Integration of Neurocognitive Biomarkers Into a Neuro-Oncology Clinic

May 21, 2024 updated by: Baptist Health South Florida
This is prospective observational registry study that will assess 1) if the neurocognitive function app (Brainlab Cognition) can be used in a widespread neuro-oncology clinic setting and 2) if patient reported quality of life parameters can be obtained electronically and integrated into clinic.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All adult (18+) patients with CNS tumors, both primary brain malignancies and brain metastases, treated with radiotherapy (partial brain, stereotactic radiosurgery, stereotactic fractionated radiotherapy, or whole-brain radiotherapy), surgery, and/or antineoplastic therapy and followed thereafter at Miami Cancer Institute (MCI).

Description

Inclusion Criteria:

  1. All adult (18+) patients with central nervous system (CNS) tumors, both primary brain malignancies and brain metastases, treated with radiotherapy (partial brain, stereotactic radiosurgery, stereotactic fractionated radiotherapy, or whole-brain radiotherapy), surgery, and/or antineoplastic therapy and followed thereafter at Miami Cancer Institute (MCI)
  2. Life expectancy ≥ 6 months
  3. Willingness to participate in ongoing registration study

Exclusion Criteria:

  1. Patients receiving radiotherapy to the brain for functional disease (arteriovenous malformations, trigeminal neuralgia, essential tremors, etc.)
  2. Pediatric patients (<18 years old), pregnant women, and prisoners.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Learning and memory (Neurocognitive Decline)
Time Frame: Baseline, 2, 4, 6, 12, 18, 24 months
Learning and memory will be assessed by the number of correct responses (the total number of words correctly recalled). The "Verbal Recall" test will be used to measure the number of correct responses over 3 trials, the "Verbal Revision" will be used to measure the number of total correct responses, and the "Verbal Recognition" test will be used to measure number of correct responses minus the incorrect responses. Change is calculated as baseline score subtracted from post-baseline score over time.
Baseline, 2, 4, 6, 12, 18, 24 months
Change in Attention and Speed of Processing (Neurocognitive Decline)
Time Frame: Baseline, 2, 4, 6, 12, 18, 24 months
This will be measured by the "Symbols Matching" test. Subjects will be asked to match symbols and corresponding numbers during 90 seconds. The score will be calculated by totaling the number of correct answers during the allotted time. A higher score indicates better functioning.
Baseline, 2, 4, 6, 12, 18, 24 months
Change in Verbal Fluency (Neurocognitive Decline)
Time Frame: Baseline, 2, 4, 6, 12, 18, 24 months
This will be measured by the "Words That Start With" test. The total number of words correctly generated (no numbers, no proper names) by the subject will be recorded to generate their score. A higher score indicates better functioning.
Baseline, 2, 4, 6, 12, 18, 24 months
Change in Fine motor and speed (Neurocognitive Decline)
Time Frame: Baseline, 2, 4, 6, 12, 18, 24 months
This will be measured by the "Numbers Ordering" test. This test assesses visual scanning and motor tracking requiring focused attention. Subjects are required to sequentially connect numbered dots in ascending order that are randomly scattered on the screen in consecutive order. The total time in seconds to complete the array will be recorded as the score result. A lower score indicates better functioning.
Baseline, 2, 4, 6, 12, 18, 24 months
Change in Executive functions (Neurocognitive Decline).
Time Frame: Baseline, 2, 4, 6, 12, 18, 24 months
This will be measured by "Numbers and Letters Ordering" test. This test includes a divided attention component requiring mental flexibility (i.e., executive function). On this subtest, dots with numbers and letters are randomly scattered. Subjects are required to alternate between connecting numbers and letters in an ascending sequential order. Subjects will order numbers and letters from 1 to 13 and from A to M by tapping them as fast as possible in consecutive and alternating order. The total time in whole seconds to complete the array will be recorded. A lower score indicates better functioning.
Baseline, 2, 4, 6, 12, 18, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baptist Health South Florida

Collaborators

Brainlab AG

Investigators

  • Principal Investigator: Rupesh R Kotecha, MD, Miami Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2021

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

April 8, 2022

First Submitted That Met QC Criteria

August 15, 2022

First Posted (Actual)

August 17, 2022

Study Record Updates

Last Update Posted (Actual)

May 22, 2024

Last Update Submitted That Met QC Criteria

May 21, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-KOT-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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