Multi-centre Prospective Cohort of Childhood Leukaemia: Determinants of Health and Quality of Life of the Patients After Treatment for an Acute Leukaemia During Childhood or Adolescence - LEA
Primary Purpose
Leukaemia During Childhood or Adolescence
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood samples
Sponsored by

About this trial
This is an interventional health services research trial for Leukaemia During Childhood or Adolescence
Eligibility Criteria
Inclusion Criteria:
- Respect for the criteria of inclusion in the troop;
- 24-month-old Survivor of recoil(drop) with regard to(compared with) the diagnosis for the Leukaemia Aiguës Myéloblastiques (LAM) and Leukaemia Aiguës Lymphoblastiques ( LAL) transplanted in 1st complete forgiveness; or in 48 months of recoil(drop) with regard to(compared with) the diagnosis for the LAL not transplanted in first complete forgiveness;
- Having given his(her,its) agreement to participate in the study;
- Authorized to participate in the study by the parents(relatives) or the legal representatives, for any minor subject; in the particular case of a minor(miner) become major during the follow-up, a grown-up consent will be collected(taken in).
Exclusion Criteria:
- Non compliance with the criteria of inclusion beforehand quoted,
- Initial Treatment(Processing) realized except 9 participating centers, even in case of moving in in the geographical zones covered by these centers during the phase of treatment(processing) or in the course of follow-up.
Sites / Locations
- Assistance Publique Hopitaux de MarseilleRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
leukaemia during childhood or adolescence
Arm Description
Outcomes
Primary Outcome Measures
the data (medical, socio-economic, behavioral, environmental…) of the medium and long-term outcome of a cohort of patients treated for childhood acute leukemia
Secondary Outcome Measures
The impact of the mortality / survival of this troop of patients, remote of the treatment of the leukaemia of the childhood.
Full Information
NCT ID
NCT01756599
First Posted
December 20, 2012
Last Updated
October 16, 2015
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT01756599
Brief Title
Multi-centre Prospective Cohort of Childhood Leukaemia: Determinants of Health and Quality of Life of the Patients After Treatment for an Acute Leukaemia During Childhood or Adolescence - LEA
Official Title
Multi-centre Prospective Cohort of Childhood Leukaemia: Determinants of Health and Quality of Life of the Patients After Treatment for an Acute Leukaemia During Childhood or Adolescence - LEA
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Regular advances in cancer treatment have dramatically improved the prognosis of children and adolescents with acute leukemia (AL), raising with a great acuity the problem of the late physical side effects, social integration, quality of life of the patients and their family as well as identification of the determinants of these outcomes. Large nationwide and international cohorts developed in general population (I4C, EPIC ELF…) are restricted to the study of childhood cancers occurrence. In addition, the national registries (French, European) of childhood cancers are designed to evaluate incidence and mortality, but not to produce individual detailed data on the follow-up and outcome of these children. Answering these questions supposes a comprehensive multidisciplinary approach resting on prospective cohorts of cancer survivors, specifically exploring the outcome of these children. These cohorts allow to identify prognostic factors of the health condition and social integration, and to propose adapted strategies of follow-up. The Childhood Cancer Survivor Study (CCSS), which remains the most important study, only concerns the North-American populations and rests on a self-reported follow-up assessment. In France, the LEA study, initiated in 2004 could answer some of these questions, but the representativeness and the size of the population (study initially limited to two areas PACA-Corsica and Lorraine) remain insufficient to study uncommon events. Similar approaches are conducted in Europe trough the broad collaborative Pancare network, to which the LEA program is associated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukaemia During Childhood or Adolescence
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2900 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
leukaemia during childhood or adolescence
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
blood samples
Primary Outcome Measure Information:
Title
the data (medical, socio-economic, behavioral, environmental…) of the medium and long-term outcome of a cohort of patients treated for childhood acute leukemia
Time Frame
10 years
Secondary Outcome Measure Information:
Title
The impact of the mortality / survival of this troop of patients, remote of the treatment of the leukaemia of the childhood.
Time Frame
10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Respect for the criteria of inclusion in the troop;
24-month-old Survivor of recoil(drop) with regard to(compared with) the diagnosis for the Leukaemia Aiguës Myéloblastiques (LAM) and Leukaemia Aiguës Lymphoblastiques ( LAL) transplanted in 1st complete forgiveness; or in 48 months of recoil(drop) with regard to(compared with) the diagnosis for the LAL not transplanted in first complete forgiveness;
Having given his(her,its) agreement to participate in the study;
Authorized to participate in the study by the parents(relatives) or the legal representatives, for any minor subject; in the particular case of a minor(miner) become major during the follow-up, a grown-up consent will be collected(taken in).
Exclusion Criteria:
Non compliance with the criteria of inclusion beforehand quoted,
Initial Treatment(Processing) realized except 9 participating centers, even in case of moving in in the geographical zones covered by these centers during the phase of treatment(processing) or in the course of follow-up.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
pascal auquier
Email
pascal.auquier@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urielle DESALBRES
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
pascal AUQUIER
Organizational Affiliation
AP HM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PASCAL AUQUIER
Email
pascal.auquier@ap-hm.fr
12. IPD Sharing Statement
Citations:
PubMed Identifier
29351982
Citation
Oudin C, Berbis J, Bertrand Y, Vercasson C, Thomas F, Chastagner P, Ducassou S, Kanold J, Tabone MD, Paillard C, Poiree M, Plantaz D, Dalle JH, Gandemer V, Thouvenin S, Sirvent N, Saultier P, Beliard S, Leverger G, Baruchel A, Auquier P, Pannier B, Michel G. Prevalence and characteristics of metabolic syndrome in adults from the French childhood leukemia survivors' cohort: a comparison with controls from the French population. Haematologica. 2018 Apr;103(4):645-654. doi: 10.3324/haematol.2017.176123. Epub 2018 Jan 19.
Results Reference
derived
PubMed Identifier
27515247
Citation
Saultier P, Auquier P, Bertrand Y, Vercasson C, Oudin C, Contet A, Plantaz D, Poiree M, Ducassou S, Kanold J, Tabone MD, Dalle JH, Lutz P, Gandemer V, Sirvent N, Thouvenin S, Berbis J, Chambost H, Baruchel A, Leverger G, Michel G. Metabolic syndrome in long-term survivors of childhood acute leukemia treated without hematopoietic stem cell transplantation: an L.E.A. study. Haematologica. 2016 Dec;101(12):1603-1610. doi: 10.3324/haematol.2016.148908. Epub 2016 Aug 11.
Results Reference
derived
PubMed Identifier
26969082
Citation
Oudin C, Auquier P, Bertrand Y, Chastagner P, Kanold J, Poiree M, Thouvenin S, Ducassou S, Plantaz D, Tabone MD, Dalle JH, Gandemer V, Lutz P, Sirvent A, Villes V, Barlogis V, Baruchel A, Leverger G, Berbis J, Michel G. Late thyroid complications in survivors of childhood acute leukemia. An L.E.A. study. Haematologica. 2016 Jun;101(6):747-56. doi: 10.3324/haematol.2015.140053. Epub 2016 Mar 11.
Results Reference
derived
Learn more about this trial
Multi-centre Prospective Cohort of Childhood Leukaemia: Determinants of Health and Quality of Life of the Patients After Treatment for an Acute Leukaemia During Childhood or Adolescence - LEA
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