Clinical trial · Observational
Integration of Neurocognitive Biomarkers Into a Neuro-Oncology Clinic
NCT05504681CI-TRIAL-00112028recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neurocognitive Disorders | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Observational study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (5)
- measure
- Change in Learning and memory (Neurocognitive Decline)
- timeFrame
- Baseline, 2, 4, 6, 12, 18, 24 months
- description
- 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.
- measure
- Change in Attention and Speed of Processing (Neurocognitive Decline)
- timeFrame
- Baseline, 2, 4, 6, 12, 18, 24 months
- description
- 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.
- measure
- Change in Verbal Fluency (Neurocognitive Decline)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (10)
- BACKGROUNDWefel 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
- BACKGROUNDNoll 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
- BACKGROUNDHorowitz 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
- BACKGROUNDArmstrong 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. PMID 24101048
- BACKGROUNDGilbert 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
- BACKGROUNDLange 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