Collecting and analyzing sputum samples for lung cancer detection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to compare assay results from sputum samples to current lung cancer detection standards. It involves three cohorts: healthy participants, high-risk individuals, and diagnosed lung cancer patients. Participants in the high-risk group will undergo low-dose computed tomography (LDCT) scans to confirm their lung health before providing sputum samples. The samples will be processed to identify cell populations and detect cancerous cells using a specialized fluorescent compound.

Why it matters

Who can join: the full rules

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

Where it's running

• Atlantic Respiratory Institute
  Summit, New Jersey, United States Recruiting
• Radiology Associates of Albuquerque
  Albuquerque, New Mexico, United States Recruiting
• South Texas Veterans Health Care System (STVHCS)/Audie L. Murphy Memorial Veterans Hospital
  San Antonio, Texas, United States Recruiting

Study contacts

• Study coordinator: Maria Zannes, JD
• Email: mz@bioaffinitytech.com
• Phone: 505-400-9747

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.