French Childhood Cancer Survivor Study

Childhood Solid Tumor Clinical Trial

— FCCSS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01620372
• Other study ID #: C12-25
• Status: Recruiting
• Phase: N/A
• First received: June 13, 2012
• Last updated: October 8, 2012
• Start date: November 2011
• Est. completion date: November 2031

Study information

• Verified date: October 2012
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: Florent F. de Vathaire, Ph.D
• Email: florent.devathaire[@]igr.fr
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18000
• Est. completion date: November 2031
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Childhood Solid Tumor

Locations

Country	Name	City	State
France	Centre Hospital-Universitaire Hôpital Nord	Amiens
France	Centre Hospitalier-Universitaire	Angers
France	Centre Hospitalier Régional Universitaire Hôpital Saint-Jacques	Besançon
France	Groupe hospitalier Pellegrin	Bordeaux
France	Centre Hospitalier Universaitaire Hôpital Côte de Nacre	Caen
France	Centre Hospitalier Universitaire Hôpial Hôtel Dieu	Clermont Ferrand
France	Centre Hospitalier Universaitaire hôpital d'enfants	Dijon
France	Hôpital La Tronche	Grenoble
France	Centre Oscar Lambret	Lille
France	Hôpital Jeanne De Flandre	Lille
France	Hôpital de la mère et de l'enfant	Limoges
France	Centre Régional de Lutte Contre le Cancer Centre Léon Bérard	Lyon
France	Institut d'Hématologie et Oncologie Pédiatrique	Lyon
France	Hôpital d'Enfants de Margency (HEM) Croix Rouge Française	Margency
France	AP-HM Hôpital de la Timone	Marseille
France	Hôpital Arnaud De Villeneuve	Montpellier
France	Centre Hospitalier Universaitaire Hôpital mère-enfant	Nantes
France	Centre Antoine Lacassagne	Nice
France	GCS Hôpitaux pédiatriques Centre Hospitalier Universitaire Lenval	Nice
France	Hôpital Armand Trousseau	Paris
France	Institut Curie	Paris
France	CHRU de Poitiers La Miletrie	Poitiers
France	Centre Hospitalier Universitaire de Reims Hôpital Maison Blanche	Reims
France	Institut Jean Godinot	Reims
France	Centre Hospitalier Universitaire Hôpital Sud	Rennes
France	Hôpital Charles-Nicolle	Rouen
France	Centre Hospitalier Universitaire Hôpital Nord	Saint Etienne
France	Centre René Gauducheau de Nantes Atlantique	Saint-Herblain
France	Centre Hospitalier de Saintonge	Saintes
France	Hôpital Hautepierre	Strasbourg
France	Hôpital des Enfants	Toulouse
France	Institut Claudius Regaud	Toulouse
France	Hôpital Clocheville	Tours
France	Centre Régional de Lutte Contre le Cancer de Lorraine ALEXIS VAUTRIN	Vandoeuvre-les-Nancy
France	Hôpital Brabois enfants CHU de Nancy	Vandoeuvre-les-Nancy
France	Institut Gustave Roussy	Villejuif

Sponsors (4)

Lead Sponsor	Collaborator
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

Country where clinical trial is conducted

France, 

References & Publications (30)

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 — View Citation

de Vathaire F, François 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):7 — View Citation

de Vathaire F, François 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- — View Citation

de Vathaire F, François 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. — View Citation

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, Bonaïti C. Thyroid carcinomas after irradiation for a fir — View Citation

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, Eschwège F, Chavaudra J, Lemerle J. Second malignant ne — View Citation

de Vathaire F, Schweisguth O, Rodary C, François 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. — View Citation

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 A — View Citation

Diallo I, Haddy N, Adjadj E, Samand A, Quiniou E, Chavaudra J, Alziar I, Perret N, Guérin S, Lefkopoulos D, de Vathaire F. Frequency distribution of second solid cancer locations in relation to the irradiated volume among 115 patients treated for childhoo — View Citation

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. Review. French. — View Citation

Guérin 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 — View Citation

Guérin 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 — View Citation

Guérin S, Hawkins M, Shamsaldin A, Guibout C, Diallo I, Oberlin O, Brugières 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. — View Citation

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 Cli — View Citation

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 f — View Citation

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 adeno — View Citation

Haddy N, Le Deley MC, Samand A, Diallo I, Guérin 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):2757-6 — View Citation

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 fo — View Citation

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, Eschwège F, Chavaudra J, Lemerle J. Radiation dose, chemotherapy and risk of osteosarcoma — View Citation

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 — View Citation

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 — View Citation

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 — View Citation

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. Review. French. — View Citation

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. B — View Citation

Rubino C, Adjadj E, Guérin 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):7 — View Citation

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. — View Citation

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 o — View Citation

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 — View Citation

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 sol — View Citation

Tukenova M, Guibout C, Oberlin O, Doyon F, Mousannif A, Haddy N, Guérin 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 chil — View Citation

* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

External Links

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