Informations générales (source: ClinicalTrials.gov)
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
Interventional
N/A
Assistance Publique Hopitaux De Marseille (Voir sur ClinicalTrials)
décembre 2012
juillet 2023
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Assistance Publique Hopitaux de Marseille - 13354 - Marseille - France | PASCAL AUQUIER | Contact (sur clinicalTrials) | |||
Critères
Tous
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).
- 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).
- 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.