<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03837600</url>
  </required_header>
  <id_info>
    <org_study_id>BA-001</org_study_id>
    <nct_id>NCT03837600</nct_id>
  </id_info>
  <brief_title>Sputum Labeling Utilizing Synthetic Meso-Tetra (4-Carboxyphenyl) Porphyrin (TCPP) for Detection of Lung Cancer</brief_title>
  <official_title>Sputum Labeling Utilizing Synthetic Meso-Tetra (4-Carboxyphenyl) Porphyrin (TCPP) for Detection of Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>bioAffinity Technologies Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>bioAffinity Technologies Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is optimization of the assay to discriminate between&#xD;
      cancer cells and non-cancer cells in sputum samples by the performance of experiments that&#xD;
      will determine methods to liquefy sputum, select proper fixatives and buffers, determine the&#xD;
      efficacy of use of methyl-beta-cyclodextrin (MBCD) in sputum processing and determine the use&#xD;
      of flow cytometry for high-throughput, and in the establishment of cell count and sputum cell&#xD;
      populations in patient samples.&#xD;
&#xD;
      The secondary objective of this study is comparison of the characteristics of sputum from&#xD;
      three cohorts labeled with CyPath Lung to determine differential characteristics between&#xD;
      samples taken from Participants who are not at high risk for lung cancer, Participants at&#xD;
      high risk for lung cancer who are free of the disease and Participants with confirmed lung&#xD;
      cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A clinical study was completed to determine the clinical sensitivity and specificity of the&#xD;
      CyPath® Early Lung Cancer Detection Assay (the &quot;Assay&quot;) by comparing sputum specimens from&#xD;
      three cohorts of Participants including healthy individuals, individuals at high risk for&#xD;
      lung cancer and individuals diagnosed with lung cancer. Results were published in the Journal&#xD;
      of Thoracic Oncology- see reference. Research now is planned to optimize the Assay as&#xD;
      described below. Therefore, collection and analysis of sputum samples from three cohorts&#xD;
      including healthy Participants, high risk Participants and cancer patient Participants are&#xD;
      needed to conduct continuing research leading to optimization of the Assay.&#xD;
&#xD;
      This study will be performed at multiple study centers to collect sputum samples from three&#xD;
      cohorts including healthy Participants who have no known lung disease, individuals at high&#xD;
      risk for lung cancer and individuals at high risk for lung cancer who have been diagnosed&#xD;
      with lung cancer. The sputum samples will be collected at the study site or at the&#xD;
      Participant's home after explanation of the collection procedure by study staff. Samples will&#xD;
      be identified with an identification number blinding the sample identity. However, the cohort&#xD;
      classification of the sputum sample will be known by the Researcher as required to conduct&#xD;
      the experiments. In the latter phase of the study that requires comparison of results between&#xD;
      cohorts, researchers will be blinded to the classification of the sputum sample. Each&#xD;
      subject's sputum specimen will be processed in accordance with individual experimental&#xD;
      protocol at the laboratory of bioAffinity Technologies, Inc. (BA) located at the University&#xD;
      of Texas at San Antonio 1604 main campus in San Antonio, Texas. The BA laboratory will&#xD;
      process each sputum sample for use in optimizing the Assay. bioAffinity researchers who will&#xD;
      be blinded as to the Participant's identity will perform the experiments that will determine&#xD;
      methods to liquefy sputum, select proper fixatives and buffers, determine the efficacy of use&#xD;
      of methyl-beta-cyclodextrin (MBCD) in sputum processing and determine the cell count in&#xD;
      sputum, as described below. In the latter phase of the study, the analytical results of&#xD;
      sputum sample analysis requires that the researchers will be blinded to the classification of&#xD;
      the sputum sample. To ensure sample adequacy as it relates to its collection for the deep&#xD;
      lung, samples will be analyzed by a cytologist who will perform PAP staining for the presence&#xD;
      of macrophages. Macrophages are an indication that the sputum sample is from deep within the&#xD;
      lungs. Findings of the experiments and comparative study will not be used in the diagnosis or&#xD;
      treatment of Participants.&#xD;
&#xD;
      Later optimization efforts including the comparative study will require that participants in&#xD;
      the high-risk cohort undergo low dose computed tomography (LDCT) scans to confirm they do not&#xD;
      have lung cancer. LDCT scans will be evaluated by a licensed, independent radiologist who may&#xD;
      advise the participant to seek additional medical advice if warranted by LDCT imaging.&#xD;
      Participants in the cancer cohort will have undergone LDCT scans identifying them as likely&#xD;
      to have lung cancer prior to sample collection. Findings from the CyPath® Early Lung Cancer&#xD;
      Detection Assay will not be used in the diagnosis of Participants or subsequent treatment&#xD;
      decisions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 22, 2016</start_date>
  <completion_date type="Actual">August 15, 2018</completion_date>
  <primary_completion_date type="Actual">August 15, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Assay Optimization</measure>
    <time_frame>320 days</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Identification of Differential Characteristics</measure>
    <time_frame>320 days</time_frame>
    <description>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</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">197</enrollment>
  <condition>Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Healthy Cohort</arm_group_label>
    <description>Participants who have smoked less than 5 pack-years, have quit smoking for more than 15 years and have no known lung diseases.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High-risk Cohort</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cancer Cohort</arm_group_label>
    <description>Participants who have been diagnosed with lung cancer.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Up to 200 Participants will be recruited, 21 years of age or older of both sexes and all&#xD;
        racial distributions. Participants must meet the exclusion criteria and inclusion criteria&#xD;
        detailed under inclusion/exclusion criteria&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Each subject must meet the following criteria to be enrolled in this study:&#xD;
&#xD;
          -  Male or female&#xD;
&#xD;
          -  Study Participants must be willing to provide primary care physician contact&#xD;
             information and agree to have medical information released if indicated&#xD;
&#xD;
          -  Meet requirements of one of three cohorts in the study:&#xD;
&#xD;
               -  Healthy Cohort: Current non-smoker who has smoked less than 5 pack-years in his&#xD;
                  or her lifetime, and if smoked, has quit for more than 15 years ago and who has&#xD;
                  no known lung disease.&#xD;
&#xD;
               -  High Risk Cohort: Current smoker, or individual who has quit smoking less than 15&#xD;
                  years before study start, who has smoked more than 30 pack-years in his or her&#xD;
                  lifetime.&#xD;
&#xD;
               -  Cancer Cohort: Individual who has been diagnosed by a physician with lung cancer.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Participants who meet any of the following criteria will be excluded from the study:&#xD;
&#xD;
          -  Lung disease&#xD;
&#xD;
          -  Angina with minimal exertion&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Have or have had cancer other than lung cancer&#xD;
&#xD;
          -  Worked in the mining Industry&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vivienne Rebel, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>bioAffinity Technologies</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Waterbury Pulmonary Associates LLC</name>
      <address>
        <city>Waterbury</city>
        <state>Connecticut</state>
        <zip>06708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Health</name>
      <address>
        <city>Neptune</city>
        <state>New Jersey</state>
        <zip>07753</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlantic Respiratory Institute</name>
      <address>
        <city>Summit</city>
        <state>New Jersey</state>
        <zip>07901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiology Associates of Albuquerque</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>bioAffinity Technologies</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78249</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>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.</citation>
    <PMID>26200451</PMID>
  </results_reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>January 31, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>July 25, 2023</last_update_submitted>
  <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>LDCT</keyword>
  <keyword>Sputum</keyword>
  <keyword>High-risk Smoker</keyword>
  <keyword>Porphyrin</keyword>
  <keyword>Early detection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03837600
org study id: BA-001
nct id: NCT03837600
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Other
measure: Assay Optimization
time frame: 320 days
description: 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.
measure: Identification of Differential Characteristics
time frame: 320 days
description: 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
arm group label: Healthy Cohort
description: Participants who have smoked less than 5 pack-years, have quit smoking for more than 15 years and have no known lung diseases.
arm group label: High-risk Cohort
description: 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.
arm group label: Cancer Cohort
description: Participants who have been diagnosed with lung cancer.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Vivienne Rebel, MD,PhD
role: Principal Investigator
affiliation: bioAffinity Technologies
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
citation: 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
responsible party type: Sponsor
mesh term: Lung Neoplasms
sharing ipd: No