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Neurocognitive Risks in Children With Solid Tumors

Neurocognitive Risks in Children With Solid Tumors

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03609112
Acronym
RISK-N
Enrollment
1000
Registered
2018-08-01
Start date
2014-10-01
Completion date
2025-09-30
Last updated
2024-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumor in Children

Brief 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)

Interventions

OTHERThe 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).

OTHERThe NEPSY-II

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

OTHERThe 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).

OTHERThe 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.

OTHERThe 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.

OTHERThe 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).

OTHERThe '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.

OTHERThe 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.

OTHERThe '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.

Sponsors

Gustave Roussy, Cancer Campus, Grand Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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

Countries

France

Contacts

Primary ContactChristelle DUFOUR, MD
christelle.dufour@gustaveroussy.fr+33 (0)1 42 11 42 11

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026