French Childhood Cancer Survivor Study (FCCSS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Institut National de la Santé Et de la Recherche Médicale, France
Sponsor:
Collaborators:
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
ClinicalTrials.gov Identifier:
NCT01620372
First received: June 13, 2012
Last updated: October 8, 2012
Last verified: October 2012
  Purpose

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
Childhood Solid Tumor

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • All health events of interest [ Time Frame: by time since diagnosis of solid childhood cancer ] [ Designated as safety issue: No ]
    • 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)


Estimated Enrollment: 18000
Study Start Date: November 2011
Estimated Study Completion Date: November 2031
Groups/Cohorts
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

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.
  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
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.

Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01620372

Contacts
Contact: Florent F. de Vathaire, Ph.D florent.devathaire@igr.fr

Locations
France
Centre Hospital-Universitaire Hôpital Nord Active, not recruiting
Amiens, France, 80054
Centre Hospitalier-Universitaire Active, not recruiting
Angers, France, 49933
Centre Hospitalier Régional Universitaire Hôpital Saint-Jacques Active, not recruiting
Besançon, France, 25030
Groupe hospitalier Pellegrin Active, not recruiting
Bordeaux, France, 33076
Centre Hospitalier Universaitaire Hôpital Côte de Nacre Active, not recruiting
Caen, France, 14033
Centre Hospitalier Universitaire Hôpial Hôtel Dieu Active, not recruiting
Clermont Ferrand, France, 63003
Centre Hospitalier Universaitaire hôpital d'enfants Active, not recruiting
Dijon, France, 21000
Hôpital La Tronche Active, not recruiting
Grenoble, France, 38043
Hôpital Jeanne De Flandre Active, not recruiting
Lille, France, 59037
Centre Oscar Lambret Active, not recruiting
Lille, France, 59020
Hôpital de la mère et de l'enfant Active, not recruiting
Limoges, France, 87042
Centre Régional de Lutte Contre le Cancer Centre Léon Bérard Active, not recruiting
Lyon, France, 69373
Institut d'Hématologie et Oncologie Pédiatrique Active, not recruiting
Lyon, France, 69008
Hôpital d'Enfants de Margency (HEM) Croix Rouge Française Active, not recruiting
Margency, France, 95580
AP-HM Hôpital de la Timone Active, not recruiting
Marseille, France, 13385
Hôpital Arnaud De Villeneuve Active, not recruiting
Montpellier, France, 34295
Centre Hospitalier Universaitaire Hôpital mère-enfant Active, not recruiting
Nantes, France, 44093
Centre Antoine Lacassagne Recruiting
Nice, France, 06189
GCS Hôpitaux pédiatriques Centre Hospitalier Universitaire Lenval Active, not recruiting
Nice, France, 06200
Institut Curie Recruiting
Paris, France, 75248
Hôpital Armand Trousseau Active, not recruiting
Paris, France, 75571
CHRU de Poitiers La Miletrie Active, not recruiting
Poitiers, France, 86021
Centre Hospitalier Universitaire de Reims Hôpital Maison Blanche Active, not recruiting
Reims, France, 51090
Institut Jean Godinot Recruiting
Reims, France, 51056
Centre Hospitalier Universitaire Hôpital Sud Active, not recruiting
Rennes, France, 35203
Hôpital Charles-Nicolle Active, not recruiting
Rouen, France, 76038
Centre Hospitalier Universitaire Hôpital Nord Active, not recruiting
Saint Etienne, France, 42055
Centre René Gauducheau de Nantes Atlantique Active, not recruiting
Saint-Herblain, France, 44805
Centre Hospitalier de Saintonge Active, not recruiting
Saintes, France, 17108
Hôpital Hautepierre Active, not recruiting
Strasbourg, France, 67098
Hôpital des Enfants Active, not recruiting
Toulouse, France, 31059
Institut Claudius Regaud Recruiting
Toulouse, France, 31052
Hôpital Clocheville Active, not recruiting
Tours, France, 37000
Hôpital Brabois enfants CHU de Nancy Active, not recruiting
Vandoeuvre-les-Nancy, France, 54500
Centre Régional de Lutte Contre le Cancer de Lorraine ALEXIS VAUTRIN Active, not recruiting
Vandoeuvre-les-Nancy, France, 54511
Institut Gustave Roussy Recruiting
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
  More Information

Publications:

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01620372     History of Changes
Other Study ID Numbers: C12-25
Study First Received: June 13, 2012
Last Updated: October 8, 2012
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: The Commission nationale de l’informatique et des libertés

ClinicalTrials.gov processed this record on August 19, 2014