Clinical Evaluation of the OncAlert RAPID in Subjects Presenting for Evaluation and/or Initial Biopsy; Impact on Decision-Making

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Brief Title

Clinical Evaluation of the OncAlert RAPID in Subjects Presenting for Evaluation and/or Initial Biopsy; Impact on Decision-Making

Official Title

Clinical Evaluation of the OncAlert RAPID; Impact on Decision-Making

Brief Summary

      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.

Detailed Description

      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.

Study Type

Observational

Primary Outcome

Association of RAPID results with oral cavity / oropharyngeal biopsy.

Condition

Palatal Neoplasms

Intervention

OncAlert

Study Arms / Comparison Groups

 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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

893

Start Date

September 7, 2017

Completion Date

December 20, 2020

Primary Completion Date

August 24, 2020

Eligibility Criteria

        Inclusion Criteria:

          -  23 years of age or older

          -  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.

          -  The subject must be able to comprehend and sign an approved Informed Consent Form and
             other applicable study documents.

          -  Patients are eligible regardless of race, gender, and ethnicity

        Exclusion Criteria:

          -  Prior history and/or diagnosis of any HN cancer/HNSCC of the oral cavity, oropharynx,
             or hypopharynx including nasopharyngeal carcinoma.

          -  Prior treatment of HN cancer / HNSCC of the oral cavity, oropharynx, or hypopharynx
             including nasopharyngeal carcinoma.

          -  Prior history of a positive biopsy of the oral cavity or oropharynx.

          -  Planned excisional biopsy for a pathology diagnosis of HNSCC

          -  Clinical presentation without localizing findings

          -  Prior history of a salivary gland tumor

          -  Current and or prior diagnosis of cancer (note: other than basal and squamous cell
             carcinoma of the skin) within the past 5 years.

          -  Pregnant

Gender

All

Ages

23 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT03239834

Organization ID

VIG-001

Responsible Party

Sponsor

Study Sponsor

Vigilant Biosciences, Inc.

Collaborators

 Pearl Pathways

Study Sponsor

, ,

Verification Date

August 2021