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Trial Title:
Integration of Neurocognitive Biomarkers Into a Neuro-Oncology Clinic
NCT ID:
NCT05504681
Condition:
Neurocognitive Disorders
Conditions: Official terms:
Neurocognitive Disorders
Conditions: Keywords:
Neurocognitive
Brainlab Cognition app
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Observational study
Description:
It takes the patient on average 15 minutes to complete the Brainlab Cognition app.
Summary:
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.
Criteria for eligibility:
Study pop:
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).
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Miami Cancer Institute
Address:
City:
Miami
Zip:
33176
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rupesh Kotecha
Phone:
786-596-2000
Email:
rupeshk@baptisthealth.net
Start date:
November 30, 2021
Completion date:
November 2027
Lead sponsor:
Agency:
Baptist Health South Florida
Agency class:
Other
Collaborator:
Agency:
Brainlab AG
Agency class:
Industry
Source:
Baptist Health South Florida
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05504681
