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Cognitive Function After Treatment of Primary CNS Malignancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03055364
Recruitment Status : Recruiting
First Posted : February 16, 2017
Last Update Posted : June 11, 2020
Information provided by (Responsible Party):
Nadia N. Laack, M.D., Mayo Clinic

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
CNS Malignancy

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Study Type : Observational
Estimated Enrollment : 160 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
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

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 [ Time Frame: baseline, completion of treatment, 3 months, 6 months, 1 year and 2 years after radiotherapy ]
    Using the CogState software

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with primary CNS malignancy

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03055364

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Contact: Clinical Trials Referral Office 855-776-0015

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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Referral Office    855-776-0015      
Sponsors and Collaborators
Mayo Clinic
Additional Information:
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Responsible Party: Nadia N. Laack, M.D., MD, Mayo Clinic Identifier: NCT03055364    
Other Study ID Numbers: 16-005982
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases