Clinical trial NCT05504681: Integration of Neurocognitive Biomarkers Into a Neuro-Oncology Clinic
Official title: Integration of Neurocognitive Biomarkers Into a Neuro-Oncology Clinic
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neurocognitive Disorders
Keywords: Neurocognitive
Brainlab Cognition app
Lead sponsor: Baptist Health South Florida
Sponsor class: OTHER
Collaborators: name: Brainlab AG
First posted: 2022-08-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Change in Learning and memory (Neurocognitive Decline)
timeFrame: Baseline, 2, 4, 6, 12, 18, 24 months
measure: Change in Attention and Speed of Processing (Neurocognitive Decline)
timeFrame: Baseline, 2, 4, 6, 12, 18, 24 months
measure: Change in Verbal Fluency (Neurocognitive Decline)
timeFrame: Baseline, 2, 4, 6, 12, 18, 24 months
measure: Change in Fine motor and speed (Neurocognitive Decline)
timeFrame: Baseline, 2, 4, 6, 12, 18, 24 months
measure: Change in Executive functions (Neurocognitive Decline).
timeFrame: Baseline, 2, 4, 6, 12, 18, 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami Cancer Institute
state: Florida
Study officials:
affiliation: Miami Cancer Institute
name: Rupesh R Kotecha, MD
role: PRINCIPAL_INVESTIGATOR
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