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Clinical Trials/NCT03609112
NCT03609112
Recruiting
Not Applicable

Neurocognitive Risks in Children With Solid Tumors

Gustave Roussy, Cancer Campus, Grand Paris1 site in 1 country1,000 target enrollmentOctober 1, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Solid Tumor in Children
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Enrollment
1000
Locations
1
Primary Endpoint
Descriptive analysis of possible neurocognitive deficits according to the pathology and treatments received.
Status
Recruiting
Last Updated
last year

Overview

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)

Registry
clinicaltrials.gov
Start Date
October 1, 2014
End Date
September 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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

Time Frame: Up to 60 months

Univariate analysis to identify risk factors related to cognitive disorders.

Time Frame: Up to 60 months

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

Time Frame: Up to 60 months

Study Sites (1)

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