Adolescents Surviving Childhood Leukemia LEA Clinical Trial
— LEA-PsyCogOfficial title:
Prevalence of Psychocognitive Impairments in Adolescents Surviving Childhood Leukemia : LEA-PsyCog
The objective of the LEA-PsyCog project is to assess the prevalence of psychiatric disorders
and psychocognitive impairments in adolescents surviving childhood leukemia .
The second objective is to explore the complex relationships between psycocognitive
development and soiciodemodemographics data, main characteristics of leukemia, treatments,
side-effects, quality of life and characteristics of proxyies environment.
3. Materials and Methods The LEA study is based on the constitution of a multi-centric
prospective cohort in 11 university hospitals: Bordeaux, Clermont-Ferrand, Grenoble, Lyon,
Paris (Trousseau, Robert Debré, St Louis), Marseille, Montpellier, Nancy, Nice, Rennes. Are
inclued in LEA all the children diagnosed and treated for acute leukemia since January 1980
(incident and prevalent cases), surviving at month 24 for the AML and ALL grafted in
complete remission and at month 48 for the ALL not grafted in first complete remission.
The LEA Psy-Cog study rests on a sample of the LEA cohort. Are included the patients
12-17-years-old from the PACA-Corse sub-cohort (administrative district of 4 million of
people which corresponds to the Marseille and Nice centers). Patients from this two centers
are the patients with the more important length of survey, allowing us to produce a not
biaised estimation of prevalence rate. Finally, the choice of this subsample is supported by
the proximity of the Mediterranean Center for Adolescent in Marseilles, specifically
dedicated to the psychological follow-up of children suffering from cancer.
| Status | Recruiting |
| Enrollment | 170 |
| Est. completion date | June 2016 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 12 Years to 17 Years |
| Eligibility |
Inclusion Criteria: - - Age 18-year-old subordinate at the time of the diagnosis; - Diagnosis of acute(sharp) leukaemia; - Diagnosis from January, 1980; - Treatment(Processing) of the acute(sharp) leukaemia introduced in one of the inquiring centers (services(departments) specialized hematology and Clermont Ferrand's pediatric oncology, Grenoble, Lyon, Marseille, Nancy, Nancy, Nice, Paris - Robert Debré/Saint Debré/Saint Louis/Trousseau Louis/Trousseau; - Living in France; - Possessing a national insurance scheme - 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; Exclusion Criteria: - Failure to respect the criteria of inclusion beforehand quoted, - Initial Treatment(Processing) realized except 2 participating centers (Marseille, Nice), 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 |
Intervention Model: Single Group Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| France | Assistance Publique Hopitaux de Marseille | Marseille |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique Hopitaux De Marseille |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Diagnosis psychopathological | 36 months | No |