Work

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

Year: 2024

Type: conference-abstract

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.

Source: Neuro-Oncology Advances

DOI: 10.1093/noajnl/vdae090.090

Authors: Matthias Holdhoff, Priya Kumthekar, Honey Reddi, Stephanie Reiners, Chetan Bettegowda

Institutions: Johns Hopkins University, Sidney Kimmel Comprehensive Cancer Center, Northwestern University

Language: English

Topic: Cancer Genomics and Diagnostics

Subfield: Cancer Research

Field: Biochemistry, Genetics and Molecular Biology

Domain: Life Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $2,824