<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/NCT03239834</url>
  </required_header>
  <id_info>
    <org_study_id>VIG-001</org_study_id>
    <nct_id>NCT03239834</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of the OncAlert RAPID in Subjects Presenting for Evaluation and/or Initial Biopsy; Impact on Decision-Making</brief_title>
  <official_title>Clinical Evaluation of the OncAlert RAPID; Impact on Decision-Making</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vigilant Biosciences, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pearl Pathways</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Vigilant Biosciences, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objectives Validate the OncAlert® RAPID Test by demonstrating that NPV &gt; (1 -prevalence).&#xD;
&#xD;
      Evaluate the independent and associated contribution of readily available clinical variables&#xD;
      including age, race, gender, HPV status, socioeconomic level, tobacco, and alcohol use with&#xD;
      the biopsy and test results.&#xD;
&#xD;
      Evaluate OncAlert® RAPID Test results in patients without immediate biopsy, both at baseline&#xD;
      and scheduled follow-up visit (approximately 1-3 months±14 days), to assess impact on&#xD;
      outcome.&#xD;
&#xD;
      Planned Number of Subjects A total enrollment of up to 1000 individuals is projected with 600&#xD;
      as the minimum accrued. Patients in the primary cohort (1a and 1b) will be followed until&#xD;
      pathology of clinically directed incisional / diagnostic biopsy pathology report is received.&#xD;
&#xD;
      Up to 200 'non-biopsy subjects' will be followed during a 1-3 month ±14 days clinic visit.&#xD;
&#xD;
      Patient Population&#xD;
&#xD;
      Cohorts 1a and 1b:&#xD;
&#xD;
      Subjects with a clinical suspicion of oral potentially malignant disorders, oral or&#xD;
      oropharyngeal cancer, or both based in part on clinical examination, symptoms, clinical&#xD;
      history, suspicious lesion(s) in mouth without history of a prior positive biopsy. Even if&#xD;
      the suspicion is low for cancer or precancer, the patient is eligible if a biopsy is&#xD;
      performed, in part, to rule this out. For example, if a subject has findings on imaging, or&#xD;
      worrisome localizing symptoms in the oral cavity or oropharynx, they would be eligible. In&#xD;
      addition, subjects with papillomas or other findings where there is a low level of concern,&#xD;
      but cancer is still in the differential, are also eligible.&#xD;
&#xD;
        -  Cohort 1a: oral cavity&#xD;
&#xD;
        -  Cohort 1b: oropharynx&#xD;
&#xD;
      Cohort 2:&#xD;
&#xD;
      Subjects are enrolled with a clinical suspicion of oral potentially malignant disorders, oral&#xD;
      or oropharyngeal cancer, or both based in part on clinical examination, symptoms, clinical&#xD;
      history, suspicious lesion(s) in mouth without history of a prior positive biopsy; however,&#xD;
      based on clinical impression and or patient related issues no immediate biopsy is obtained.&#xD;
&#xD;
      Screen Fail Rate: A 20% Screen Fail Rate is anticipated.&#xD;
&#xD;
      Investigational Product Name: OncAlert Oral Cancer RAPID Test (OncAlert RAPID)&#xD;
&#xD;
      Methodology Overview&#xD;
&#xD;
      Prospectively collect 5cc of normal saline after a combination of swish, gargle and spit into&#xD;
      the provided collection specimen cup. Specimens will be collected at baseline (time of&#xD;
      biopsy) as per standard practice at each site. The OncAlert RAPID Test cassette is inserted&#xD;
      into the specimen cup and read directly from the cassette in 10 minutes. In addition,&#xD;
      comprehensive clinical - pathology and patient demographic features including age, gender,&#xD;
      race, ethnicity, and all pathology biopsy results will be collected. Any pertinent additional&#xD;
      clinical data including HPV status, socioeconomic status, smoking, drinking history, and&#xD;
      pertinent features related to oral health will be obtained. A central pathology review for&#xD;
      all biopsy results will be performed and incorporated into the final analyses.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Overview&#xD;
&#xD;
      The OncAlert Oral Cancer RAPID Test (OncAlert RAPID) is a qualitative point-of-care lateral&#xD;
      flow assay to aid in the decision to biopsy in patients with clinical features associated&#xD;
      with oral potentially malignant disorders and or oral/oropharyngeal cancer (i.e. head and&#xD;
      neck squamous cell carcinoma).&#xD;
&#xD;
      Proposed Intended Use Statement&#xD;
&#xD;
      The device measures soluble CD44 and total protein in saliva samples collected in saline. The&#xD;
      test is an adjunct to the biopsy decision process, and not intended as a screening or&#xD;
      stand-alone diagnostic assay. To be used in adults 23 years and older. Not intended for use&#xD;
      in pregnant women.&#xD;
&#xD;
      STUDY OBJECTIVES&#xD;
&#xD;
      The principal objectives of this study are to:&#xD;
&#xD;
        -  Validate the OncAlert RAPID Test, with an NPV ≥ (1-prevalence),&#xD;
&#xD;
        -  Evaluate OncAlert RAPID Test results in patients without immediate biopsy, both at&#xD;
           baseline and scheduled follow-up visit (approximately 1-3 months), to assess impact on&#xD;
           outcome,&#xD;
&#xD;
        -  Evaluate the independent and associated contribution of readily available clinical&#xD;
           variables including age, race, gender, HPV status, socioeconomic level, tobacco, and&#xD;
           alcohol use with the biopsy and test results.&#xD;
&#xD;
      STUDY OVERVIEW&#xD;
&#xD;
      Study Approach&#xD;
&#xD;
      Prospectively collect 5cc of normal saline after a combination of swish, gargle and spit into&#xD;
      the provided collection specimen cup. 1cc will be removed and sequestered for subsequent&#xD;
      downstream analyses (Section 7). Specimens will be collected at baseline (time of biopsy) as&#xD;
      per standard practice at each site. The OncAlert RAPID Test cassette is inserted into the&#xD;
      specimen cup and read directly from the cassette in 10 minutes. In addition, acquire&#xD;
      comprehensive clinical - pathology and patient demographic features including age, gender,&#xD;
      race, ethnicity, and all pathology biopsy results. Also, obtain any pertinent additional&#xD;
      clinical data including HPV status, socioeconomic status, smoking, drinking history, and&#xD;
      pertinent features related to oral health. It is presumed that some patients within the&#xD;
      current biopsy protocol will undergo treatment as a result of the biopsy diagnosis. The&#xD;
      clinical-pathology data, when accessible, for these patients will be collected for subsequent&#xD;
      secondary analyses. A central pathology review for all biopsy results will be performed and&#xD;
      incorporated into the final analyses.&#xD;
&#xD;
      Study Duration&#xD;
&#xD;
      For Cohorts 1a and 1b patients, the pathology results of clinically directed incisional /&#xD;
      diagnostic biopsy will be followed until finalized and received.&#xD;
&#xD;
      Cohort 2 patients not having an initial incisional / diagnostic biopsy at the initial visit&#xD;
      will have an additional OncAlert® RAPID test performed within 1 -3 months±14 days (or as&#xD;
      defined by standard of care (SOC)after the initial visit.)&#xD;
&#xD;
      The study will conclude after all data is collected and analyzed. This could vary from 12 to&#xD;
      36 months or more depending on accrual rates at the open sites and other factors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 7, 2017</start_date>
  <completion_date type="Actual">December 20, 2020</completion_date>
  <primary_completion_date type="Actual">August 24, 2020</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Association of RAPID results with oral cavity / oropharyngeal biopsy.</measure>
    <time_frame>18 months</time_frame>
    <description>The likelihood of a positive biopsy was determined when either the presence of a CD44 band or Total Protein above a specific gradient were positive.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Association of RAPID results with the clinical decision process for avoiding an immediate biopsy.</measure>
    <time_frame>18 months</time_frame>
    <description>Evaluate OncAlert RAPID results in patients without immediate biopsy, both at baseline and repeat results at scheduled follow-up visit (approximately 1-3 months). If biopsy performed associate RAPID positive vs. negative results with biopsy outcome. If not biopsy is performed, compare results with clinical decision for not to biopsy.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">893</enrollment>
  <condition>Palatal Neoplasms</condition>
  <condition>Lip Neoplasm</condition>
  <condition>Gingival Neoplasms</condition>
  <condition>Leukoplakia, Oral</condition>
  <condition>Tongue Neoplasms</condition>
  <condition>Oropharyngeal Neoplasms</condition>
  <condition>Oral Ulcer</condition>
  <arm_group>
    <arm_group_label>OncAlert RAPID test in oral cavity biopsy patients.</arm_group_label>
    <description>Patients at an intermediate and high level of clinical risk for HNSCC and scheduled for initial and immediate incisional diagnostic biopsy of their Oral Cavity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OncAlert RAPID test in oropharyngeal biopsy patients.</arm_group_label>
    <description>Patients at an intermediate to high level of clinical risk for HNSCC and scheduled for initial and immediate incisional diagnostic biopsy of their Oropharnyx</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OncAlert RAPID test in clinical decision to biopsy.</arm_group_label>
    <description>Patients at a lower level of clinical risk for HNSCC and not scheduled for an immediate biopsy. Patients will be offered medical management and have an initial RAPID test. All patients will return within 1-3 months for follow-up test and a possible biopsy if clinically indicated.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>OncAlert</intervention_name>
    <description>A noninvasive point of care salivary rinse test performed as 1) a one-time test for patients presenting with suspicion of OPMD and scheduled for biopsy and 2) a multi-administered test for patients presenting with suspicious lesions not scheduled for biopsy.</description>
    <arm_group_label>OncAlert RAPID test in clinical decision to biopsy.</arm_group_label>
    <arm_group_label>OncAlert RAPID test in oral cavity biopsy patients.</arm_group_label>
    <arm_group_label>OncAlert RAPID test in oropharyngeal biopsy patients.</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        For the current study cohort,we anticipate working with 20 or more institutions to obtain&#xD;
        oral rinse saliva samples from up to 1000patients (most patients scheduled for biopsyof the&#xD;
        oral cavity or oropharynx and not more than 200 non-biopsy patients) from different&#xD;
        geographic regions.&#xD;
&#xD;
        The study population will be representative of adults at least 23 years of age who have&#xD;
        been diagnosed as described in inclusion criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  23 years of age or older&#xD;
&#xD;
          -  A clinical suspicion of oral potentially malignant disorders, oral or oropharyngeal&#xD;
             cancer, or both based in part on clinical examination, symptoms, clinical history,&#xD;
             suspicious lesion(s) in mouth without history of a prior positive biopsy.&#xD;
&#xD;
          -  The subject must be able to comprehend and sign an approved Informed Consent Form and&#xD;
             other applicable study documents.&#xD;
&#xD;
          -  Patients are eligible regardless of race, gender, and ethnicity&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior history and/or diagnosis of any HN cancer/HNSCC of the oral cavity, oropharynx,&#xD;
             or hypopharynx including nasopharyngeal carcinoma.&#xD;
&#xD;
          -  Prior treatment of HN cancer / HNSCC of the oral cavity, oropharynx, or hypopharynx&#xD;
             including nasopharyngeal carcinoma.&#xD;
&#xD;
          -  Prior history of a positive biopsy of the oral cavity or oropharynx.&#xD;
&#xD;
          -  Planned excisional biopsy for a pathology diagnosis of HNSCC&#xD;
&#xD;
          -  Clinical presentation without localizing findings&#xD;
&#xD;
          -  Prior history of a salivary gland tumor&#xD;
&#xD;
          -  Current and or prior diagnosis of cancer (note: other than basal and squamous cell&#xD;
             carcinoma of the skin) within the past 5 years.&#xD;
&#xD;
          -  Pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>23 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dr. Joel Epstein</name>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <zip>90211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Biosolutions Clinical Research Center</name>
      <address>
        <city>La Mesa</city>
        <state>California</state>
        <zip>91941</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Loma Linda School of Dentistry</name>
      <address>
        <city>Loma Linda</city>
        <state>California</state>
        <zip>92350</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tower ENT, based at Cedars Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sacramento ENT</name>
      <address>
        <city>Roseville</city>
        <state>California</state>
        <zip>95661</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sacramento ENT</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95815</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UConn Dental Medicine</name>
      <address>
        <city>Farmington</city>
        <state>Connecticut</state>
        <zip>06030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami Health Systems</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENT of South Florida Plantation</name>
      <address>
        <city>Plantation</city>
        <state>Florida</state>
        <zip>33324</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENT of South Florida Port St. Lucie</name>
      <address>
        <city>Port Saint Lucie</city>
        <state>Florida</state>
        <zip>34952</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asclepes Research</name>
      <address>
        <city>Weeki Wachee</city>
        <state>Florida</state>
        <zip>34607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chicago ENT</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60657</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heartland Medical Research</name>
      <address>
        <city>Clive</city>
        <state>Iowa</state>
        <zip>50325</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Maryland</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tufts University</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston University Dental School</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMKC School of Dentistry</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke Head and Neck Surgery &amp; Communication Services</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eastern Carolina University School of Dental Medicine</name>
      <address>
        <city>Greenville</city>
        <state>North Carolina</state>
        <zip>27834</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Piedmont Ear, Nose and Throat Associates</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Specialty Physician Associates</name>
      <address>
        <city>Bethlehem</city>
        <state>Pennsylvania</state>
        <zip>18017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Tennessee</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38163</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fort Worth ENT</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Berkson Medical, LLC</name>
      <address>
        <city>Mansfield</city>
        <state>Texas</state>
        <zip>76063</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chrysalis Clinical Research</name>
      <address>
        <city>Saint George</city>
        <state>Utah</state>
        <zip>84790</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 19, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2017</study_first_posted>
  <last_update_submitted>August 11, 2021</last_update_submitted>
  <last_update_submitted_qc>August 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Leukoplakia</mesh_term>
    <mesh_term>Oropharyngeal Neoplasms</mesh_term>
    <mesh_term>Leukoplakia, Oral</mesh_term>
    <mesh_term>Tongue Neoplasms</mesh_term>
    <mesh_term>Lip Neoplasms</mesh_term>
    <mesh_term>Palatal Neoplasms</mesh_term>
    <mesh_term>Gingival Neoplasms</mesh_term>
    <mesh_term>Oral Ulcer</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/NCT03239834
org study id: VIG-001
nct id: NCT03239834
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
Objectives Validate the OncAlert® RAPID Test by demonstrating that NPV > (1 -prevalence).

      Evaluate the independent and associated contribution of readily available clinical variables
      including age, race, gender, HPV status, socioeconomic level, tobacco, and alcohol use with
      the biopsy and test results.

      Evaluate OncAlert® RAPID Test results in patients without immediate biopsy, both at baseline
      and scheduled follow-up visit (approximately 1-3 months±14 days), to assess impact on
      outcome.

      Planned Number of Subjects A total enrollment of up to 1000 individuals is projected with 600
      as the minimum accrued. Patients in the primary cohort (1a and 1b) will be followed until
      pathology of clinically directed incisional / diagnostic biopsy pathology report is received.

      Up to 200 'non-biopsy subjects' will be followed during a 1-3 month ±14 days clinic visit.

      Patient Population

      Cohorts 1a and 1b:

      Subjects with a clinical suspicion of oral potentially malignant disorders, oral or
      oropharyngeal cancer, or both based in part on clinical examination, symptoms, clinical
      history, suspicious lesion(s) in mouth without history of a prior positive biopsy. Even if
      the suspicion is low for cancer or precancer, the patient is eligible if a biopsy is
      performed, in part, to rule this out. For example, if a subject has findings on imaging, or
      worrisome localizing symptoms in the oral cavity or oropharynx, they would be eligible. In
      addition, subjects with papillomas or other findings where there is a low level of concern,
      but cancer is still in the differential, are also eligible.

        -  Cohort 1a: oral cavity

        -  Cohort 1b: oropharynx

      Cohort 2:

      Subjects are enrolled with a clinical suspicion of oral potentially malignant disorders, oral
      or oropharyngeal cancer, or both based in part on clinical examination, symptoms, clinical
      history, suspicious lesion(s) in mouth without history of a prior positive biopsy; however,
      based on clinical impression and or patient related issues no immediate biopsy is obtained.

      Screen Fail Rate: A 20% Screen Fail Rate is anticipated.

      Investigational Product Name: OncAlert Oral Cancer RAPID Test (OncAlert RAPID)

      Methodology Overview

      Prospectively collect 5cc of normal saline after a combination of swish, gargle and spit into
      the provided collection specimen cup. Specimens will be collected at baseline (time of
      biopsy) as per standard practice at each site. The OncAlert RAPID Test cassette is inserted
      into the specimen cup and read directly from the cassette in 10 minutes. In addition,
      comprehensive clinical - pathology and patient demographic features including age, gender,
      race, ethnicity, and all pathology biopsy results will be collected. Any pertinent additional
      clinical data including HPV status, socioeconomic status, smoking, drinking history, and
      pertinent features related to oral health will be obtained. A central pathology review for
      all biopsy results will be performed and incorporated into the final analyses.
Overview

      The OncAlert Oral Cancer RAPID Test (OncAlert RAPID) is a qualitative point-of-care lateral
      flow assay to aid in the decision to biopsy in patients with clinical features associated
      with oral potentially malignant disorders and or oral/oropharyngeal cancer (i.e. head and
      neck squamous cell carcinoma).

      Proposed Intended Use Statement

      The device measures soluble CD44 and total protein in saliva samples collected in saline. The
      test is an adjunct to the biopsy decision process, and not intended as a screening or
      stand-alone diagnostic assay. To be used in adults 23 years and older. Not intended for use
      in pregnant women.

      STUDY OBJECTIVES

      The principal objectives of this study are to:

        -  Validate the OncAlert RAPID Test, with an NPV ≥ (1-prevalence),

        -  Evaluate OncAlert RAPID Test results in patients without immediate biopsy, both at
           baseline and scheduled follow-up visit (approximately 1-3 months), to assess impact on
           outcome,

        -  Evaluate the independent and associated contribution of readily available clinical
           variables including age, race, gender, HPV status, socioeconomic level, tobacco, and
           alcohol use with the biopsy and test results.

      STUDY OVERVIEW

      Study Approach

      Prospectively collect 5cc of normal saline after a combination of swish, gargle and spit into
      the provided collection specimen cup. 1cc will be removed and sequestered for subsequent
      downstream analyses (Section 7). Specimens will be collected at baseline (time of biopsy) as
      per standard practice at each site. The OncAlert RAPID Test cassette is inserted into the
      specimen cup and read directly from the cassette in 10 minutes. In addition, acquire
      comprehensive clinical - pathology and patient demographic features including age, gender,
      race, ethnicity, and all pathology biopsy results. Also, obtain any pertinent additional
      clinical data including HPV status, socioeconomic status, smoking, drinking history, and
      pertinent features related to oral health. It is presumed that some patients within the
      current biopsy protocol will undergo treatment as a result of the biopsy diagnosis. The
      clinical-pathology data, when accessible, for these patients will be collected for subsequent
      secondary analyses. A central pathology review for all biopsy results will be performed and
      incorporated into the final analyses.

      Study Duration

      For Cohorts 1a and 1b patients, the pathology results of clinically directed incisional /
      diagnostic biopsy will be followed until finalized and received.

      Cohort 2 patients not having an initial incisional / diagnostic biopsy at the initial visit
      will have an additional OncAlert® RAPID test performed within 1 -3 months±14 days (or as
      defined by standard of care (SOC)after the initial visit.)

      The study will conclude after all data is collected and analyzed. This could vary from 12 to
      36 months or more depending on accrual rates at the open sites and other factors.
observational model: Cohort
time perspective: Prospective
measure: Association of RAPID results with oral cavity / oropharyngeal biopsy.
time frame: 18 months
description: The likelihood of a positive biopsy was determined when either the presence of a CD44 band or Total Protein above a specific gradient were positive.
measure: Association of RAPID results with the clinical decision process for avoiding an immediate biopsy.
time frame: 18 months
description: Evaluate OncAlert RAPID results in patients without immediate biopsy, both at baseline and repeat results at scheduled follow-up visit (approximately 1-3 months). If biopsy performed associate RAPID positive vs. negative results with biopsy outcome. If not biopsy is performed, compare results with clinical decision for not to biopsy.
arm group label: OncAlert RAPID test in oral cavity biopsy patients.
description: Patients at an intermediate and high level of clinical risk for HNSCC and scheduled for initial and immediate incisional diagnostic biopsy of their Oral Cavity.
arm group label: OncAlert RAPID test in oropharyngeal biopsy patients.
description: Patients at an intermediate to high level of clinical risk for HNSCC and scheduled for initial and immediate incisional diagnostic biopsy of their Oropharnyx
arm group label: OncAlert RAPID test in clinical decision to biopsy.
description: Patients at a lower level of clinical risk for HNSCC and not scheduled for an immediate biopsy. Patients will be offered medical management and have an initial RAPID test. All patients will return within 1-3 months for follow-up test and a possible biopsy if clinically indicated.
intervention type: Device
intervention name: OncAlert
description: A noninvasive point of care salivary rinse test performed as 1) a one-time test for patients presenting with suspicion of OPMD and scheduled for biopsy and 2) a multi-administered test for patients presenting with suspicious lesions not scheduled for biopsy.
arm group label: OncAlert RAPID test in clinical decision to biopsy.
arm group label: OncAlert RAPID test in oral cavity biopsy patients.
arm group label: OncAlert RAPID test in oropharyngeal biopsy patients.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 23 Years
maximum age: N/A
healthy volunteers: No
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country: United States
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Leukoplakia
mesh term: Oropharyngeal Neoplasms
mesh term: Leukoplakia, Oral
mesh term: Tongue Neoplasms
mesh term: Lip Neoplasms
mesh term: Palatal Neoplasms
mesh term: Gingival Neoplasms
mesh term: Oral Ulcer
sharing ipd: No