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โ† Trials
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Collection of Sputum and Labeling for Lung Cancer

Recruitingn/aAges 21 Years - anyAllbioAffinity Technologies Inc.
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In plain words

What the trial is, and whether it could suit you

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) acapellaยฎ airway assist device under medical supervision to obtain a s

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ55-74 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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What it tests

  • Not listed
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Where

3 sites
Atlantic Respiratory Institute
Summit, United States
Radiology Associates of Albuquerque
Albuquerque, United States
South Texas Veterans Health Care System (STVHCS)/Audie L. Murphy Memorial Veterans Hospital
San Antonio, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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