Clinical trial NCT02388074: Sputum Labeling Utilizing Synthetic Meso-Tetra (4-Carboxyphenyl) Porphine (TCPP) for Detection of Lung Cancer
Official title: Sputum Labeling Utilizing Synthetic Meso Tetra (4-Carboxyphenyl) Porphine (TCPP) for Detection of Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: Lung Cancer
Porphyrin
Fluorescence
Diagnostic
Sputum Cytology
Early Detection
Lead sponsor: bioAffinity Technologies Inc.
Sponsor class: INDUSTRY
Collaborators: name: Radiology Associates of Albuquerque
First posted: 2015-03-13
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Red Fluorescent [i.e., Cancer] Cells (RFCs) in Sputum From Healthy Participants
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: Radiology Associates of Albuquerque (RAA)
state: New Mexico
Study officials:
affiliation: Radiology Associates of Albuquerque
name: Lara Patriquin, MD
role: PRINCIPAL_INVESTIGATOR
References: