Trial Outcomes & Findings for Sputum Labeling Utilizing Synthetic Meso-Tetra (4-Carboxyphenyl) Porphine (TCPP) for Detection of Lung Cancer (NCT NCT02388074)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

2 months

Results posted on

2015-07-14

Participant Flow

The study was performed at Radiology Associates of Albuquerque (RAA), New Mexico during the recruitment period of March 2015 to April 20, 2015

Participant milestones

Participant milestones
Measure	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 \[i.e., cancer\] cells (RFCs) from deep-lung sputum samples. CyPath®: CyPath® diagnostic assay for the early detection of lung cancer using sputum
Overall Study STARTED	25
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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 \[i.e., cancer\] cells (RFCs) from deep-lung sputum samples. CyPath®: CyPath® diagnostic assay for the early detection of lung cancer using sputum
Overall Study Lost in Transit	2
Overall Study Sample Not Returned	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CyPath® Assay of Deep-Lung Sputum Sample n=22 Participants 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
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Sex: Female, Male Female	17 Participants n=99 Participants
Sex: Female, Male Male	5 Participants n=99 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	CyPath® Assay of Deep-Lung Sputum Sample n=5 Participants 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
Number of Red Fluorescent [i.e., Cancer] Cells (RFCs) in Sputum From Healthy Participants	0 number of RFCs per participant Standard Deviation 0

Adverse Events

CyPath® Assay of Deep-Lung Sputum Sample

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Bijal Karia, PhD Director of Research

bioAffinity Technologies Inc.

Phone: 2107485287

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place