Sputum Labeling Utilizing Synthetic Meso Tetra (4-Carboxyphenyl) Porphine (TCPP) for Detection of Lung Cancer
- 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.
- 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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
|Official Title:||Sputum Labeling Utilizing Synthetic Meso Tetra (4-Carboxyphenyl) Porphine (TCPP) for Detection of Lung Cancer|
- 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. [ Time Frame: March 2011 ] [ Designated as safety issue: No ]
|Study Start Date:||March 2009|
|Study Completion Date:||March 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
Single Arm Labeling of Deep-Lung Sputum Samples with TCPP
Deep-lung sputum was obtained from two cohorts, including (1) high-risk control group comprised of individuals not diagnosed but at high risk for lung cancer (n=102) and, (2) cancer group comprised of individuals with confirmed lung cancer diagnosis (n=26), was labeled in exact manner with TCPP and evaluated to detect red fluorescent [ie, cancer] cells (RFCs) from deep-lung sputum samples.
CyPath diagnostic assay for the early detection of lung cancer using sputum
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.
Study results showed that the CyPath® Assay is a significant new biomarker for lung cancer with sensitivity at 77% and specificity at 58%, and an overall accuracy of 81.3% in the ability of the CyPath® assay and specific patient factors to correctly classify groups of Study participants into the cancer or high-risk cohorts. Testing for the Study was performed at multiple locations to assess the efficacy of the CyPath® Assay to detect lung cancer cells exfoliated from lung tumors present in deep-lung sputum. Participants who satisfied the inclusion/exclusion criteria were enrolled in the Study and assigned to one of two cohorts (smoker with clear LDCT scan or "high-risk normals," and lung cancer confirmed by pathology or "cancer").
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.
|United States, Connecticut|
|Waterbury Pulmonary Research|
|Waterbury, Connecticut, United States, 06708|
|United States, Delaware|
|Helen F. Graham Cancer Center, Christiana Care Health System|
|Newark, Delaware, United States, 19713|
|United States, New Mexico|
|Radiology Associates of Albuquerque|
|Albuquerque, New Mexico, United States, 87109|
|Study Director:||Constance Dorian, BS Biology|
|Principal Investigator:||Lara Patriquin, MD||Radiology Associates of Albuquerquqe|
|Principal Investigator:||Thomas Bauer, MD||Helen F Graham Cancer Center, Christiana Care|