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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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01756599
Enrollment
2900
Registered
2012-12-27
Start date
2012-12-31
Completion date
2023-07-31
Last updated
2015-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukaemia During Childhood or Adolescence

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.

Interventions

BIOLOGICALblood samples

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
the data (medical, socio-economic, behavioral, environmental…) of the medium and long-term outcome of a cohort of patients treated for childhood acute leukemia10 years

Secondary

MeasureTime frame
The impact of the mortality / survival of this troop of patients, remote of the treatment of the leukaemia of the childhood.10 years

Countries

France

Contacts

Primary Contactpascal auquier
pascal.auquier@ap-hm.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026