Lung Cancer
Conditions
Keywords
Lung Cancer, Porphyrin, Fluorescence, Diagnostic, Sputum Cytology, Early Detection
Brief summary
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.
Detailed description
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.
Interventions
DEVICECyPath®
CyPath® diagnostic assay for the early detection of lung cancer using sputum
Sponsors
Radiology Associates of Albuquerque
bioAffinity Technologies Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participants who have never smoked nor have known lung diseases
Exclusion criteria
* Severe obstructive lung disease * Angina with minimal exertion * Pregnancy * Have or have had cancer other than lung cancer * Worked in the mining Industry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Red Fluorescent [i.e., Cancer] Cells (RFCs) in Sputum From Healthy Participants | 2 months | The presence or absence of red fluorescent (RFCs) cancer cells was evaluated in sputum samples from healthy individuals labeled with CyPath®. Testing for the study was performed at one study center to collect sputum samples from healthy individuals who have no known lung disease. Comparison of sputum specimens from one cohort of Participants who are healthy with two additional cohorts of Participants, including individuals at high risk for lung cancer and individuals diagnosed with lung cancer, that has already been completed. |
Countries
United States
Participant flow
Recruitment details
The study was performed at Radiology Associates of Albuquerque (RAA), New Mexico during the recruitment period of March 2015 to April 20, 2015
Participants by arm
| Arm | Count |
|---|---|
| CyPath® Assay of Deep-Lung Sputum Sample Deep-lung sputum was obtained from healthy individuals who had no known lung disease, was labeled with TCPP and evaluated to detect red fluorescent \[ie, cancer\] cells (RFCs) from deep-lung sputum samples.
CyPath®: CyPath® diagnostic assay for the early detection of lung cancer using sputum | 22 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost in Transit | 2 |
| Overall Study | Sample Not Returned | 1 |
Baseline characteristics
| Characteristic | CyPath® Assay of Deep-Lung Sputum Sample |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
Number of Red Fluorescent [i.e., Cancer] Cells (RFCs) in Sputum From Healthy Participants
The presence or absence of red fluorescent (RFCs) cancer cells was evaluated in sputum samples from healthy individuals labeled with CyPath®. Testing for the study was performed at one study center to collect sputum samples from healthy individuals who have no known lung disease. Comparison of sputum specimens from one cohort of Participants who are healthy with two additional cohorts of Participants, including individuals at high risk for lung cancer and individuals diagnosed with lung cancer, that has already been completed.
Time frame: 2 months
Population: 22 participants were evaluated by a cytopathologist. Of these 22, PAP-stained slides of 3 participants were unreadable, 14 participants had provided samples that were confirmed by PAP as inadequate and only 5 slides were confirmed by PAP as adequate deep lung sputum samples. These 5 samples were evaluated for the presence of RFCs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CyPath® Assay of Deep-Lung Sputum Sample | Number of Red Fluorescent [i.e., Cancer] Cells (RFCs) in Sputum From Healthy Participants | 0 number of RFCs per participant | Standard Deviation 0 |