Status:
COMPLETED
Sputum Labeling Utilizing Synthetic Meso-Tetra (4-Carboxyphenyl) Porphyrin (TCPP) for Detection of Lung Cancer
Lead Sponsor:
bioAffinity Technologies Inc.
Conditions:
Lung Cancer
Eligibility:
All Genders
21-75 years
Brief Summary
The primary objective of this study is optimization of the assay to discriminate between cancer cells and non-cancer cells in sputum samples by the performance of experiments that will determine metho...
Detailed Description
A clinical study was completed to determine the clinical sensitivity and specificity of the CyPath® Early Lung Cancer Detection Assay (the "Assay") by comparing sputum specimens from three cohorts of ...
Eligibility Criteria
Inclusion
- Each subject must meet the following criteria to be enrolled in this study:
- Male or female
- Study Participants must be willing to provide primary care physician contact information and agree to have medical information released if indicated
- Meet requirements of one of three cohorts in the study:
- Healthy Cohort: Current non-smoker who has smoked less than 5 pack-years in his or her lifetime, and if smoked, has quit for more than 15 years ago and who has no known lung disease.
- High Risk Cohort: Current smoker, or individual who has quit smoking less than 15 years before study start, who has smoked more than 30 pack-years in his or her lifetime.
- Cancer Cohort: Individual who has been diagnosed by a physician with lung cancer.
Exclusion
- Participants who meet any of the following criteria will be excluded from the study:
- Lung disease
- Angina with minimal exertion
- Pregnancy
- Have or have had cancer other than lung cancer
- Worked in the mining Industry
Key Trial Info
Start Date :
September 22 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 15 2018
Estimated Enrollment :
197 Patients enrolled
Trial Details
Trial ID
NCT03837600
Start Date
September 22 2016
End Date
August 15 2018
Last Update
July 27 2023
Active Locations (5)
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1
Waterbury Pulmonary Associates LLC
Waterbury, Connecticut, United States, 06708
2
Meridian Health
Neptune City, New Jersey, United States, 07753
3
Atlantic Respiratory Institute
Summit, New Jersey, United States, 07901
4
Radiology Associates of Albuquerque
Albuquerque, New Mexico, United States, 87109