Lung Cancer Clinical Trial
Official title:
Sputum Labeling Utilizing Synthetic Meso Tetra (4-Carboxyphenyl) Porphine (TCPP) for Detection of Lung Cancer
Primary Objective:
- To determine the clinical sensitivity and specificity of the Biomoda CyPath™ Early Lung
Cancer Detection Assay using sputum specimens from two cohorts of participants and
estimate the required sample size to finalize a protocol for a pivotal study.
Secondary Objectives:
- To assess the capability of the Biomoda CyPath™ Early Lung Cancer Detection Assay in a
clinical setting to identify cancer cells, as assessed by TCPP labeled cancer cells
demonstrating red fluorescence under a microscope with ultraviolet (UV) light being
observed with a FITC (Fluorescein isothiocyanate) Filter.
- To assess the capability of the Biomoda CyPath™ Early Lung Cancer Detection Assay to
detect pre-invasive cancer in comparison with PAP sputum cytology and routine CT scan.
Meso Tetra (4-Carboxyphenyl) Porphine (TCPP) is a porphyrin that can label cancer cells by
reacting to the increased number of low-density lipoproteins coating the surface of cancer
cells and the porous nature of the cancer cell membrane, causing the cell to fluoresce under
specific wavelengths of light. The primary objective of this clinical trial was to determine
the clinical sensitivity and specificity of the CyPath® Lung Cancer Detection Assay ("CyPath®
Assay") using sputum specimens from two cohorts of Participants. The Study design included a
protocol to assess the capability of the Biomoda CyPath® Lung Cancer Detection Assay to
detect cancer in comparison with routine high-resolution, low-dose Computed Tomography (LDCT)
scans.
Optimization of the Assay can lead to improved sensitivity and specificity. Increase in
sample size and evaluation of the entire sputum sample can increase data collection and
differentiation between cohorts. Technicians in the current Study examined 12 slides
containing approximately 600,000 cells. The average sputum sample pellet translates to a
potential of approximately 3.5 million cells for evaluation. Evaluating the full sputum
sample with the CyPath® Assay can be accomplished through flow cytometry and would increase
the capture and analysis of exfoliated cancer cells in the sample. In-house studies evaluated
samples from five different cancer cell lines using flow cytometry. Preliminary results
showed that cancer cell lines were detected with significant fluorescence apart from normal
cell fluorescence. Refinements for using the flow cytometer include optimizing the
liquid-based assay and sample analysis and focus on concentration, incubation time and
optimal sample volume.
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