French Childhood Cancer Survivor Study (FCCSS)
8 ottobre 2012 aggiornato da: Institut National de la Santé Et de la Recherche Médicale, France
Constitution d'Une Cohorte Nationale rétrospective de Survivants d'un Cancer Solide de l'Enfant diagnostiqué Avant 2000
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.
Panoramica dello studio
Stato
Reclutamento
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Osservativo
Iscrizione (Anticipato)
18000
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Florent F. de Vathaire, Ph.D
- Email: florent.devathaire@igr.fr
Luoghi di studio
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Amiens, Francia, 80054
- Attivo, non reclutante
- Centre Hospital-Universitaire Hôpital Nord
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Angers, Francia, 49933
- Attivo, non reclutante
- Centre Hospitalier-Universitaire
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Besançon, Francia, 25030
- Attivo, non reclutante
- Centre Hospitalier Régional Universitaire Hôpital Saint-Jacques
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Bordeaux, Francia, 33076
- Attivo, non reclutante
- Groupe Hospitalier Pellegrin
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Caen, Francia, 14033
- Attivo, non reclutante
- Centre Hospitalier Universaitaire Hôpital Côte de Nacre
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Clermont Ferrand, Francia, 63003
- Attivo, non reclutante
- Centre Hospitalier Universitaire Hôpial Hôtel Dieu
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Dijon, Francia, 21000
- Attivo, non reclutante
- Centre Hospitalier Universaitaire hôpital d'enfants
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Grenoble, Francia, 38043
- Attivo, non reclutante
- Hôpital La Tronche
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Lille, Francia, 59020
- Attivo, non reclutante
- Centre Oscar Lambret
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Lille, Francia, 59037
- Attivo, non reclutante
- Hôpital Jeanne de Flandre
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Limoges, Francia, 87042
- Attivo, non reclutante
- Hôpital de la mère et de l'enfant
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Lyon, Francia, 69008
- Attivo, non reclutante
- Institut d'Hematologie et Oncologie Pediatrique
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Lyon, Francia, 69373
- Attivo, non reclutante
- Centre Régional de Lutte Contre le Cancer Centre Léon Bérard
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Margency, Francia, 95580
- Attivo, non reclutante
- Hôpital d'Enfants de Margency (HEM) Croix Rouge Française
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Marseille, Francia, 13385
- Attivo, non reclutante
- AP-HM Hôpital de La Timone
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Montpellier, Francia, 34295
- Attivo, non reclutante
- Hopital Arnaud de Villeneuve
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Nantes, Francia, 44093
- Attivo, non reclutante
- Centre Hospitalier Universaitaire Hôpital mère-enfant
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Nice, Francia, 06189
- Reclutamento
- Centre Antoine Lacassagne
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Nice, Francia, 06200
- Attivo, non reclutante
- GCS Hôpitaux pédiatriques Centre Hospitalier Universitaire Lenval
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Paris, Francia, 75248
- Reclutamento
- Institut Curie
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Paris, Francia, 75571
- Attivo, non reclutante
- Hôpital Armand Trousseau
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Poitiers, Francia, 86021
- Attivo, non reclutante
- CHRU de Poitiers La Miletrie
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Reims, Francia, 51056
- Reclutamento
- Institut Jean Godinot
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Reims, Francia, 51090
- Attivo, non reclutante
- Centre Hospitalier Universitaire de Reims Hôpital Maison Blanche
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Rennes, Francia, 35203
- Attivo, non reclutante
- Centre Hospitalier Universitaire Hôpital Sud
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Rouen, Francia, 76038
- Attivo, non reclutante
- Hôpital Charles-Nicolle
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Saint Etienne, Francia, 42055
- Attivo, non reclutante
- Centre Hospitalier Universitaire Hôpital Nord
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Saint-Herblain, Francia, 44805
- Attivo, non reclutante
- Centre René Gauducheau de Nantes Atlantique
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Saintes, Francia, 17108
- Attivo, non reclutante
- Centre Hospitalier de Saintonge
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Strasbourg, Francia, 67098
- Attivo, non reclutante
- Hôpital Hautepierre
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Toulouse, Francia, 31052
- Reclutamento
- Institut Claudius Regaud
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Toulouse, Francia, 31059
- Attivo, non reclutante
- Hopital des Enfants
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Tours, Francia, 37000
- Attivo, non reclutante
- Hôpital Clocheville
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Vandoeuvre-les-Nancy, Francia, 54500
- Attivo, non reclutante
- Hôpital Brabois enfants CHU de Nancy
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Vandoeuvre-les-Nancy, Francia, 54511
- Attivo, non reclutante
- Centre Régional de Lutte Contre le Cancer de Lorraine ALEXIS VAUTRIN
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Villejuif, Francia, 94805
- Reclutamento
- Institut Gustave Roussy
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Non più vecchio di 18 anni (Bambino, Adulto)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
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.
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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Treatment cohort (chemo/radiotherapy)
- those who have survived at least 5 years from the date of diagnosis
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Self-questionnaire cohort
- those with a complete address, who come of age, are still alive and sent back a signed consent agreement
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Medical Insurance cohort
- those who come of age and authorize the access to the medical facilities of the French Health Insurance Information System
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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All health events of interest
Lasso di tempo: by time since diagnosis of solid childhood cancer
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by time since diagnosis of solid childhood cancer
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Collaboratori
Investigatori
- Investigatore principale: Florent F. de Vathaire, Ph.D., Institut National de la Santé Et de la Recherche Médicale, France
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Pein F, Iserin L, de Vathaire F, Lemerle J. [Cardiac toxicity of cancer treatment regimes in children and adolescents: physiopathology, clinical data and the paediatric oncologist's point of view]. Bull Cancer. 2004 Nov;91 Suppl 3:185-91. French.
- 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.
- 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.2011.05.069.
- 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/awr071.
- 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.
- 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.
- 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.
- 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. Erratum In: J Clin Oncol. 2010 Jul 1;28(19):3205.
- 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.
- Nguyen F, Rubino C, Guerin S, Diallo I, Samand A, Hawkins M, Oberlin O, Lefkopoulos D, De Vathaire F. Risk of a second malignant neoplasm after cancer in childhood treated with radiotherapy: correlation with the integral dose restricted to the irradiated fields. Int J Radiat Oncol Biol Phys. 2008 Mar 1;70(3):908-15. doi: 10.1016/j.ijrobp.2007.10.034.
- Guerin S, Hawkins M, Shamsaldin A, Guibout C, Diallo I, Oberlin O, Brugieres L, de Vathaire F. Treatment-adjusted predisposition to second malignant neoplasms after a solid cancer in childhood: a case-control study. J Clin Oncol. 2007 Jul 1;25(19):2833-9. doi: 10.1200/JCO.2006.09.6719.
- Guerin S, Guibout C, Shamsaldin A, Dondon MG, Diallo I, Hawkins M, Oberlin O, Hartmann O, Michon J, Le Deley MC, de Vathaire F. Concomitant chemo-radiotherapy and local dose of radiation as risk factors for second malignant neoplasms after solid cancer in childhood: a case-control study. Int J Cancer. 2007 Jan 1;120(1):96-102. doi: 10.1002/ijc.22197.
- Haddy N, Le Deley MC, Samand A, Diallo I, Guerin S, Guibout C, Oberlin O, Hawkins M, Zucker JM, de Vathaire F. Role of radiotherapy and chemotherapy in the risk of secondary leukaemia after a solid tumour in childhood. Eur J Cancer. 2006 Nov;42(16):2757-64. doi: 10.1016/j.ejca.2006.05.034. Epub 2006 Sep 11.
- Guibout C, Adjadj E, Rubino C, Shamsaldin A, Grimaud E, Hawkins M, Mathieu MC, Oberlin O, Zucker JM, Panis X, Lagrange JL, Daly-Schveitzer N, Chavaudra J, de Vathaire F. Malignant breast tumors after radiotherapy for a first cancer during childhood. J Clin Oncol. 2005 Jan 1;23(1):197-204. doi: 10.1200/JCO.2005.06.225.
- Menu-Branthomme A, Rubino C, Shamsaldin A, Hawkins MM, Grimaud E, Dondon MG, Hardiman C, Vassal G, Campbell S, Panis X, Daly-Schveitzer N, Lagrange JL, Zucker JM, Chavaudra J, Hartman O, de Vathaire F. Radiation dose, chemotherapy and risk of soft tissue sarcoma after solid tumours during childhood. Int J Cancer. 2004 May 20;110(1):87-93. doi: 10.1002/ijc.20002.
- Rubino C, Adjadj E, Guerin S, Guibout C, Shamsaldin A, Dondon MG, Valteau-Couanet D, Hartmann O, Hawkins M, de Vathaire F. Long-term risk of second malignant neoplasms after neuroblastoma in childhood: role of treatment. Int J Cancer. 2003 Dec 10;107(5):791-6. doi: 10.1002/ijc.11455.
- Guerin S, Dupuy A, Anderson H, Shamsaldin A, Svahn-Tapper G, Moller T, Quiniou E, Garwicz S, Hawkins M, Avril MF, Oberlin O, Chavaudra J, de Vathaire F. Radiation dose as a risk factor for malignant melanoma following childhood cancer. Eur J Cancer. 2003 Nov;39(16):2379-86. doi: 10.1016/s0959-8049(03)00663-4.
- de Vathaire F, Hardiman C, Shamsaldin A, Campbell S, Grimaud E, Hawkins M, Raquin M, Oberlin O, Diallo I, Zucker JM, Panis X, Lagrange JL, Daly-Schveitzer N, Lemerle J, Chavaudra J, Schlumberger M, Bonaiti C. Thyroid carcinomas after irradiation for a first cancer during childhood. Arch Intern Med. 1999 Dec 13-27;159(22):2713-9. doi: 10.1001/archinte.159.22.2713.
- de Vathaire F, Hawkins M, Campbell S, Oberlin O, Raquin MA, Schlienger JY, Shamsaldin A, Diallo I, Bell J, Grimaud E, Hardiman C, Lagrange JL, Daly-Schveitzer N, Panis X, Zucker JM, Sancho-Garnier H, Eschwege F, Chavaudra J, Lemerle J. Second malignant neoplasms after a first cancer in childhood: temporal pattern of risk according to type of treatment. Br J Cancer. 1999 Apr;79(11-12):1884-93. doi: 10.1038/sj.bjc.6690300.
- Little MP, de Vathaire F, Shamsaldin A, Oberlin O, Campbell S, Grimaud E, Chavaudra J, Haylock RG, Muirhead CR. Risks of brain tumour following treatment for cancer in childhood: modification by genetic factors, radiotherapy and chemotherapy. Int J Cancer. 1998 Oct 29;78(3):269-75. doi: 10.1002/(SICI)1097-0215(19981029)78:33.0.CO;2-T.
- Le Vu B, de Vathaire F, Shamsaldin A, Hawkins MM, Grimaud E, Hardiman C, Diallo I, Vassal G, Bessa E, Campbell S, Panis X, Daly-Schveitzer N, Lagrange JL, Zucker JM, Eschwege F, Chavaudra J, Lemerle J. Radiation dose, chemotherapy and risk of osteosarcoma after solid tumours during childhood. Int J Cancer. 1998 Jul 29;77(3):370-7. doi: 10.1002/(sici)1097-0215(19980729)77:33.0.co;2-c.
- de Vathaire F, Shamsaldin A, Grimaud E, Campbell S, Guerra M, Raquin M, Bessa E, Hardiman C, Jan P, Rumeau N, et al. Solid malignant neoplasms after childhood irradiation: decrease of the relative risk with time after irradiation. C R Acad Sci III. 1995 Apr;318(4):483-90.
- Pein F, Sakiroglu O, Dahan M, Lebidois J, Merlet P, Shamsaldin A, Villain E, de Vathaire F, Sidi D, Hartmann O. Cardiac abnormalities 15 years and more after adriamycin therapy in 229 childhood survivors of a solid tumour at the Institut Gustave Roussy. Br J Cancer. 2004 Jul 5;91(1):37-44. doi: 10.1038/sj.bjc.6601904.
- Guldner L, Haddy N, Pein F, Diallo I, Shamsaldin A, Dahan M, Lebidois J, Merlet P, Villain E, Sidi D, Sakiroglu O, Hartmann O, Leftakopoulos D, de Vathaire F. Radiation dose and long term risk of cardiac pathology following radiotherapy and anthracyclin for a childhood cancer. Radiother Oncol. 2006 Oct;81(1):47-56. doi: 10.1016/j.radonc.2006.08.020. Epub 2006 Sep 20.
- Shamsaldin A, Grimaud E, Hardiman C, Diallo I, de-Vathaire F, Chavaudra J. Dose distribution throughout the body from radiotherapy for Hodgkin's disease in childhood. Radiother Oncol. 1998 Oct;49(1):85-90. doi: 10.1016/s0167-8140(98)00110-8.
- de Vathaire F, Francois P, Schlumberger M, Schweisguth O, Hardiman C, Grimaud E, Oberlin O, Hill C, Lemerle J, Flamant R. Epidemiological evidence for a common mechanism for neuroblastoma and differentiated thyroid tumour. Br J Cancer. 1992 Mar;65(3):425-8. doi: 10.1038/bjc.1992.87.
- de Vathaire F, Francois P, Hill C, Schweisguth O, Rodary C, Sarrazin D, Oberlin O, Beurtheret C, Dutreix A, Flamant R. Role of radiotherapy and chemotherapy in the risk of second malignant neoplasms after cancer in childhood. Br J Cancer. 1989 May;59(5):792-6. doi: 10.1038/bjc.1989.165.
- de Vathaire F, Schweisguth O, Rodary C, Francois P, Sarrazin D, Oberlin O, Hill C, Raquin MA, Dutreix A, Flamant R. Long-term risk of second malignant neoplasm after a cancer in childhood. Br J Cancer. 1989 Mar;59(3):448-52. doi: 10.1038/bjc.1989.92.
- de Vathaire F, Francois P, Schweisguth O, Oberlin O, Le MG. Irradiated neuroblastoma in childhood as potential risk factor for subsequent thyroid tumour. Lancet. 1988 Aug 20;2(8608):455. doi: 10.1016/s0140-6736(88)90445-x. No abstract available.
- de Vathaire F, El-Fayech C, Ben Ayed FF, Haddy N, Guibout C, Winter D, Thomas-Teinturier C, Veres C, Jackson A, Pacquement H, Schlumberger M, Hawkins M, Diallo I, Oberlin O. Radiation dose to the pancreas and risk of diabetes mellitus in childhood cancer survivors: a retrospective cohort study. Lancet Oncol. 2012 Oct;13(10):1002-10. doi: 10.1016/S1470-2045(12)70323-6. Epub 2012 Aug 23.
- de Vathaire F, Haddy N, Allodji RS, Hawkins M, Guibout C, El-Fayech C, Teinturier C, Oberlin O, Pacquement H, Diop F, Kalhouche A, Benadjaoud M, Winter D, Jackson A, Bezin Mai-Quynh G, Benabdennebi A, Llanas D, Veres C, Munzer M, Nguyen TD, Bondiau PY, Berchery D, Laprie A, Deutsch E, Lefkopoulos D, Schlumberger M, Diallo I, Rubino C. Thyroid Radiation Dose and Other Risk Factors of Thyroid Carcinoma Following Childhood Cancer. J Clin Endocrinol Metab. 2015 Nov;100(11):4282-90. doi: 10.1210/jc.2015-1690. Epub 2015 Sep 1.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 novembre 2011
Completamento dello studio (Anticipato)
1 novembre 2031
Date di iscrizione allo studio
Primo inviato
13 giugno 2012
Primo inviato che soddisfa i criteri di controllo qualità
14 giugno 2012
Primo Inserito (Stima)
15 giugno 2012
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
10 ottobre 2012
Ultimo aggiornamento inviato che soddisfa i criteri QC
8 ottobre 2012
Ultimo verificato
1 ottobre 2012
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- C12-25
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Tumore solido infantile
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RezoluteA disposizioneIperinsulinismo associato a tumore (Tumor HI)
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AstraZenecaAttivo, non reclutanteAdv Solid Malig - H&N SCC, ATM Pro / Def NSCLC, carcinoma gastrico, mammario e ovaricoStati Uniti, Francia, Regno Unito, Corea del Sud