Purpose

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 samples from three cohorts including healthy Participants, high risk Participants, and cancer patient Participants using the Assay as developed in accordance with findings of bioAffinity protocol BA-001 to confirm assay results. Adjustments will be made as necessary to finalize Assay design for clinical trials and commercialization.

The secondary objective of this study is to determine optimum methods for collection of sputum samples. Three sputum collection methods used by high risk Participants will be compared. Individuals at high risk for lung cancer will be assigned to one of three sputum collection cohorts including (1) acapella® airway assist device under medical supervision to obtain a single sputum sample; (2) acapella® airway assist device to obtain a sputum sample over a three-day period, and (3) individuals who under medical supervision will collect a single sputum sample assisted by nebulization of between 0.9% to 10% hypertonic saline. Samples will be compared to determine the optimal collection method for sample analysis by CyPath® Lung.

Category

IRB Number
20180426HU
NCT Number
NCT03457415
Open to Enrollment
Yes
Sponsor
bioAffinity Technologies Inc. -



Study Contact

Principal Investigator
Sheila Habib

Jennifer Whitehead
(210) 986-1295
jennifer.whitehead@va.gov



Eligibility

Eligible Ages
Over 21 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

    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 Criteria

    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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Other
Condition
  • Lung Cancer

    • Arm Groups

    ArmDescriptionIntervention

    Healthy Cohort

    		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.

    Cancer Cohort

    		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.

    High-risk Cohort

    		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.