Integration of Neurocognitive Biomarkers Into a Neuro-Oncology Clinic
NCT ID: NCT05504681
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2021-11-30
2027-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Observational study
It takes the patient on average 15 minutes to complete the Brainlab Cognition app.
Eligibility Criteria
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Inclusion Criteria
2. Life expectancy ≥ 6 months
3. Willingness to participate in ongoing registration study
Exclusion Criteria
2. Pediatric patients (\<18 years old), pregnant women, and prisoners.
18 Years
ALL
No
Sponsors
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Brainlab AG
INDUSTRY
Baptist Health South Florida
OTHER
Responsible Party
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Principal Investigators
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Rupesh R Kotecha, MD
Role: PRINCIPAL_INVESTIGATOR
Miami Cancer Institute
Locations
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Miami Cancer Institute
Miami, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Rupesh Kotecha
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2020-KOT-004
Identifier Type: -
Identifier Source: org_study_id