Cognitive Function After Treatment of Primary CNS Malignancy

NCT03055364 | Completed

• 2 other identifiers: 16-005982NCI-2024-00947
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

CNS Malignancy

Outcome Measures

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

  Using the CogState software

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

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with primary CNS malignancy

You may qualify if:

• 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

You may not qualify if:

• Patients with WHO Grade IV tumors

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Central Nervous System Neoplasms

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases

Study Officials

• Nadia N. Laack, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 13, 2017
• First Posted: February 16, 2017
• Study Start: June 13, 2017
• Primary Completion: November 2, 2023
• Study Completion: November 2, 2023
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)