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

NCT03837600 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 197

Last updated 2023-07-27

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • bioAffinity Technologies Inc.

    lead INDUSTRY

Principal Investigators

  • Vivienne Rebel, MD,PhD · bioAffinity Technologies

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-22
Primary Completion
2018-08-15
Completion
2018-08-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03837600 on ClinicalTrials.gov