No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
21 and older
Sex
Any
Study type
Observational
Participants needed
500 (estimated)
Sponsor
bioAffinity Technologies Inc. · Industry
Who this trial is looking for
This trial is looking for people with lung cancer, those at high risk for it, and healthy individuals. Participants will provide sputum samples using different collection methods to help improve lung cancer detection tests.
Are You a Good Fit for This Trial?
You may be able to join if
I am 21 years of age or older
I am willing to provide my primary care physician's contact information
I am a current non-smoker who has smoked less than 5 pack-years in my lifetime
I am a current smoker with a smoking history of at least 30 pack-years
I am a non-smoker with a smoking history of at least 30 pack-years and quit smoking within the last 15 years
I have been diagnosed by a physician as highly suspect for having lung cancer but have not undergone a biopsy nor received therapy
You may not be able to join if
I have severe obstructive lung disease and cannot cough to produce a sputum sample
I have angina with minimal exertion
I am pregnant
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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.
Trial Locations
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Eligibility Criteria
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 require…
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
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