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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
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief Summary:

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Arm Intervention/treatment
group psychopathological Other: neuropsychological evaluation



Primary Outcome Measures :
  1. Diagnosis psychopathological [ Time Frame: 36 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01741662


Contacts
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Contact: david da fonseca david.dafonseca@ap-hm.fr

Locations
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France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: david dafonseca       david.dafonseca@ap-hm.fr   
Principal Investigator: david dafonseca         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: BERNARD BELAIGUES Assistance Publique Hopitaux De Marseille

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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01741662     History of Changes
Other Study ID Numbers: 2012-A01129-34
2012-29 ( Other Identifier: AP HM )
First Posted: December 5, 2012    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
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Leukemia
Neoplasms by Histologic Type
Neoplasms