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Trial record 4 of 24 for:    Porphyrins

Collection of Sputum and Labeling for Lung Cancer

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ClinicalTrials.gov Identifier: NCT03457415
Recruitment Status : Recruiting
First Posted : March 7, 2018
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
bioAffinity Technologies Inc.

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.


Condition or disease
Lung Cancer

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.


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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Collection of Sputum and Sputum Labeling Utilizing Synthetic Meso-Tetra (4-Carboxyphenyl) Porphyrin (TCPP) for Detection of Lung Cancer
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Sputum Collection Methodology [ Time Frame: 320 days ]
    The secondary endpoint is evaluation of the suitability of sputum samples collected by the three different methods.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

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
Criteria

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

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): NCT03457415


Contacts
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Contact: Maria Zannes, JD 505-400-9747 mz@bioaffinitytech.com
Contact: Xavier Reveles, MS 210-698-5334 xr@bioaffinitytech.com

Locations
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United States, Connecticut
Waterbury Pulmonary Associates LLC Recruiting
Waterbury, Connecticut, United States, 06708
Contact: Michele Anderson, LPN    203-759-3656    michelea@waterburypulmonary.com   
Principal Investigator: David G. Hill, MD         
United States, New Jersey
Summit Medical Group Recruiting
Berkeley Heights, New Jersey, United States, 07922
Contact: Kelly Ritter, LPN    908-721-5673    kritter@smgnj.com   
Principal Investigator: Sarada Gurubhagavatula, MD         
Atlantic Respiratory Institute Recruiting
Summit, New Jersey, United States, 07901
Contact: Marissa Rienton-Lim, CCRC    908-934-0440    marissa.rienton-lim@atlantichealth.org   
Principal Investigator: Robert Sussman, MD         
United States, New Mexico
Radiology Associates of Albuquerque Recruiting
Albuquerque, New Mexico, United States, 87109
Contact: Timothy P. Zannes, JD    505-506-0853    tz@bioaffinitytech.com   
Principal Investigator: Kathleen Lopez, MD         
United States, New York
Department of Medicine-Clinical Trials Office - Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Diana Chispe-Valerio, BS    212-241-9538    diana.valerio@mssm.edu   
Principal Investigator: Louis R DePalo, MD         
United States, Tennessee
Cookeville Regional Medical Center - Cancer Center Recruiting
Cookeville, Tennessee, United States, 38501
Contact: Tellie Mullinix, RN    931-783-2256    tymullinix@crmchealth.org   
Principal Investigator: Paul Jacquin, MD         
United States, Texas
South Texas Veterans Health Care System (STVHCS)/Audie L. Murphy Memorial Veterans Hospital Recruiting
San Antonio, Texas, United States, 78229
Contact: Alexander Aguilera    210-834-1344    aguileraa4@uthscsa.edu   
Principal Investigator: Sheila Habib, MD         
Sponsors and Collaborators
bioAffinity Technologies Inc.

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Responsible Party: bioAffinity Technologies Inc.
ClinicalTrials.gov Identifier: NCT03457415     History of Changes
Other Study ID Numbers: BA-002
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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