Sputum Labeling Utilizing Synthetic Meso-Tetra (4-Carboxyphenyl) Porphyrin (TCPP) for Detection of Lung Cancer
The primary objective of this study is optimization of the assay to discriminate between cancer cells and non-cancer cells in sputum samples by the performance of experiments that will determine methods to liquefy sputum, select proper fixatives and buffers, determine the efficacy of use of methyl-beta-cyclodextrin (MBCD) in sputum processing and determine the use of flow cytometry for high-throughput, and in the establishment of cell count and sputum cell populations in patient samples. The secondary objective of this study is comparison of the characteristics of sputum from three cohorts labeled with CyPath Lung to determine differential characteristics between samples taken from Participants who are not at high risk for lung cancer, Participants at high risk for lung cancer who are free of the disease and Participants with confirmed lung cancer.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jul 27, 2023 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Observational
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Not specified
- Study type
- Observational
- Phase
- Not applicable
- Sponsor
- bioAffinity Technologies Inc.
- Interventions being studied
- Not specified
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Each subject must meet the following criteria to be enrolled in this study:
- Male or female
- Study Participants must be willing to provide primary care physician contact information 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, has quit for more than 15 years ago and who has no known lung disease.
- High Risk Cohort: Current smoker, or individual who has quit smoking less than 15 years before study start, who has smoked more than 30 pack-years in his or her lifetime.
- Cancer Cohort: Individual who has been diagnosed by a physician with lung cancer.
- Participants who meet any of the following criteria will be excluded from the study:
- Lung disease
- Angina with minimal exertion
- Pregnancy
- Have or have had cancer other than lung cancer
- Worked in the mining Industry
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Waterbury Pulmonary Associates LLCWaterbury, Connecticut
- Meridian HealthNeptune City, New Jersey
- Atlantic Respiratory InstituteSummit, New Jersey
- Radiology Associates of AlbuquerqueAlbuquerque, New Mexico
- bioAffinity TechnologiesSan Antonio, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 27, 2023. Always confirm current availability with the study team.