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: Unknown
• Conditions: Solid Tumor in Children
• Intervention / Treatment: Other: The WISC-IV; Other: The CMS (CHILD MEMORY SCALE); Other: CONNERS; Other: BRIEF; Other: PEDS-QL; Other: State Trait Anxiety Inventory; Other: Child Depression Inventory

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

Contacts and Locations

• Study Contact: Name: Christelle DUFOUR, MD; Phone Number: +33 0142114211; 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 0142114211; Email: christelle.dufour@gustaveroussy.fr

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patient aged 6 to 16 years and 11 months during the study period (2014-2016)

Description

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

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-IV; The WISC-IV (Weschler, 2003) which is measured with several indices: A Verbal Understanding Index (VUI), which comprehensively assesses the child's verbal skills; Perceptual reasoning index (PRI), which assesses isuoperceptive and visuo-practical capacities; An index of working memory (IWM), which assesses the child's ability to do several things at the same time (double-tasks); A rate of treatment index (RTI) that assesses grapho-motor speed; Other: The CMS (CHILD MEMORY SCALE); It is an evaluation scale of episodic memory with an immediate recall (after reading the story to remember) and a delayed recall (25-35 min after); Other: CONNERS; The "CONNERS" which allows the assessment of attentional skills through a questionnaire that will be completed by parents; Other: BRIEF; The "BRIEF" which is an inventory of behavioral evaluation of executive functions completed by parents and which makes it possible to determine if the child has, for example, difficulties of organization, planning or behavioral regulation.; Other: PEDS-QL; The "PEDS-QL quality of life" 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: State Trait Anxiety Inventory; The State Trait Anxiety Inventory (STAI), which assesses the anxiety of the child (trait and situational anxiety).; Other: Child Depression Inventory; The Child Depression Inventory (CDI) assessing any signs of depression in the child.
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-IV; The WISC-IV (Weschler, 2003) which is measured with several indices: A Verbal Understanding Index (VUI), which comprehensively assesses the child's verbal skills; Perceptual reasoning index (PRI), which assesses isuoperceptive and visuo-practical capacities; An index of working memory (IWM), which assesses the child's ability to do several things at the same time (double-tasks); A rate of treatment index (RTI) that assesses grapho-motor speed; Other: The CMS (CHILD MEMORY SCALE); It is an evaluation scale of episodic memory with an immediate recall (after reading the story to remember) and a delayed recall (25-35 min after); Other: CONNERS; The "CONNERS" which allows the assessment of attentional skills through a questionnaire that will be completed by parents; Other: BRIEF; The "BRIEF" which is an inventory of behavioral evaluation of executive functions completed by parents and which makes it possible to determine if the child has, for example, difficulties of organization, planning or behavioral regulation.; Other: PEDS-QL; The "PEDS-QL quality of life" 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: State Trait Anxiety Inventory; The State Trait Anxiety Inventory (STAI), which assesses the anxiety of the child (trait and situational anxiety).; Other: Child Depression Inventory; The Child Depression Inventory (CDI) assessing any signs of depression in the child.
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-IV; The WISC-IV (Weschler, 2003) which is measured with several indices: A Verbal Understanding Index (VUI), which comprehensively assesses the child's verbal skills; Perceptual reasoning index (PRI), which assesses isuoperceptive and visuo-practical capacities; An index of working memory (IWM), which assesses the child's ability to do several things at the same time (double-tasks); A rate of treatment index (RTI) that assesses grapho-motor speed; Other: The CMS (CHILD MEMORY SCALE); It is an evaluation scale of episodic memory with an immediate recall (after reading the story to remember) and a delayed recall (25-35 min after); Other: CONNERS; The "CONNERS" which allows the assessment of attentional skills through a questionnaire that will be completed by parents; Other: BRIEF; The "BRIEF" which is an inventory of behavioral evaluation of executive functions completed by parents and which makes it possible to determine if the child has, for example, difficulties of organization, planning or behavioral regulation.; Other: PEDS-QL; The "PEDS-QL quality of life" 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: State Trait Anxiety Inventory; The State Trait Anxiety Inventory (STAI), which assesses the anxiety of the child (trait and situational anxiety).; Other: Child Depression Inventory; The Child Depression Inventory (CDI) assessing any signs of depression in the child.

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 (Anticipated): October 1, 2019
• Study Completion (Anticipated): October 1, 2019

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): August 1, 2018
• Last Update Submitted That Met QC Criteria: July 24, 2018
• Last Verified: July 1, 2018

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