Assessing neurocognitive risks in children with solid tumors
Neurocognitive Risks in Children With Solid Tumors
This study is trying to see how solid tumors and their treatments affect the thinking and learning abilities of children aged 6 to 16.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Sex | All |
| Sponsor | Gustave Roussy, Cancer Campus, Grand Paris Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Villejuif, Val De Marne) |
| Trial ID | NCT03609112 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the neurocognitive risks associated with solid tumors in children aged 6 to 16 years. It focuses on identifying factors that contribute to neurocognitive sequelae, including treatment types, tumor characteristics, and environmental influences such as socio-economic status. The study will utilize various assessment tools, including the WISC-V and NEPSY-II, to establish a scoring system for evaluating these risks. The goal is to better understand how these factors interplay and affect cognitive outcomes in young cancer patients.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 to 16 years with a diagnosis of solid tumors who have completed their initial treatment.
Not a fit: Patients with other mental retardation-associated pathologies or those who are non-French speaking may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved risk assessment and tailored interventions for neurocognitive issues in children recovering from solid tumors.
How similar studies have performed: While there have been studies on neurocognitive outcomes in pediatric cancer patients, this specific approach to scoring risks based on multiple factors is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Villejuif, Val De Marne
- Gustave Roussy — Villejuif, Val De Marne, France (Recruiting)
Study contacts
- Study coordinator: Christelle DUFOUR, MD
- Email: christelle.dufour@gustaveroussy.fr
- Phone: +33 (0)1 42 11 42 11
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.