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

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)

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor in Children
• Intervention / Treatment: Other: The WISC-V; Other: The NEPSY-II; Other: The Child Executive Function Evaluation Battery CEF; Other: The "CONNERS 3 long version"; Other: The "BRIEF"; Other: The "PEDS-QL quality of life"; Other: The 'fatigue' version of the PEDS-QL (Tessier et al., 2009: parent and child-adolescent version for the brain tumour cohort); 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)

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Christelle DUFOUR, MD; Phone Number: +33 (0)1 42 11 42 11; Email: christelle.dufour@gustaveroussy.fr

Study Locations

• France
  • Val De Marne
    • Villejuif, Val De Marne, France, 94805
      • Recruiting
      • Gustave Roussy
      • Contact: Christelle DUFOUR, MD; Phone Number: +33 (0)1 42 11 42 11; Email: christelle.dufour@gustaveroussy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient aged 6 to 16 years and 11 months during the study period

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients treated for a brain tumor; 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.	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.
Patients treated for a non-cerebral tumor; 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.	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 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 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.
Patients who received Methotrexate; 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.	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 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 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: July 24, 2018
• First Submitted That Met QC Criteria: July 24, 2018
• First Posted (Actual): August 1, 2018

Study Record Updates

• Last Update Posted (Actual): December 13, 2024
• Last Update Submitted That Met QC Criteria: December 10, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 2014-A00924-43; 2014/2127 (Other Identifier: CSET number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No