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Childhood Solid TumorFCCSSNCT01620372

French Childhood Cancer Survivor Study

An observational study of Childhood Solid Tumor, run by Institut National de la Santé Et de la Recherche Médicale, France at 36 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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… Read more about this study

Who is it for?
Ages Up to 18 years
Conditions the study is for
Childhood Solid Tumor
How many people
18,000 participants
Where
36 sitesFrance
Study dates
15 Nov 2011to 15 Nov 2031
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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.

Who may be able to join

  • 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)

Who cannot join

  • Leukaemia cases

Trial locations and contacts

36 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Florent F. de Vathaire, Ph.D contact

florent.devathaire@igr.fr

36 sites in 1 country

France36 sites, 5 recruiting

  • Centre Hospital-Universitaire Hôpital Nord

    Amiens, 80054

    Active, not recruiting

  • Centre Hospitalier-Universitaire

    Angers, 49933

    Active, not recruiting

  • Centre Hospitalier Régional Universitaire Hôpital Saint-Jacques

    Besançon, 25030

    Active, not recruiting

  • Groupe hospitalier Pellegrin

    Bordeaux, 33076

    Active, not recruiting

  • Centre Hospitalier Universaitaire Hôpital Côte de Nacre

    Caen, 14033

    Active, not recruiting

  • Centre Hospitalier Universitaire Hôpial Hôtel Dieu

    Clermont-Ferrand, 63003

    Active, not recruiting

  • Centre Hospitalier Universaitaire hôpital d'enfants

    Dijon, 21000

    Active, not recruiting

  • Hôpital La Tronche

    Grenoble, 38043

    Active, not recruiting

  • Centre Oscar Lambret

    Lille, 59020

    Active, not recruiting

  • Hôpital Jeanne De Flandre

    Lille, 59037

    Active, not recruiting

  • Hôpital de la mère et de l'enfant

    Limoges, 87042

    Active, not recruiting

  • Institut d'Hématologie et Oncologie Pédiatrique

    Lyon, 69008

    Active, not recruiting

  • Centre Régional de Lutte Contre le Cancer Centre Léon Bérard

    Lyon, 69373

    Active, not recruiting

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

    Margency, 95580

    Active, not recruiting

  • AP-HM Hôpital de la Timone

    Marseille, 13385

    Active, not recruiting

  • Hôpital Arnaud De Villeneuve

    Montpellier, 34295

    Active, not recruiting

  • Centre Hospitalier Universaitaire Hôpital mère-enfant

    Nantes, 44093

    Active, not recruiting

  • Centre Antoine Lacassagne

    Nice, 06189

    Recruiting

  • GCS Hôpitaux pédiatriques Centre Hospitalier Universitaire Lenval

    Nice, 06200

    Active, not recruiting

  • Institut Curie

    Paris, 75248

    Recruiting

  • Hôpital Armand Trousseau

    Paris, 75571

    Active, not recruiting

  • CHRU de Poitiers La Miletrie

    Poitiers, 86021

    Active, not recruiting

  • Institut Jean Godinot

    Reims, 51056

    Recruiting

  • Centre Hospitalier Universitaire de Reims Hôpital Maison Blanche

    Reims, 51090

    Active, not recruiting

  • Centre Hospitalier Universitaire Hôpital Sud

    Rennes, 35203

    Active, not recruiting

  • Hôpital Charles-Nicolle

    Rouen, 76038

    Active, not recruiting

  • Centre Hospitalier Universitaire Hôpital Nord

    Saint-Etienne, 42055

    Active, not recruiting

  • Centre René Gauducheau de Nantes Atlantique

    Saint-Herblain, 44805

    Active, not recruiting

  • Centre Hospitalier de Saintonge

    Saintes, 17108

    Active, not recruiting

  • Hôpital Hautepierre

    Strasbourg, 67098

    Active, not recruiting

  • Institut Claudius Regaud

    Toulouse, 31052

    Recruiting

  • Hôpital des Enfants

    Toulouse, 31059

    Active, not recruiting

  • Hôpital Clocheville

    Tours, 37000

    Active, not recruiting

  • Hôpital Brabois enfants CHU de Nancy

    Vandœuvre-lès-Nancy, 54500

    Active, not recruiting

  • Centre Régional de Lutte Contre le Cancer de Lorraine ALEXIS VAUTRIN

    Vandœuvre-lès-Nancy, 54511

    Active, not recruiting

  • Institut Gustave Roussy

    Villejuif, 94805

    Recruiting

Other trials in France

About this study

Official title: 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.

Read the detailed 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.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01620372
Study groupRoleWhat they receive
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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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,...)

    Measured: by time since diagnosis of solid childhood cancer

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2012 (estimated)
  2. Study start15 Nov 2011
  3. Primary completion15 Nov 2031 (estimated)
  4. Study completion15 Nov 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
18,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01620372
Sponsor's protocol ID
C12-25
Acronym
FCCSS
Status last verified
Jul 2026
First submitted
13 Jun 2012
Last updated
30 Jul 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 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.2011.05.069.

    PubMed 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/awr071.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 19386434

  • 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.

    PubMed 18262102

  • 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.

    PubMed 17602088

  • 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.

    PubMed 17013899

  • 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.

    PubMed 16965909

  • 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.

    PubMed 15625374

  • 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.

    PubMed 15054872

  • 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.

    PubMed 14566829

Questions about this trial

What is this clinical trial studying?

An observational study of Childhood Solid Tumor, run by Institut National de la Santé Et de la Recherche Médicale, France at 36 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Florent F. de Vathaire, Ph.D (florent.devathaire@igr.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All health events of interest (time frame: by time since diagnosis of solid childhood cancer). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01620372, which also lists 32 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.

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