French Childhood Cancer Survivor Study

Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• All health events of interest [Срок оценки: by time since diagnosis of solid childhood cancer]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• Leukaemia cases

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 36 центров

• Centre Hospital-Universitaire Hôpital Nord — Amiens
• Centre Hospitalier-Universitaire — Angers
• Centre Hospitalier Régional Universitaire Hôpital Saint-Jacques — Besançon
• Groupe hospitalier Pellegrin — Bordeaux
• Centre Hospitalier Universaitaire Hôpital Côte de Nacre — Caen
• Centre Hospitalier Universitaire Hôpial Hôtel Dieu — Clermont-Ferrand
• Centre Hospitalier Universaitaire hôpital d'enfants — Dijon
• Hôpital La Tronche — Grenoble
• … и ещё 28 центров

Публикации

• Haddy N, El-Fayech C, Guibout C, Adjadj E, Thomas-Teinturier C, Oberlin O, Veres C, Pacquement H, Jackson A, Munzer M, N'Guyen TD, Bondiau PY, Berchery D, Laprie A, Bridier A, Lefkopoulos D, Schlumberger M, Rubino C, Diallo I, de Vathaire F. Thyroid adenomas after solid cancer in childhood. Int J Radiat Oncol Biol Phys. 2012 Oct 1;84(2):e209-15. doi: 10.1016/j.ijrobp.2012.03.044. Epub 2012 Jun 5. PMID 22672756
• Tukenova M, Diallo I, Anderson H, Hawkins M, Garwicz S, Sankila R, El Fayech C, Winter D, Rubino C, Adjadj E, Haddy N, Oberlin O, Moller T, Langmark F, Tryggvadottir L, Pacquement H, Svahn-Tapper G, de Vathaire F. Second malignant neoplasms in digestive organs after childhood cancer: a cohort-nested case-control study. Int J Radiat Oncol Biol Phys. 2012 Mar 1;82(3):e383-90. doi: 10.1016/j.ijrobp.2 PMID 22284034
• Haddy N, Mousannif A, Tukenova M, Guibout C, Grill J, Dhermain F, Pacquement H, Oberlin O, El-Fayech C, Rubino C, Thomas-Teinturier C, Le-Deley MC, Hawkins M, Winter D, Chavaudra J, Diallo I, de Vathaire F. Relationship between the brain radiation dose for the treatment of childhood cancer and the risk of long-term cerebrovascular mortality. Brain. 2011 May;134(Pt 5):1362-72. doi: 10.1093/brain/aw PMID 21596770
• Dufour C, Oberlin O, De Vathaire F. [Offspring of childhood cancer survivors]. Arch Pediatr. 2010 Jun;17(6):926-7. doi: 10.1016/S0929-693X(10)70182-2. No abstract available. French. PMID 20654964
• Tukenova M, Guibout C, Hawkins M, Quiniou E, Mousannif A, Pacquement H, Winter D, Bridier A, Lefkopoulos D, Oberlin O, Diallo I, de Vathaire F. Radiation therapy and late mortality from second sarcoma, carcinoma, and hematological malignancies after a solid cancer in childhood. Int J Radiat Oncol Biol Phys. 2011 Jun 1;80(2):339-46. doi: 10.1016/j.ijrobp.2010.02.004. Epub 2010 Jun 18. PMID 20646844
• Tukenova M, Diallo I, Hawkins M, Guibout C, Quiniou E, Pacquement H, Dhermain F, Shamsaldin A, Oberlin O, de Vathaire F. Long-term mortality from second malignant neoplasms in 5-year survivors of solid childhood tumors: temporal pattern of risk according to type of treatment. Cancer Epidemiol Biomarkers Prev. 2010 Mar;19(3):707-15. doi: 10.1158/1055-9965.EPI-09-1156. Epub 2010 Mar 3. PMID 20200431
• Tukenova M, Guibout C, Oberlin O, Doyon F, Mousannif A, Haddy N, Guerin S, Pacquement H, Aouba A, Hawkins M, Winter D, Bourhis J, Lefkopoulos D, Diallo I, de Vathaire F. Role of cancer treatment in long-term overall and cardiovascular mortality after childhood cancer. J Clin Oncol. 2010 Mar 10;28(8):1308-15. doi: 10.1200/JCO.2008.20.2267. Epub 2010 Feb 8. PMID 20142603
• Diallo I, Haddy N, Adjadj E, Samand A, Quiniou E, Chavaudra J, Alziar I, Perret N, Guerin S, Lefkopoulos D, de Vathaire F. Frequency distribution of second solid cancer locations in relation to the irradiated volume among 115 patients treated for childhood cancer. Int J Radiat Oncol Biol Phys. 2009 Jul 1;74(3):876-83. doi: 10.1016/j.ijrobp.2009.01.040. Epub 2009 Apr 20. PMID 19386434

Идентификаторы

NCT: NCT01620372 · C12-25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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