Neurocognitive Risks in Children With Solid Tumors (RISK-N)

Gustave Roussy

Status: Enrolling

Conditions: Solid Tumor in Children

Treatments: Other: The "BRIEF"; Other: The 'fatigue' version of the PEDS-QL (Tessier et al., 2009: parent and child-adolescent version for the brain tumour cohort); Other: The NEPSY-II; Other: The WISC-V; Other: The Family Functioning Inventory FAD); Other: The 'fatigue' version of the PEDS-QL (Tessier et al., 2009: child version for the extra-cerebral tumour cohort); Other: The "CONNERS 3 long version"; Other: The "PEDS-QL quality of life"; Other: The Child Executive Function Evaluation Battery CEF

Study type: Observational

Funder types: Other

Identifiers

NCT03609112

2014/2127 (Other Identifier)

2014-A00924-43

Details and patient eligibility

About

The survival rate of children with cancer has improved significantly in recent years thanks to the progress of different therapies. The neurocognitive sequelae related to treatments and illness are more or less well known. Four factors seem to be associated with neurocognitive sequelae: treatment, the tumor itself, environmental factors like the socio-economic status of parents and biological factors.

Main purpose of the study is to establish a score to assess the risk of neurocognitive sequelae in these children based on these factors (treatment, tumor, and environmental factors)

Enrollment: 1,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient aged 6 to 16 years and 11 months during the study period
• Type of pathology: solid tumor
• Place of treatment and follow-up: Gustave Roussy
• Minimum time from the end of the initial treatment:
• For patients who have not received treatment with methotrexate: 6 months
• For patients being treated with methotrexate: none
• Obtaining the non-opposition of parents / legal representatives
• Affiliation to a social security scheme.

Exclusion criteria

• Patients with other pathologies associated with mental retardation (autism, genetic syndrome ...)
• Patients lost to follow-up
• Deceased patients
• Patients treated for a pathology whose prognosis is involved in the very short term (infiltrating glioma of the brainstem, recurrence of the pathology during treatment)
• Non-French speaking patients

Trial design

1,000 participants in 3 patient groups

Patients treated for a brain tumor

Description:

As part of their usual follow-up, these patients have neuropsychological evaluations following their treatment. A complete neuropsychological evaluation will therefore be performed as part of their usual follow-up during the inclusion period of this study and only the data from this evaluation will be taken into account for the statistical analysis of this study.

Treatment:

Other: The Child Executive Function Evaluation Battery CEF

Other: The "PEDS-QL quality of life"

Other: The "CONNERS 3 long version"

Other: The Family Functioning Inventory FAD)

Other: The NEPSY-II

Other: The WISC-V

Other: The 'fatigue' version of the PEDS-QL (Tessier et al., 2009: parent and child-adolescent version for the brain tumour cohort)

Other: The "BRIEF"

Patients treated for a non-cerebral tumor

Description:

A single neuropsychological assessment will be proposed to these patients after the end of treatment and during the inclusion period of this study. This evaluation will be carried out during a visit to Gustave Roussy as part of their usual follow-up. If on the occasion of this evaluation, cognitive disorders or psychological disorders were highlighted, a neuropsychological and / or psychological follow-up would be proposed.

Treatment:

Other: The Child Executive Function Evaluation Battery CEF

Other: The "CONNERS 3 long version"

Other: The 'fatigue' version of the PEDS-QL (Tessier et al., 2009: child version for the extra-cerebral tumour cohort)

Other: The Family Functioning Inventory FAD)

Other: The WISC-V

Other: The "BRIEF"

Patients who received Methotrexate

Description:

Methotrexate is used in the treatment of certain brain tumors as in that of non-cerebral tumors. Some of these patients, particularly those who have had neurological complications with methotrexate, will already have longitudinal neuropsychological follow-up as part of their usual follow-up. For these patients, only one complete neuropsychological assessment will be performed during the inclusion period and will be considered for statistical analysis. For patients in the course of treatment with methotrexate, during the period of inclusion of this study, a longitudinal follow-up will be carried out with neuropsychological evaluations close and successive at the time of their coming to Gustave Roussy within the usual framework of their care.

Treatment:

Other: The Child Executive Function Evaluation Battery CEF

Other: The "CONNERS 3 long version"

Other: The 'fatigue' version of the PEDS-QL (Tessier et al., 2009: child version for the extra-cerebral tumour cohort)

Other: The Family Functioning Inventory FAD)

Other: The WISC-V

Other: The "BRIEF"