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Cognitive Function After Treatment of Primary CNS Malignancy

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT03055364
Collaborator
(none)
215
Enrollment
1
Location
79.3
Anticipated Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    215 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Observational Study Evaluating Neurocognitive Function in Patients With Primary CNS Malignancy Receiving Radiation Treatment to the Brain
    Actual Study Start Date :
    May 24, 2017
    Anticipated Primary Completion Date :
    Jan 1, 2024
    Anticipated Study Completion Date :
    Jan 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. 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 [baseline, completion of treatment, 3 months, 6 months, 1 year and 2 years after radiotherapy]

      Using the CogState software

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Nadia Laack, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Nadia N. Laack, M.D., Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT03055364
    Other Study ID Numbers:
    • 16-005982
    First Posted:
    Feb 16, 2017
    Last Update Posted:
    Jun 27, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neoplasms
    Central Nervous System Neoplasms

    Study Results

    No Results Posted as of Jun 27, 2022