hospitalier Universaitaire hôpital d'enfants - 21000 - Dijon - France	Active, sans recrutement	Contact (sur clinicalTrials)
Centre Hospitalier Universitaire de Reims Hôpital Maison Blanche - 51090 - Reims - France	Active, sans recrutement	Contact (sur clinicalTrials)
Centre Hospitalier Universitaire Hôpital Nord - 42055 - Saint Etienne - France	Active, sans recrutement	Contact (sur clinicalTrials)
Centre Hospitalier-Universitaire - 49933 - Angers - France	Active, sans recrutement	Contact (sur clinicalTrials)
Centre Hospital-Universitaire Hôpital Nord - 80054 - Amiens - France	Active, sans recrutement	Contact (sur clinicalTrials)
Centre Oscar Lambret - 59020 - Lille - France	Active, sans recrutement	Contact (sur clinicalTrials)
Centre Régional de Lutte Contre le Cancer Centre Léon Bérard - 69373 - Lyon - France	Active, sans recrutement	Contact (sur clinicalTrials)
Centre Régional de Lutte Contre le Cancer de Lorraine ALEXIS VAUTRIN - 54511 - Vandoeuvre-les-Nancy - France	Active, sans recrutement	Contact (sur clinicalTrials)
Centre René Gauducheau de Nantes Atlantique - 44805 - Saint-Herblain - France	Active, sans recrutement	Contact (sur clinicalTrials)
GCS Hôpitaux pédiatriques Centre Hospitalier Universitaire Lenval - 06200 - Nice - France	Active, sans recrutement	Contact (sur clinicalTrials)
Groupe hospitalier Pellegrin - 33076 - Bordeaux - France	Active, sans recrutement	Contact (sur clinicalTrials)
Hôpital Arnaud De Villeneuve - 34295 - Montpellier - France	Active, sans recrutement	Contact (sur clinicalTrials)
Hôpital Brabois enfants CHU de Nancy - 54500 - Vandoeuvre-les-Nancy - France	Active, sans recrutement	Contact (sur clinicalTrials)
Hôpital Charles-Nicolle - 76038 - Rouen - France	Active, sans recrutement	Contact (sur clinicalTrials)
Hôpital Clocheville - 37000 - Tours - France	Active, sans recrutement	Contact (sur clinicalTrials)
Hôpital de la mère et de l'enfant - 87042 - Limoges - France	Active, sans recrutement	Contact (sur clinicalTrials)
Hôpital Jeanne De Flandre - 59037 - Lille - France	Active, sans recrutement	Contact (sur clinicalTrials)
Hôpital La Tronche - 38043 - Grenoble - France	Active, sans recrutement	Contact (sur clinicalTrials)
Institut Claudius Regaud - 31052 - Toulouse - France	En recrutement	Contact (sur clinicalTrials)
Institut d'Hématologie et Oncologie Pédiatrique - 69008 - Lyon - France	Active, sans recrutement	Contact (sur clinicalTrials)
Institut Jean Godinot - 51056 - Reims - France	En recrutement	Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
AP-HM Hôpital de la Timone - 13385 - Marseille - France	Active, sans recrutement	Contact (sur clinicalTrials)
Centre Hospitalier Universaitaire Hôpital mère-enfant - 44093 - Nantes - France	Active, sans recrutement	Contact (sur clinicalTrials)
Centre Hospitalier Universitaire Hôpial Hôtel Dieu - 63003 - Clermont Ferrand - France	Active, sans recrutement	Contact (sur clinicalTrials)
Centre Hospitalier Universitaire Hôpital Sud - 35203 - Rennes - France	Active, sans recrutement	Contact (sur clinicalTrials)
CHRU de Poitiers La Miletrie - 86021 - Poitiers - France	Active, sans recrutement	Contact (sur clinicalTrials)
Hôpital des Enfants - 31059 - Toulouse - France	Active, sans recrutement	Contact (sur clinicalTrials)
Hôpital Hautepierre - 67098 - Strasbourg - France	Active, sans recrutement	Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

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)

Critère de non inclusion

- Leukaemia cases

NCT01620372 - Constitution d'Une Cohorte Nationale rétrospective de Survivants d'un Cancer Solide de l'Enfant diagnostiqué Avant 2000 (FCCSS)

Informations générales
Etablissements
Critères
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