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Sputum Labeling Utilizing Synthetic Meso Tetra (4-Carboxyphenyl) Porphine (TCPP) for Detection of Lung Cancer

Phase 1/Phase 2
18 Years
Not Enrolling
Lung Cancer

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Trial Information

Sputum Labeling Utilizing Synthetic Meso Tetra (4-Carboxyphenyl) Porphine (TCPP) for Detection of Lung Cancer

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.

Inclusion Criteria:

- Male or female Veterans

- Study Participants must be willing to provide primary care physician contact
information and agree to have medical information released if indicated

- Meet requirements of one of the two cohorts in the study:

- Cohort 1: Heavy Smoker

- Defined as 20 pack years or greater (e.g., 1 pack/day for 20 years or 2
packs/day for 10 years).

- Cohort 2: Known Lung Cancer

- Recently diagnosed with Stage I - IV lung cancer with either central
(bronchogenic) or peripheral tumor location, and prior to surgery or other
therapy for the cancer; Participants with a central or peripheral pulmonary
recurrence of lung cancer following primary therapy may also be enrolled.
Sputum samples for this cohort may be collected at or after a diagnostic

Exclusion Criteria:

- Severe obstructive lung disease

- Angina with minimal exertion

- Pregnancy

- Have or have had cancer other than lung cancer within one year

- Worked in the mining Industry

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Outcome Measure:

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.

Outcome Time Frame:

March 2011

Safety Issue:


Principal Investigator

Constance Dorian, BS Biology

Investigator Role:

Study Director


United States: Institutional Review Board

Study ID:




Start Date:

March 2009

Completion Date:

March 2011

Related Keywords:

  • Lung Cancer
  • Lung Cancer
  • Porphyrin
  • Fluorescence
  • Diagnostic
  • Sputum Cytology
  • Early Detection
  • Lung Neoplasms



Waterbury Pulmonary ResearchWaterbury, Connecticut  06708
Helen F. Graham Cancer Center, Christiana Care Health SystemNewark, Delaware  19713
Radiology Associates of AlbuquerqueAlbuquerque, New Mexico  87109