Collecting and analyzing sputum samples for lung cancer detection
Collection of Sputum and Sputum Labeling Utilizing Synthetic Meso-Tetra (4-Carboxyphenyl) Porphyrin (TCPP) for Detection of Lung Cancer
This study is testing if analyzing sputum samples can help detect lung cancer better than current methods in healthy people, those at high risk, and patients already diagnosed with lung cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | bioAffinity Technologies Inc. Industry-sponsored |
| Locations | 3 sites (Summit, New Jersey and 2 other locations) |
| Trial ID | NCT03457415 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 21 and older who fit into one of the three cohorts: healthy, high-risk smokers, or diagnosed lung cancer patients.
Not a fit: Patients who are not within the specified age range or do not meet the cohort criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance early detection of lung cancer, potentially leading to better patient outcomes.
How similar studies have performed: Other studies have shown promise in using sputum analysis for lung cancer detection, suggesting this approach may be viable.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Summit, New Jersey and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.