French Childhood Cancer Survivor Study (FCCSS)
2012년 10월 8일 업데이트: 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.
연구 개요
상태
모병
정황
상세 설명
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.
연구 유형
관찰
등록 (예상)
18000
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Florent F. de Vathaire, Ph.D
- 이메일: florent.devathaire@igr.fr
연구 장소
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Amiens, 프랑스, 80054
- 모집하지 않고 적극적으로
- Centre Hospital-Universitaire Hôpital Nord
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Angers, 프랑스, 49933
- 모집하지 않고 적극적으로
- Centre Hospitalier-Universitaire
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Besançon, 프랑스, 25030
- 모집하지 않고 적극적으로
- Centre Hospitalier Régional Universitaire Hôpital Saint-Jacques
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Bordeaux, 프랑스, 33076
- 모집하지 않고 적극적으로
- Groupe Hospitalier Pellegrin
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Caen, 프랑스, 14033
- 모집하지 않고 적극적으로
- Centre Hospitalier Universaitaire Hôpital Côte de Nacre
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Clermont Ferrand, 프랑스, 63003
- 모집하지 않고 적극적으로
- Centre Hospitalier Universitaire Hôpial Hôtel Dieu
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Dijon, 프랑스, 21000
- 모집하지 않고 적극적으로
- Centre Hospitalier Universaitaire hôpital d'enfants
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Grenoble, 프랑스, 38043
- 모집하지 않고 적극적으로
- Hôpital La Tronche
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Lille, 프랑스, 59020
- 모집하지 않고 적극적으로
- Centre Oscar Lambret
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Lille, 프랑스, 59037
- 모집하지 않고 적극적으로
- Hôpital Jeanne de Flandre
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Limoges, 프랑스, 87042
- 모집하지 않고 적극적으로
- Hôpital de la mère et de l'enfant
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Lyon, 프랑스, 69008
- 모집하지 않고 적극적으로
- Institut d'Hematologie et Oncologie Pediatrique
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Lyon, 프랑스, 69373
- 모집하지 않고 적극적으로
- Centre Régional de Lutte Contre le Cancer Centre Léon Bérard
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Margency, 프랑스, 95580
- 모집하지 않고 적극적으로
- Hôpital d'Enfants de Margency (HEM) Croix Rouge Française
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Marseille, 프랑스, 13385
- 모집하지 않고 적극적으로
- AP-HM Hôpital de La Timone
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Montpellier, 프랑스, 34295
- 모집하지 않고 적극적으로
- Hopital Arnaud de Villeneuve
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Nantes, 프랑스, 44093
- 모집하지 않고 적극적으로
- Centre Hospitalier Universaitaire Hôpital mère-enfant
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Nice, 프랑스, 06189
- 모병
- Centre Antoine Lacassagne
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Nice, 프랑스, 06200
- 모집하지 않고 적극적으로
- GCS Hôpitaux pédiatriques Centre Hospitalier Universitaire Lenval
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Paris, 프랑스, 75248
- 모병
- Institut Curie
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Paris, 프랑스, 75571
- 모집하지 않고 적극적으로
- Hôpital Armand Trousseau
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Poitiers, 프랑스, 86021
- 모집하지 않고 적극적으로
- CHRU de Poitiers La Miletrie
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Reims, 프랑스, 51056
- 모병
- Institut Jean Godinot
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Reims, 프랑스, 51090
- 모집하지 않고 적극적으로
- Centre Hospitalier Universitaire de Reims Hôpital Maison Blanche
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Rennes, 프랑스, 35203
- 모집하지 않고 적극적으로
- Centre Hospitalier Universitaire Hôpital Sud
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Rouen, 프랑스, 76038
- 모집하지 않고 적극적으로
- Hôpital Charles-Nicolle
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Saint Etienne, 프랑스, 42055
- 모집하지 않고 적극적으로
- Centre Hospitalier Universitaire Hôpital Nord
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Saint-Herblain, 프랑스, 44805
- 모집하지 않고 적극적으로
- Centre René Gauducheau de Nantes Atlantique
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Saintes, 프랑스, 17108
- 모집하지 않고 적극적으로
- Centre Hospitalier de Saintonge
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Strasbourg, 프랑스, 67098
- 모집하지 않고 적극적으로
- Hôpital Hautepierre
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Toulouse, 프랑스, 31052
- 모병
- Institut Claudius Regaud
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Toulouse, 프랑스, 31059
- 모집하지 않고 적극적으로
- Hopital Des Enfants
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Tours, 프랑스, 37000
- 모집하지 않고 적극적으로
- Hôpital Clocheville
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Vandoeuvre-les-Nancy, 프랑스, 54500
- 모집하지 않고 적극적으로
- Hôpital Brabois enfants CHU de Nancy
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Vandoeuvre-les-Nancy, 프랑스, 54511
- 모집하지 않고 적극적으로
- Centre Régional de Lutte Contre le Cancer de Lorraine ALEXIS VAUTRIN
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Villejuif, 프랑스, 94805
- 모병
- Institut Gustave Roussy
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이하 (어린이, 성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
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.
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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All health events of interest
기간: by time since diagnosis of solid childhood cancer
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by time since diagnosis of solid childhood cancer
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
수사관
- 수석 연구원: Florent F. de Vathaire, Ph.D., Institut National de la Santé Et de la Recherche Médicale, France
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2011년 11월 1일
연구 완료 (예상)
2031년 11월 1일
연구 등록 날짜
최초 제출
2012년 6월 13일
QC 기준을 충족하는 최초 제출
2012년 6월 14일
처음 게시됨 (추정)
2012년 6월 15일
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추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- C12-25
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
어린 시절 고형 종양에 대한 임상 시험
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AstraZeneca모집하지 않고 적극적으로Adv Solid Malig - H&N SCC, ATM Pro / Def NSCLC, 위암, 유방암 및 난소암미국, 프랑스, 영국, 대한민국