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Cognitive Function After Treatment of Primary CNS Malignancy

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Nadia N. Laack, M.D., Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Nadia N. Laack, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT03055364
First received: February 13, 2017
Last updated: May 24, 2017
Last verified: May 2017
  Purpose
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
CNS Malignancy

Study Type: Observational
Study Design: 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

Further study details as provided by Nadia N. Laack, M.D., Mayo Clinic:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 160
Actual Study Start Date: May 24, 2017
Estimated Study Completion Date: May 2021
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   4 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with primary CNS malignancy
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03055364

Contacts
Contact: Clinical Trials Referral Office 855-776-0015 tranby.brianna@mayo.edu

Locations
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
  More Information

Responsible Party: Nadia N. Laack, M.D., MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03055364     History of Changes
Other Study ID Numbers: 16-005982
Study First Received: February 13, 2017
Last Updated: May 24, 2017

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
Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases

ClinicalTrials.gov processed this record on July 21, 2017