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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02388074
• Other study ID #: MODA-002
• Status: Completed
• Phase: N/A
• First received: March 4, 2015
• Last updated: June 16, 2015
• Start date: March 2015
• Est. completion date: April 2015

Study information

• Verified date: June 2015
• Source: bioAffinity Technologies Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Device:
• CyPath®
CyPath® diagnostic assay for the early detection of lung cancer using sputum

Locations

Country	Name	City	State
United States	Radiology Associates of Albuquerque (RAA)	Albuquerque	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
bioAffinity Technologies Inc.	Radiology Associates of Albuquerque

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	2 months	No