Sputum Labeling Utilizing Synthetic Meso-Tetra (4-Carboxyphenyl) Porphyrin (TCPP) for Detection of Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Observational

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.
    

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.
    

Observational model: Cohort
Time perspective: Other
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
      
Keywords: LDCT; Sputum; High-risk Smoker; Porphyrin; Early detection