NCT03457415Recruiting
Collection of Sputum and Labeling for Lung Cancer
Collection of Sputum and Sputum Labeling Utilizing Synthetic Meso-Tetra (4-Carboxyphenyl) Porphyrin (TCPP) for Detection of Lung Cancer
Source: ClinicalTrials.gov · Last updated 1 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 1 Mar 2018
- Start date
- 1 Mar 2018
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- bioAffinity Technologies Inc.
- Diseases
- Lung cancer
- NCT number
- NCT03457415
What you commit to
- Study type: Observational
- Planned participants: 500
- From 1 Mar 2018 to the primary completion date, 31 Dec 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Participants who meet any of the following criteria will be excluded from the study:
- Pregnancy
Who the study is looking for
- 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.
Age in the registry: 21 years to - · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Radiology Associates of Albuquerque Coordinator of this site? Confirm its status | Albuquerque | United States | Recruiting |
| South Texas Veterans Health Care System (STVHCS)/Audie L. Murphy Memorial Veterans Hospital Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Atlantic Respiratory Institute Coordinator of this site? Confirm its status | Summit | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.