Collection of Sputum and Labeling for Lung Cancer

July 25, 2023 updated by: bioAffinity Technologies Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This study will be performed at multiple study centers to collect sputum samples from three cohorts including (1) healthy Participants, (2) individuals at high risk for lung cancer and (3) individuals who have been diagnosed with lung cancer. Participants in the high risk cohort will undergo low dose computed tomography (LDCT) scans to confirm they do not have lung cancer. LDCT scans will be evaluated by a radiologist at each site. Each subject's sputum specimen will be processed in accordance with individual experimental protocol at the laboratory of bioAffinity Technologies, Inc. (BA) located at the University of Texas at San Antonio 1604 main campus in San Antonio, Texas, or at the Research DX laboratory in Irvine, California.

Once a sample is obtained and delivered to the laboratory, the Assay methodology consists of chemical dissociation of sputum to produce a single cell suspension sample that is labeled with antibodies to identify various types of cell populations in the sample. Thereafter, sputum samples are stained with the cancer detection compound, CyPath® Lung. This compound has a unique fluorescent spectrum that can be analyzed by a flow cytometer. The flow cytometric analysis confirms that the sample is from the deep lung and identifies various cell populations based on characteristics such as cell size, granularity, and antigen expression. Cancer samples can be distinguished from non-cancer samples by the presence of highly fluorescent cells labeled by CyPath®. In this manner, CyPath® can identify lung cancer cells and other distinguishing cells that have been sloughed off in the lungs and coughed up in the sputum sample, including cancer cells.

Researchers who will be blinded as to the Participant's identity will perform the experiments that compare the characteristics of samples collected by the alternate sample collection methods and labeled by CyPath® Lung. In the latter phase of the study, the analytical results of sputum sample analysis requires that the researchers be blinded to the classification of the sputum sample and methods of collection.

Findings from the CyPath® Lung Assay will not be used in the diagnosis of Participants or subsequent treatment decisions.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Completed
        • Waterbury Pulmonary Associates LLC
    • New Jersey
      • Berkeley Heights, New Jersey, United States, 07922
        • Withdrawn
        • Summit Medical Group
      • Summit, New Jersey, United States, 07901
        • Recruiting
        • Atlantic Respiratory Institute
        • Contact:
        • Principal Investigator:
          • Robert Sussman, MD
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Recruiting
        • Radiology Associates of Albuquerque
        • Contact:
        • Principal Investigator:
          • Eugenio Rivera, MD
    • New York
      • New York, New York, United States, 10029
        • Completed
        • Department of Medicine-Clinical Trials Office - Icahn School of Medicine at Mount Sinai
    • Tennessee
      • Cookeville, Tennessee, United States, 38501
        • Terminated
        • Cookeville Regional Medical Center - Cancer Center
    • Texas
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • South Texas Veterans Health Care System (STVHCS)/Audie L. Murphy Memorial Veterans Hospital
        • Contact:
        • Principal Investigator:
          • Sheila Habib, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

Description

Inclusion Criteria:

Each subject must meet the following criteria to be enrolled in this study:

  • Male or female
  • 21 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of Differential Characteristics
Time Frame: 320 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sputum Collection Methodology
Time Frame: 320 days
The secondary endpoint is evaluation of the suitability of sputum samples collected by the three different methods.
320 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

bioAffinity Technologies Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

March 1, 2018

First Submitted That Met QC Criteria

March 1, 2018

First Posted (Actual)

March 7, 2018

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 25, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BA-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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