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Recruiting NCT03609112

Neurocognitive Risks in Children With Solid Tumors

— Observational Solid Tumor in Children

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: The WISC-V, The NEPSY-II, The Child Executive Function Evaluation Battery CEF, The "CONNERS 3 long version".
Who it may be relevant to
Registry conditions: Solid Tumor in Children. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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)

Interventions

  • Other The WISC-V
    The WISC-V (Weschler, 2016) which is measured with several indices: Verbal Comprehension Index (VCI), Visual Spatial Index (VSI), Working Memory Index (WMI), Fluid Reasoning Index (FRI), Processing Speed Index (PSI), and Full Scale IS (FSIQ).
  • Other The NEPSY-II
    The NEPSY-II (Korkman et al., 2012). The Narrative Memory subtest is designed to assess verbal memory using organised language material.
  • Other The Child Executive Function Evaluation Battery CEF
    The Child Executive Function Evaluation Battery CEF (Roy et al., 2021), which aims to evaluate the four main components of executive function (inhibition, working memory, flexibility and planning).
  • Other The "CONNERS 3 long version"
    The " CONNERS 3 long version " (Conners, 2008), which assesses attentional skills by means of a questionnaire to be completed by parents.
  • Other The "BRIEF"
    The 'BRIEF' (Gioia et al., 2013; parent version, teacher version), which is a behavioural evaluation inventory of executive functions completed by parents and teachers and which makes it possible to determine whether the child has, for example, difficulties with organisation, planning or behavioural regulation.
  • Other The "PEDS-QL quality of life"
    The "PEDS-QL quality of life" (Tessier et al., 2009) that will be completed by the parents and the patient concerns the day to- day functioning of the child (in school, relationships to others, physical abilities and emotional state).
  • Other The 'fatigue' version of the PEDS-QL (Tessier et al., 2009: parent and child-adolescent version for the brain tumour cohort)
    The 'fatigue' version of the PEDS-QL (Tessier et al., 2009: parent and child-adolescent version for the brain tumour cohort) which assesses fatigue in everyday life.
  • Other The Family Functioning Inventory FAD)
    The Family Functioning Inventory FAD (Speranza et al., 2006) is used to assess the family functioning of the child and his/her family. The short version is used as an indicator of general functioning.
  • Other The 'fatigue' version of the PEDS-QL (Tessier et al., 2009: child version for the extra-cerebral tumour cohort)
    The 'fatigue' version of the PEDS-QL (Tessier et al., 2009: child version for the extra-cerebral tumour cohort) which assesses fatigue in everyday life.

Primary outcome measures

  • Descriptive analysis of possible neurocognitive deficits according to the pathology and treatments received. [Time frame: Up to 60 months]
  • Univariate analysis to identify risk factors related to cognitive disorders. [Time frame: Up to 60 months]
  • Multiple regression analysis to determine the most significant risk factors and examine the interactions between these factors. [Time frame: Up to 60 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Gustave Roussy — Villejuif

Identifiers

NCT: NCT03609112 · 2014-A00924-43 · 2014/2127

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗