French Childhood Cancer Survivor Study

NCT01620372 | Recruiting DMC

• 1 other identifier: C12-25
• Study Type: observational
• Target: 18,000
• Locations: 1 country
• Sites: 36

Brief Summary

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.

Conditions

Childhood Solid Tumor

Outcome Measures

Primary Outcomes (1)

• All health events of interest

  * all causes mortality (e.g. cerebrovascular, cardiovascular,...) * all iatrogenic events (e.g. diabetes, thyroid adenomas, cardiac diseases, second malignant solid tumors, secondary leukemia,...)

  by time since diagnosis of solid childhood cancer

Study Arms (3)

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

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• Leukaemia cases

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead
• Ligue contre le cancer, France: collaborator
• National Research Agency, France: collaborator
• Programme hospitalier de recherche clinique, France: collaborator

Study Sites (36)

Centre Hospital-Universitaire Hôpital Nord

Amiens, 80054, France

ACTIVE NOT RECRUITING

Centre Hospitalier-Universitaire

Angers, 49933, France

ACTIVE NOT RECRUITING

Centre Hospitalier Régional Universitaire Hôpital Saint-Jacques

Besançon, 25030, France

ACTIVE NOT RECRUITING

Groupe hospitalier Pellegrin

Bordeaux, 33076, France

ACTIVE NOT RECRUITING

Centre Hospitalier Universaitaire Hôpital Côte de Nacre

Caen, 14033, France

ACTIVE NOT RECRUITING

Centre Hospitalier Universitaire Hôpial Hôtel Dieu

Clermont-Ferrand, 63003, France

ACTIVE NOT RECRUITING

Centre Hospitalier Universaitaire hôpital d'enfants

Dijon, 21000, France

ACTIVE NOT RECRUITING

Hôpital La Tronche

Grenoble, 38043, France

ACTIVE NOT RECRUITING

Centre Oscar Lambret

Lille, 59020, France

ACTIVE NOT RECRUITING

Hôpital Jeanne De Flandre

Lille, 59037, France

ACTIVE NOT RECRUITING

Hôpital de la mère et de l'enfant

Limoges, 87042, France

ACTIVE NOT RECRUITING

Institut d'Hématologie et Oncologie Pédiatrique

Lyon, 69008, France

ACTIVE NOT RECRUITING

Centre Régional de Lutte Contre le Cancer Centre Léon Bérard

Lyon, 69373, France

ACTIVE NOT RECRUITING

Hôpital d'Enfants de Margency (HEM) Croix Rouge Française

Margency, 95580, France

ACTIVE NOT RECRUITING

AP-HM Hôpital de la Timone

Marseille, 13385, France

ACTIVE NOT RECRUITING

Hôpital Arnaud De Villeneuve

Montpellier, 34295, France

ACTIVE NOT RECRUITING

Centre Hospitalier Universaitaire Hôpital mère-enfant

Nantes, 44093, France

ACTIVE NOT RECRUITING

Centre Antoine Lacassagne

Nice, 06189, France

RECRUITING

GCS Hôpitaux pédiatriques Centre Hospitalier Universitaire Lenval

Nice, 06200, France

ACTIVE NOT RECRUITING

Institut Curie

Paris, 75248, France

RECRUITING

Hôpital Armand Trousseau

Paris, 75571, France

ACTIVE NOT RECRUITING

CHRU de Poitiers La Miletrie

Poitiers, 86021, France

ACTIVE NOT RECRUITING

Institut Jean Godinot

Reims, 51056, France

RECRUITING

Centre Hospitalier Universitaire de Reims Hôpital Maison Blanche

Reims, 51090, France

ACTIVE NOT RECRUITING

Centre Hospitalier Universitaire Hôpital Sud

Rennes, 35203, France

ACTIVE NOT RECRUITING

Hôpital Charles-Nicolle

Rouen, 76038, France

ACTIVE NOT RECRUITING

Centre Hospitalier Universitaire Hôpital Nord

Saint-Etienne, 42055, France

ACTIVE NOT RECRUITING

Centre René Gauducheau de Nantes Atlantique

Saint-Herblain, 44805, France

ACTIVE NOT RECRUITING

Centre Hospitalier de Saintonge

Saintes, 17108, France

ACTIVE NOT RECRUITING

Hôpital Hautepierre

Strasbourg, 67098, France

ACTIVE NOT RECRUITING

Institut Claudius Regaud

Toulouse, 31052, France

RECRUITING

Hôpital des Enfants

Toulouse, 31059, France

ACTIVE NOT RECRUITING

Hôpital Clocheville

Tours, 37000, France

ACTIVE NOT RECRUITING

Hôpital Brabois enfants CHU de Nancy

Vandœuvre-lès-Nancy, 54500, France

ACTIVE NOT RECRUITING

Centre Régional de Lutte Contre le Cancer de Lorraine ALEXIS VAUTRIN

Vandœuvre-lès-Nancy, 54511, France

ACTIVE NOT RECRUITING

Institut Gustave Roussy

Villejuif, 94805, France

RECRUITING

Related Publications (31)

• 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.

  PMID: 15899626 BACKGROUND

• 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 RESULT

• 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.

  PMID: 22284034 RESULT

• 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.

  PMID: 21596770 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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.

  PMID: 18262102 RESULT

• 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.

  PMID: 17602088 RESULT

• 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.

  PMID: 17013899 RESULT

• 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.

  PMID: 16965909 RESULT

• 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.

  PMID: 15625374 RESULT

• 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.

  PMID: 15054872 RESULT

• 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.

  PMID: 14566829 RESULT

• 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.

  PMID: 14556931 RESULT

• 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.

  PMID: 10597762 RESULT

• 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.

  PMID: 10206309 RESULT

• 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.

  PMID: 9766556 RESULT

• 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.

  PMID: 9663598 RESULT

• 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.

  PMID: 7648361 RESULT

• 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.

  PMID: 15162142 RESULT

• 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.

  PMID: 16989913 RESULT

• 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.

  PMID: 9886702 RESULT

• 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.

  PMID: 1558799 RESULT

• 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.

  PMID: 2736215 RESULT

• 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.

  PMID: 2930714 RESULT

• 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.

  PMID: 2900383 RESULT

• 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.

  PMID: 22921663 RESULT

• 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.

  PMID: 26327481 DERIVED

Related Links

• Center for research in epidemiology and population Health - U1018 Inserm

Biospecimen

Retention: SAMPLES WITH DNA

saliva and blood samples (under another protocol)

Study Officials

• Florent F. de Vathaire, Ph.D.

  Institut National de la Santé Et de la Recherche Médicale, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Florent F. de Vathaire, Ph.D

CONTACT

florent.devathaire@igr.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2012
• First Posted: June 15, 2012
• Study Start: November 1, 2011
• Study Completion (Estimated): November 1, 2031
• Last Updated: October 10, 2012

Record last verified: 2012-10

Locations

FR (36)