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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lung Cancer

Intervention / Treatment
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* Device: CyPath®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CyPath® Assay of Deep-Lung Sputum Sample<br>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. | Device: CyPath®<br>* CyPath® diagnostic assay for the early detection of lung cancer using sputum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Cancer, Porphyrin, Fluorescence, Diagnostic, Sputum Cytology, Early Detection