Neurocognitive Risks in Children With Solid Tumors

Recruiting

• Conditions: Solid Tumor in Children

• Registration Number: NCT03609112
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-01
• Study First Submitted: 2018-07-24
• Study First Submitted QC: 2018-07-24
• Study First Posted: 2018-08-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-13
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Gustave Roussy; 🇫🇷 Villejuif, Val De Marne, France