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Clinical Trials/NCT03055364
NCT03055364
Completed
N/A

Observational Study Evaluating Neurocognitive Function in Patients With Primary CNS Malignancy Receiving Radiation Treatment to the Brain

Mayo Clinic1 site in 1 country129 target enrollmentJune 13, 2017
ConditionsCNS Malignancy

Overview

Phase
N/A
Intervention
Not specified
Conditions
CNS Malignancy
Sponsor
Mayo Clinic
Enrollment
129
Locations
1
Primary Endpoint
characterize the rate and magnitude of change in cognitive performance within 12 months of completion of therapy in patients with intracranial malignancies receiving photon- or proton-based cranial irradiation with curative intent
Status
Completed
Last Updated
last year

Overview

Brief Summary

In this study, the investigators propose to evaluate cognitive function and determine the feasibility of neurocognitive assessment using a select CogState test battery in patients with primary intracranial malignancies receiving photon- or proton-based cranial irradiation with curative intent. The investigators will use the CogState software to quantify changes in verbal learning, memory, and executive function over the initial months and years following radiation treatment. Cognitive changes and temporal patterns of function will be compared to baseline performance for each patient. Data regarding cognitive function, fatigue, quality of life, and standard patient reported outcomes will be collected to characterize the daily impact of treatment. In addition, observed outcomes will be correlated with dosimetry values, radiation dose volumes, and anatomic dose distribution.

Registry
clinicaltrials.gov
Start Date
June 13, 2017
End Date
November 2, 2023
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nadia N. Laack, M.D.

Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

  • Age ≥ 4 years with primary CNS malignancy
  • Able to use computer for assessment battery
  • Receiving photon- or proton-based radiation for primary intracranial malignancy
  • Demonstrates the capacity to sign informed consent

Exclusion Criteria

  • Patients with WHO Grade IV tumors

Outcomes

Primary Outcomes

characterize the rate and magnitude of change in cognitive performance within 12 months of completion of therapy in patients with intracranial malignancies receiving photon- or proton-based cranial irradiation with curative intent

Time Frame: baseline, completion of treatment, 3 months, 6 months, 1 year and 2 years after radiotherapy

Using the CogState software

Study Sites (1)

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