Prevalence of Psychocognitive Impairments in Adolescents Surviving Childhood Leukemia : LEA-PsyCog (LEA-PsyCog)
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|ClinicalTrials.gov Identifier: NCT01741662|
Recruitment Status : Unknown
Verified November 2015 by Assistance Publique Hopitaux De Marseille.
Recruitment status was: Recruiting
First Posted : December 5, 2012
Last Update Posted : November 17, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Adolescents Surviving Childhood Leukemia LEA||Other: neuropsychological evaluation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||170 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prevalence of Psychocognitive Impairments in Adolescents Surviving Childhood Leukemia : LEA-PsyCog|
|Study Start Date :||July 2013|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||June 2016|
Other: neuropsychological evaluation
- Diagnosis psychopathological [ Time Frame: 36 months ]
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): NCT01741662
|Contact: david da email@example.com|
|Assistance Publique Hopitaux de Marseille||Recruiting|
|Marseille, France, 13354|
|Contact: david dafonseca firstname.lastname@example.org|
|Principal Investigator: david dafonseca|
|Study Director:||BERNARD BELAIGUES||Assistance Publique Hopitaux De Marseille|