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OpenTrials
Completed

NCT Number: NCT03055364

Cognitive Function After Treatment of Primary CNS Malignancy

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.

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Key information

Conditions

CNS Malignancy Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

4 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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

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

    Using the CogState software

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Feb 16, 2017
Registry last updated
May 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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