Integration of Neurocognitive Biomarkers Into a Neuro-Oncology Clinic

Neurocognitive Disorders Clinical Trial

Official title:

Integration of Neurocognitive Biomarkers Into a Neuro-Oncology Clinic

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05504681
• Other study ID #: 2020-KOT-004
• Status: Recruiting
• Start date: November 30, 2021
• Est. completion date: November 2027

Study information

• Verified date: May 2024
• Source: Baptist Health South Florida
• Contact: Rupesh R Kotecha
• Phone: 17865962000
• Email: rupeshk[@]baptisthealth.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 2027
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neurocognitive Disorders

Intervention

Other:
• Observational study
It takes the patient on average 15 minutes to complete the Brainlab Cognition app.

Locations

Country	Name	City	State
United States	Miami Cancer Institute	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Baptist Health South Florida	Brainlab AG

Country where clinical trial is conducted

United States, 

References & Publications (10)

Armstrong TS, Wefel JS, Wang M, Gilbert MR, Won M, Bottomley A, Mendoza TR, Coens C, Werner-Wasik M, Brachman DG, Choucair AK, Mehta M. Net clinical benefit analysis of radiation therapy oncology group 0525: a phase III trial comparing conventional adjuvant temozolomide with dose-intensive temozolomide in patients with newly diagnosed glioblastoma. J Clin Oncol. 2013 Nov 10;31(32):4076-84. doi: 10.1200/JCO.2013.49.6067. Epub 2013 Oct 7. — View Citation

Brown PD, Pugh S, Laack NN, Wefel JS, Khuntia D, Meyers C, Choucair A, Fox S, Suh JH, Roberge D, Kavadi V, Bentzen SM, Mehta MP, Watkins-Bruner D; Radiation Therapy Oncology Group (RTOG). Memantine for the prevention of cognitive dysfunction in patients receiving whole-brain radiotherapy: a randomized, double-blind, placebo-controlled trial. Neuro Oncol. 2013 Oct;15(10):1429-37. doi: 10.1093/neuonc/not114. Epub 2013 Aug 16. — View Citation

Casey DL, Pitter KL, Kushner BH, Cheung NV, Modak S, LaQuaglia MP, Wolden SL. Radiation Therapy to Sites of Metastatic Disease as Part of Consolidation in High-Risk Neuroblastoma: Can Long-term Control Be Achieved? Int J Radiat Oncol Biol Phys. 2018 Apr 1;100(5):1204-1209. doi: 10.1016/j.ijrobp.2018.01.008. Epub 2018 Jan 9. — View Citation

De Ruysscher D, Niedermann G, Burnet NG, Siva S, Lee AWM, Hegi-Johnson F. Radiotherapy toxicity. Nat Rev Dis Primers. 2019 Feb 21;5(1):13. doi: 10.1038/s41572-019-0064-5. Erratum In: Nat Rev Dis Primers. 2019 Mar 4;5(1):15. — View Citation

Gilbert MR, Dignam JJ, Armstrong TS, Wefel JS, Blumenthal DT, Vogelbaum MA, Colman H, Chakravarti A, Pugh S, Won M, Jeraj R, Brown PD, Jaeckle KA, Schiff D, Stieber VW, Brachman DG, Werner-Wasik M, Tremont-Lukats IW, Sulman EP, Aldape KD, Curran WJ Jr, Mehta MP. A randomized trial of bevacizumab for newly diagnosed glioblastoma. N Engl J Med. 2014 Feb 20;370(8):699-708. doi: 10.1056/NEJMoa1308573. — View Citation

Gondi V, Pugh SL, Tome WA, Caine C, Corn B, Kanner A, Rowley H, Kundapur V, DeNittis A, Greenspoon JN, Konski AA, Bauman GS, Shah S, Shi W, Wendland M, Kachnic L, Mehta MP. Preservation of memory with conformal avoidance of the hippocampal neural stem-cell compartment during whole-brain radiotherapy for brain metastases (RTOG 0933): a phase II multi-institutional trial. J Clin Oncol. 2014 Dec 1;32(34):3810-6. doi: 10.1200/JCO.2014.57.2909. Epub 2014 Oct 27. — View Citation

Horowitz TS, Suls J, Trevino M. A Call for a Neuroscience Approach to Cancer-Related Cognitive Impairment. Trends Neurosci. 2018 Aug;41(8):493-496. doi: 10.1016/j.tins.2018.05.001. Epub 2018 Jun 12. — View Citation

Lange M, Joly F, Vardy J, Ahles T, Dubois M, Tron L, Winocur G, De Ruiter MB, Castel H. Cancer-related cognitive impairment: an update on state of the art, detection, and management strategies in cancer survivors. Ann Oncol. 2019 Dec 1;30(12):1925-1940. doi: 10.1093/annonc/mdz410. — View Citation

Noll KR, Bradshaw ME, Rexer J, Wefel JS. Neuropsychological Practice in the Oncology Setting. Arch Clin Neuropsychol. 2018 May 1;33(3):344-353. doi: 10.1093/arclin/acx131. — View Citation

Wefel JS, Vardy J, Ahles T, Schagen SB. International Cognition and Cancer Task Force recommendations to harmonise studies of cognitive function in patients with cancer. Lancet Oncol. 2011 Jul;12(7):703-8. doi: 10.1016/S1470-2045(10)70294-1. Epub 2011 Feb 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Learning and memory (Neurocognitive Decline)	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
Primary	Change in Attention and Speed of Processing (Neurocognitive Decline)	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
Primary	Change in Verbal Fluency (Neurocognitive Decline)	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
Primary	Change in Fine motor and speed (Neurocognitive Decline)	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
Primary	Change in Executive functions (Neurocognitive Decline).	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