Cognitive Function After Treatment of Primary CNS Malignancy

NCT ID: NCT03055364

Last Updated: 2024-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

129 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-13

Study Completion Date

2023-11-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

CNS Malignancy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nadia N. Laack, M.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nadia N. Laack, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCI-2024-00947

Identifier Type: REGISTRY

Identifier Source: secondary_id

16-005982

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.