This is a single center study to assess the efficacy of CyPath® Early Detection Lung Cancer
Assay to detect lung cancer cells from deep lung 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 is to determine
the the presence or absence of red fluorescent [ie, cancer] cells (RFCs) from deep-lung
sputum samples using the CyPath® Early Lung Cancer Detection Assay from one cohort of
Participants who are healthy. The results from this trial will be compared with two
additional cohorts of Participants including individuals at high risk for lung cancer and
individuals diagnosed with lung cancer. Collection of the sputum samples from high-risk
individuals and lung cancer patients is complete (NCT00894127).
Participants who satisfy the inclusion/exclusion criteria will be enrolled into the study
and assigned to the healthy cohort. The sputum samples will be collected at the study site
or at the Participant's home after explanation of the collection procedure by study staff.
Samples will be identified with an identification number blinding the sample identity.
Each subject's sputum specimen will be processed onto 13 microscope slides at the University
of Texas Health Science Center of San Antonio (UTHSCSA) Laboratory. The UTHSCSA laboratory
will process each sputum sample onto slides using the ThinPrep T2000 processor for use in
the CyPath® Early Lung Cancer Detection Assay.
Twelve slides from each sputum sample will be labeled with CyPath®. One slide will be used
to preform PAP staining for the presence of macrophages. Macrophages are an indication that
the sputum sample is from deep within the lungs. A cytopathologist will review the slide and
record results on a specimen adequacy form. bioAffinity researchers who will be blinded as
to the Participant's identity will perform the CyPath® labeling and scoring of the slides.
The study results of the healthy cohort will be used for comparison with the results of a
closed study in which the sputum from individuals at high risk of lung cancer and
individuals diagnosed with lung cancer was compared.
Findings of the CyPath® assay will not be used in the diagnosis or treatment of
- Participants who have never smoked nor have known lung diseases
- Severe obstructive lung disease
- Angina with minimal exertion
- Have or have had cancer other than lung cancer
- Worked in the mining Industry