Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03239834 |
| Other study ID # |
VIG-001 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 7, 2017 |
| Est. completion date |
December 20, 2020 |
Study information
| Verified date |
August 2021 |
| Source |
Vigilant Biosciences, Inc. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
