Collection of Sputum and Labeling for Lung Cancer

NCT03457415 | Recruiting

• 1 other identifier: BA-002
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Identification of Differential Characteristics

  The primary outcome measure is to identify differential characteristics (using flow cytometry for high-throughput screening of Assay labeled sputum samples) between samples taken from healthy Participants, Participants at high risk for lung cancer who are free of the disease, and Participants with confirmed lung cancer.

  320 days

Secondary Outcomes (1)

• Sputum Collection Methodology

  320 days

Study Arms (3)

Healthy Cohort

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

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

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.

Eligibility Criteria

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

Study Population

Study Population: Male and female Participants, 21 years of age or older, who meet the requirements of one of three cohorts described below: * Healthy Cohort * High-risk Cohort * Cancer Cohort Participants who meet any of the following criteria will be excluded from the study: * Severe obstructive lung disease and unable to cough with sufficient exertion to produce a sputum sample due to lung disease. Participants with lung disease that are able to cough with sufficient exertion to produce a sputum sample are not excluded from the study. * Currently undergoing treatment for cancer. Participants who are on long-term medications used for treatment and/or prevention of cancer, such as Tamoxifen for breast cancer, are not excluded. * Angina with minimal exertion * Pregnancy

You may qualify if:

• Each subject must meet the following criteria to be enrolled in this study:
• Male or female
• 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.

You may not qualify if:

• Participants who meet any of the following criteria will be excluded from the study:
• 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
• Pregnancy

Sponsors & Collaborators

• bioAffinity Technologies Inc.: lead

Study Sites (3)

Atlantic Respiratory Institute

Summit, New Jersey, 07901, United States

RECRUITING

Radiology Associates of Albuquerque

Albuquerque, New Mexico, 87109, United States

RECRUITING

South Texas Veterans Health Care System (STVHCS)/Audie L. Murphy Memorial Veterans Hospital

San Antonio, Texas, 78229, United States

RECRUITING

Related Publications (3)

• Bederka LH, Sanchez JR, Rebeles J, Araujo PR, Grayson MH, Lai SC, DePalo LR, Habib SA, Hill DG, Lopez K, Patriquin L, Sussman R, Humphreys J, Reveles XT, Rebel VI. Sputum analysis by flow cytometry; an effective platform to analyze the lung environment. PLoS One. 2022 Aug 17;17(8):e0272069. doi: 10.1371/journal.pone.0272069. eCollection 2022.

  PMID: 35976857 BACKGROUND

• Grayson M, Lai SC, Bederka LH, Araujo P, Sanchez J, Reveles XT, Rebel VI, Rebeles J. Quality-Controlled Sputum Analysis by Flow Cytometry. J Vis Exp. 2021 Aug 9;(174). doi: 10.3791/62785.

  PMID: 34424239 BACKGROUND

• Lemieux ME, Reveles XT, Rebeles J, Bederka LH, Araujo PR, Sanchez JR, Grayson M, Lai SC, DePalo LR, Habib SA, Hill DG, Lopez K, Patriquin L, Sussman R, Joyce RP, Rebel VI. Detection of early-stage lung cancer in sputum using automated flow cytometry and machine learning. Respir Res. 2023 Jan 21;24(1):23. doi: 10.1186/s12931-023-02327-3.

  PMID: 36681813 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Maria Zannes, JD

CONTACT

505-400-9747; mz@bioaffinitytech.com

Xavier Reveles, MS

CONTACT

210-698-5334; xr@bioaffinitytech.com

Study Design

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

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: March 7, 2018
• Study Start: March 1, 2018
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)