
==== Front
Neurooncol Adv
Neurooncol Adv
noa
Neuro-Oncology Advances
2632-2498
Oxford University Press US

10.1093/noajnl/vdae090.090
vdae090.090
Final Category: Ongoing Clinical Trials
AcademicSubjects/MED00300
AcademicSubjects/MED00310
OCTS-05 BRAIN BIOMARKER ANALYSIS OF LIKELY TUMOR ORIGIN (BALTO)- A PROSPECTIVE STUDY FOR THE DETECTION/DIAGNOSIS OF CNS TUMORS FROM CSF USING THE BELAY SUMMIT™ ASSAY
Holdhoff Matthias Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA
Johns Hopkins University School of Medicine, Baltimore, MD, USA

Kumthekar Priya The Feinberg School of Medicine at Northwestern University, Chicago, IL, USA

Reddi Honey Belay Diagnostics, Chicago, IL, USA

Reiners Stephanie Belay Diagnostics, Chicago, IL, USA

Bettegowda Chetan Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA
Johns Hopkins University School of Medicine, Baltimore, MD, USA

8 2024
02 8 2024
02 8 2024
6 Suppl 1 2024 SNO/ASCO CNS Metastases Conference i27i27
© The Author(s) 2024. Published by Oxford University Press, the Society for Neuro-Oncology and the European Association of Neuro-Oncology.
2024
https://creativecommons.org/licenses/by-nc/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com

Abstract

Currently, there is a lack of adequate sensitive and specific non- or minimally invasive molecular biomarker technologies to aid in the diagnosis of Central Nervous System (CNS) cancers in patients suspected of having disease based on clinical or radiological findings. Cerebrospinal fluid (CSF) cytology has low sensitivity, necessitating tissue sampling through invasive neurosurgical procedures in most cases. Tumor-derived DNA (ctDNA) has shown potential to detect brain and spinal cord neoplasms by evaluating CSF, offering promise in monitoring dynamic changes in disease burden and evolving mechanisms of resistance in patients undergoing treatment. In this study, we aim to bridge the gap in cytology by utilizing the Belay Summit™ assay, a next generation DNA sequencing-based platform, to identify and characterize tumor derived DNA in CSF across a diverse population in comparison to the current standard of care of histopathology and CSF cytology. Our objective is to demonstrate the performance of the Belay Summit™ assay to help clinicians diagnose and manage patients with suspected or known brain cancer by characterizing the ctDNA present in CSF based on methylation, mutation, and chromosomal copy number. The primary endpoint of this study is to assess the sensitivity and specificity of this novel assay as compared to the current standard of care. This is a multi-center study in patients with known or suspected CNS tumors, with a planned enrollment of 400 individuals. CSF will be collected as part of the standard clinical care in which 2-10 ml will be sent to Belay Diagnostics for testing using the Summit™ assay. Results will be returned to the investigator, and de-identified data will be evaluated to determine the sensitivity and specificity of the assay in the detection/diagnosis of CNS tumors from CSF.
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pmc
