Sputum Labeling Utilizing Synthetic Meso-Tetra (4-Carboxyphenyl) Porphyrin (TCPP) for Detection of Lung Cancer

Completed

Conditions studied: Lung Cancer

In brief

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.

Key facts

Study ID

NCT03837600

Run by

bioAffinity Technologies Inc.

People needed

197

Starts

2016-09-22

Expected to finish

2018-08-15

Last updated by the study team

2023-07-27

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Waterbury Pulmonary Associates LLC — Waterbury, Connecticut, United States
• Meridian Health — Neptune City, New Jersey, United States
• Atlantic Respiratory Institute — Summit, New Jersey, United States
• Radiology Associates of Albuquerque — Albuquerque, New Mexico, United States
• bioAffinity Technologies — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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