ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01756599
Recruitment Status : Recruiting
First Posted : December 27, 2012
Last Update Posted : October 19, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Leukaemia During Childhood or Adolescence Biological: blood samples Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2900 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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 Start Date : December 2012
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: leukaemia during childhood or adolescence Biological: blood samples



Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01756599


Contacts
Contact: pascal auquier pascal.auquier@ap-hm.fr

Locations
France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: PASCAL AUQUIER       pascal.auquier@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: Urielle DESALBRES Assistance Publique Hopitaux De Marseille
Principal Investigator: pascal AUQUIER AP HM