Columbia University Medical Center Sponsors Clinical Study Using Biocept's Liquid Biopsy Platform to Evaluate Cerebrospinal Fluid of Breast Cancer Patients for Metastatic Biomarkers
"Diagnosing LM in patients with breast cancer can be challenging given the low diagnostic sensitivity of traditional methods such as cytologic analysis," stated
The clinical trial is expected to enroll 46 patients with breast cancer who are undergoing lumbar puncture to detect the presence of LM. The primary study objective is to determine whether
- Comparing each patient's CTCs and cfDNA collected in CSF with blood samples.
- Comparing the performance of
Biocept's Target Selector™ CTC platform to standard cytopathology in diagnosing LM within 2 subgroups: patients with LM confirmed by MRI and those with suspicious LM findings from MRI. - Exploring CTC and cfDNA levels from the CSF of patients with an initial negative LM finding using standard cytopathologic and CTC analysis.
- Assessing the feasibility of determining estrogen, progesterone and HER2 receptor status on CTCs collected from CSF samples using
Biocept's Target Selector™ technology. - Assessing concordance between the receptor status of the primary and/or metastatic tumor and that of the LM cells collected using
Biocept's Target Selector™ technology.
"We are very pleased to again collaborate with
About Leptomeningeal Disease in Breast Cancer
Leptomeningeal metastasis (LM) is a condition in which cancer cells seed the meninges (nerve tissue in the spine and brain) and may go on to invade the brain, spinal cord, cranial nerves or peripheral nerves. It is a devastating complication of breast cancer, and is often considered in the differential diagnosis when patients with breast cancer present with new neurological symptoms. It was previously thought to be a rare occurrence, but autopsy series have shown the true overall incidence to be up to 8%. In fact, while the incidence of meningeal metastasis in other cancers has decreased, the opposite is true of breast cancer, in which the clinical evidence suggests an increasing incidence. Diagnosing LM can be difficult. The diagnosis is traditionally based on CSF cytologic analysis, but more recently, MRIs of the brain and spine are being used as first-line diagnostics because of their noninvasive nature. However, MRI findings can be ambiguous, and confirmatory findings may be difficult with cytopathologic analysis. CSF cytopathologic analysis is used to provide diagnostic confirmation of LM, but is associated with relatively low sensitivity (~50% on the first lumbar puncture) and is highly examiner dependent. Repeat multi-site and high volume lumbar punctures are often required, which may increase sensitivity up to 90%, but are associated with patient discomfort, treatment delays, and complications.
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This release contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although we believe that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, we can give no assurance that such expectations and assumptions will prove to have been correct. Forward-looking statements are generally identifiable by the use of words like "may," "will," "should," "could," "expect," "anticipate," "estimate," "believe," "intend," or "project" or the negative of these words or other variations on these words or comparable terminology. To the extent that statements in this release are not strictly historical, including without limitation statements as to our ability to improve the outcome of cancer patients, the clinical utility of our liquid biopsy
technology to improve the diagnosis and treatment of LM, and the future market opportunities and commercial expansion of our liquid biopsy technology, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous risk factors as set forth in our
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