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

NCT03837600 | Completed

• 1 other identifier: BA-001
• Study Type: observational
• Target: 197
• Locations: 1 country
• Sites: 5

Brief 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

Lung Cancer

Keywords

LDCT; Sputum; High-risk Smoker; Porphyrin; Early detection

Outcome Measures

Primary Outcomes (1)

• Assay Optimization

  Assay optimization for methods to liquefy sputum by chemical dissociation, select proper fixatives and buffers, the efficacy of use of methyl-beta-cyclodextrin (MBCD) in sputum processing and determine the cell count in sputum. To ensure sample adequacy as deep lung, samples will be analyzed by a cytologist who will perform PAP staining for the presence of macrophages. Macrophages are an indication that the sputum sample is from deep within the lungs. Findings of the experiments and comparative study will not be used in the diagnosis or treatment of Participants.

  320 days

Secondary Outcomes (1)

• Identification of Differential Characteristics

  320 days

Study Arms (3)

Healthy Cohort

Participants who have smoked less than 5 pack-years, have quit smoking for more than 15 years and have no known lung diseases.

High-risk Cohort

Participants who are at high risk for lung cancer including current smokers who have smoked for more than 30 pack-years and have not quit within 15 years.

Cancer Cohort

Participants who have been diagnosed with lung cancer.

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Up to 200 Participants will be recruited, 21 years of age or older of both sexes and all racial distributions. Participants must meet the exclusion criteria and inclusion criteria detailed under inclusion/exclusion criteria

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

Sponsors & Collaborators

• bioAffinity Technologies Inc.: lead

Study Sites (5)

Waterbury Pulmonary Associates LLC

Waterbury, Connecticut, 06708, United States

Location

Meridian Health

Neptune City, New Jersey, 07753, United States

Location

Atlantic Respiratory Institute

Summit, New Jersey, 07901, United States

Location

Radiology Associates of Albuquerque

Albuquerque, New Mexico, 87109, United States

Location

bioAffinity Technologies

San Antonio, Texas, 78249, United States

Location

Related Publications (1)

• Patriquin L, Merrick DT, Hill D, Holcomb RG, Lemieux ME, Bennett G, Karia B, Rebel VI, Bauer T 2nd. Early Detection of Lung Cancer with Meso Tetra (4-Carboxyphenyl) Porphyrin-Labeled Sputum. J Thorac Oncol. 2015 Sep;10(9):1311-1318. doi: 10.1097/JTO.0000000000000627.

  PMID: 26200451 RESULT

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Vivienne Rebel, MD,PhD

  bioAffinity Technologies

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2019
• First Posted: February 12, 2019
• Study Start: September 22, 2016
• Primary Completion: August 15, 2018
• Study Completion: August 15, 2018
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)