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NCT Number: NCT03609112

Neurocognitive Risks in Children With Solid Tumors

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)

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Key information

Conditions

Solid Tumor in Children

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The WISC-V

Other

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).

The NEPSY-II

Other

The NEPSY-II (Korkman et al., 2012). The Narrative Memory subtest is designed to assess verbal memory using organised language material.

The Child Executive Function Evaluation Battery CEF

Other

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).

The "CONNERS 3 long version"

Other

The " CONNERS 3 long version " (Conners, 2008), which assesses attentional skills by means of a questionnaire to be completed by parents.

The "BRIEF"

Other

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.

The "PEDS-QL quality of life"

Other

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).

The 'fatigue' version of the PEDS-QL (Tessier et al., 2009: parent and child-adolescent version for the brain tumour cohort)

Other

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.

The Family Functioning Inventory FAD)

Other

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.

The 'fatigue' version of the PEDS-QL (Tessier et al., 2009: child version for the extra-cerebral tumour cohort)

Other

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 outcomes

  1. Descriptive analysis of possible neurocognitive deficits according to the pathology and treatments received.

    Time frame: Up to 60 months

  2. Univariate analysis to identify risk factors related to cognitive disorders.

    Time frame: Up to 60 months

  3. Multiple regression analysis to determine the most significant risk factors and examine the interactions between these factors.

    Time frame: Up to 60 months

Study contacts

Contact information is provided by the study sponsor or research team.

Christelle DUFOUR, MD

CONTACT

[email protected]

+33 (0)1 42 11 42 11

Sponsors and collaborators

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Other

Registry information

Acronym: RISK-N

Important dates

Study start
2014
Primary completion
2025
Study completion
2025
First posted
Aug 1, 2018
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.