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

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ClinicalTrials.gov Identifier: NCT03837600
Recruitment Status : Completed
First Posted : February 12, 2019
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
bioAffinity Technologies Inc.

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.


Condition or disease
Lung Cancer

Detailed Description:

A clinical study was completed to determine the clinical sensitivity and specificity of the CyPath® Early Lung Cancer Detection Assay (the "Assay") by comparing sputum specimens from three cohorts of Participants including healthy individuals, individuals at high risk for lung cancer and individuals diagnosed with lung cancer. Results were published in the Journal of Thoracic Oncology- see reference. Research now is planned to optimize the Assay as described below. Therefore, collection and analysis of sputum samples from three cohorts including healthy Participants, high risk Participants and cancer patient Participants are needed to conduct continuing research leading to optimization of the Assay.

This study will be performed at multiple study centers to collect sputum samples from three cohorts including healthy Participants who have no known lung disease, individuals at high risk for lung cancer and individuals at high risk for lung cancer who have been diagnosed with lung cancer. The sputum samples will be collected at the study site or at the Participant's home after explanation of the collection procedure by study staff. Samples will be identified with an identification number blinding the sample identity. However, the cohort classification of the sputum sample will be known by the Researcher as required to conduct the experiments. In the latter phase of the study that requires comparison of results between cohorts, researchers will be blinded to the classification of the sputum sample. 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. The BA laboratory will process each sputum sample for use in optimizing the Assay. bioAffinity researchers who will be blinded as to the Participant's identity will perform the 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 cell count in sputum, as described below. In the latter phase of the study, the analytical results of sputum sample analysis requires that the researchers will be blinded to the classification of the sputum sample. To ensure sample adequacy as it relates to its collection for the 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.

Later optimization efforts including the comparative study will require that participants in the high-risk cohort undergo low dose computed tomography (LDCT) scans to confirm they do not have lung cancer. LDCT scans will be evaluated by a licensed, independent radiologist who may advise the participant to seek additional medical advice if warranted by LDCT imaging. Participants in the cancer cohort will have undergone LDCT scans identifying them as likely to have lung cancer prior to sample collection. Findings from the CyPath® Early Lung Cancer Detection Assay will not be used in the diagnosis of Participants or subsequent treatment decisions.


Study Type : Observational
Actual Enrollment : 197 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Sputum Labeling Utilizing Synthetic Meso-Tetra (4-Carboxyphenyl) Porphyrin (TCPP) for Detection of Lung Cancer
Actual Study Start Date : September 22, 2016
Actual Primary Completion Date : August 15, 2018
Actual Study Completion Date : August 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Group/Cohort
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.



Primary Outcome Measures :
  1. Assay Optimization [ Time Frame: 320 days ]
    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.


Secondary Outcome Measures :
  1. Identification of Differential Characteristics [ Time Frame: 320 days ]
    Further optimization efforts including the comparative study will require that participants in the high-risk cohort undergo low dose computed tomography (LDCT) scans to confirm they do not have lung cancer. LDCT scans will be evaluated by a licensed, independent radiologist who may advise the participant to seek additional medical advice if warranted by LDCT imaging. Participants in the cancer cohort will have undergone LDCT scans identifying them as likely to have lung cancer prior to sample collection. Findings from the CyPath® Early Lung Cancer Detection Assay will not be used in the diagnosis of Participants or subsequent treatment decisions but provide comparative characteristics and correlation of sputum results between the three cohorts previously described between cohort samples and CyPath® Early Lung Cancer Detection Assay results



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03837600


Locations
United States, Connecticut
Waterbury Pulmonary Associates LLC
Waterbury, Connecticut, United States, 06708
United States, New Jersey
Meridian Health
Neptune, New Jersey, United States, 07753
Atlantic Respiratory Institute
Summit, New Jersey, United States, 07901
United States, New Mexico
Radiology Associates of Albuquerque
Albuquerque, New Mexico, United States, 87109
United States, Texas
bioAffinity Technologies
San Antonio, Texas, United States, 78249
Sponsors and Collaborators
bioAffinity Technologies Inc.
Investigators
Principal Investigator: Vivienne Rebel, MD,PhD bioAffinity Technologies

Publications of Results:
Responsible Party: bioAffinity Technologies Inc.
ClinicalTrials.gov Identifier: NCT03837600     History of Changes
Other Study ID Numbers: BA-001
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by bioAffinity Technologies Inc.:
LDCT
Sputum
High-risk Smoker
Porphyrin
Early detection

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases