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

Not Applicable

• Conditions: Leukaemia During Childhood or Adolescence
• Interventions: Biological: blood samples

• Registration Number: NCT01756599
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-20
• Study First Submitted QC: 2012-12-20
• Study First Posted: 2012-12-27
• Status Verified: 2015-09
• Last Update Submitted: 2015-10-16
• Last Update Posted: 2015-10-19
• Primary Completion: 2022-12
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2900

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
leukaemia during childhood or adolescence	blood samples	-

Primary Outcome Measures

Name	Time	Method
the data (medical, socio-economic, behavioral, environmental…) of the medium and long-term outcome of a cohort of patients treated for childhood acute leukemia	10 years

Secondary Outcome Measures

Name	Time	Method
The impact of the mortality / survival of this troop of patients, remote of the treatment of the leukaemia of the childhood.	10 years

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France