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

G

Gustave Roussy

Status

Unknown

Conditions

Solid Tumor in Children

Treatments

Other: The CMS (CHILD MEMORY SCALE)
Other: CONNERS
Other: State Trait Anxiety Inventory
Other: BRIEF
Other: Child Depression Inventory
Other: PEDS-QL
Other: The WISC-IV

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 (2014-2016)
  • 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 WISC-IV
Other: PEDS-QL
Other: Child Depression Inventory
Other: BRIEF
Other: State Trait Anxiety Inventory
Other: CONNERS
Other: The CMS (CHILD MEMORY SCALE)
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 WISC-IV
Other: PEDS-QL
Other: Child Depression Inventory
Other: BRIEF
Other: State Trait Anxiety Inventory
Other: CONNERS
Other: The CMS (CHILD MEMORY SCALE)
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 WISC-IV
Other: PEDS-QL
Other: Child Depression Inventory
Other: BRIEF
Other: State Trait Anxiety Inventory
Other: CONNERS
Other: The CMS (CHILD MEMORY SCALE)

Trial contacts and locations

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Central trial contact

Christelle DUFOUR, MD

Data sourced from clinicaltrials.gov

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