NCT03609112

Neurocognitive Risks in Children With Solid Tumors

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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)

Conditions

• Solid Tumor in Children

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-10-01
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2018-08-01
• Last updated: 2024-12-13

Locations

1 site across 1 country: France