Prevalence of Psychocognitive Impairments in Adolescents Surviving Childhood Leukemia : LEA-PsyCog (LEA-PsyCog)

November 16, 2015 updated by: Assistance Publique Hopitaux De Marseille

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Marseille, France, 13354
        • Recruiting
        • Assistance Publique Hopitaux de Marseille
        • Contact:
        • Principal Investigator:
          • david dafonseca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: group psychopathological
Other: neuropsychological evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diagnosis psychopathological
Time Frame: 36 months
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

December 3, 2012

First Submitted That Met QC Criteria

December 3, 2012

First Posted (Estimate)

December 5, 2012

Study Record Updates

Last Update Posted (Estimate)

November 17, 2015

Last Update Submitted That Met QC Criteria

November 16, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-A01129-34
  • 2012-29 (Other Identifier: AP HM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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