Status:
RECRUITING
Collection of Sputum and Labeling for Lung Cancer
Lead Sponsor:
bioAffinity Technologies Inc.
Conditions:
Lung Cancer
Eligibility:
All Genders
21+ years
Brief Summary
The primary objective of this study is to compare Assay results to diagnoses determined by currently accepted standards for lung cancer detection. This will be accomplished by analysis of sputum sampl...
Detailed Description
This study will be performed at multiple study centers to collect sputum samples from three cohorts including (1) healthy Participants, (2) individuals at high risk for lung cancer and (3) individuals...
Eligibility Criteria
Inclusion
- Each subject must meet the following criteria to be enrolled in this study:
- Male or female
- 21 years of age or older
- Willing to provide primary care physician contact information to the investigator 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, quit more than 15 years ago, and has no known lung disease.
- High Risk Cohort: Individual aged ≥55-74 who is a current smoker with a smoking history of at least 30 pack-years, or current non-smoker who has a smoking history of at least 30 pack-years, and quit smoking within the past 15 years.
- Cancer Cohort: Individual who has been diagnosed by a physician as highly suspect for having lung cancer but has not yet undergone a biopsy nor received therapy, and after providing a sputum sample is confirmed to have lung cancer by biopsy.
Exclusion
- Participants who meet any of the following criteria will be excluded from the study:
- Severe obstructive lung disease and unable to cough with sufficient exertion to produce a sputum sample. Participants with lung disease that are able to cough with sufficient exertion to produce a sputum sample are not excluded from the study
- Angina with minimal exertion
- Pregnancy
Key Trial Info
Start Date :
March 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT03457415
Start Date
March 1 2018
End Date
December 1 2025
Last Update
April 1 2025
Active Locations (3)
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1
Atlantic Respiratory Institute
Summit, New Jersey, United States, 07901
2
Radiology Associates of Albuquerque
Albuquerque, New Mexico, United States, 87109
3
South Texas Veterans Health Care System (STVHCS)/Audie L. Murphy Memorial Veterans Hospital
San Antonio, Texas, United States, 78229