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Recruiting NCT05504681

Integration of Neurocognitive Biomarkers Into a Neuro-Oncology Clinic

— Observational Neurocognitive Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Observational study.
Who it may be relevant to
Registry conditions: Neurocognitive Disorders. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Change in Learning and memory (Neurocognitive Decline) [Time frame: 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]
  • Change in Verbal Fluency (Neurocognitive Decline) [Time frame: 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]
  • Change in Executive functions (Neurocognitive Decline). [Time frame: Baseline, 2, 4, 6, 12, 18, 24 months]

Eligibility criteria

Inclusion criteria

  • 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)
  • Life expectancy ≥ 6 months
  • Willingness to participate in ongoing registration study

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Miami Cancer Institute — Miami

Publications

  • 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. PMID 21354373
  • 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. PMID 29718081
  • 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. PMID 29907436
  • 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 PMID 24101048
  • 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. PMID 24552317
  • 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. PMID 31617564
  • 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/neuon PMID 23956241
  • 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 PMID 25349290

Identifiers

NCT: NCT05504681 · 2020-KOT-004

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗