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

Sponsor

Vigilant Biosciences, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03239834

Collaborator

Pearl Pathways (Other)

893

Enrollment

Locations

39.4

Actual Duration (Months)

34.3

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Palatal Neoplasms Lip Neoplasm Gingival Neoplasms Leukoplakia, Oral Tongue Neoplasms Oropharyngeal Neoplasms Oral Ulcer	Device: OncAlert

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 Design

Study Type:

Observational

Actual Enrollment :

893 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 7, 2017

Actual Primary Completion Date :

Aug 24, 2020

Actual Study Completion Date :

Dec 20, 2020

Arms and Interventions

Arm	Intervention/Treatment
OncAlert RAPID test in oral cavity biopsy patients. 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.	Device: OncAlert 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.
OncAlert RAPID test in oropharyngeal biopsy patients. Patients at an intermediate to high level of clinical risk for HNSCC and scheduled for initial and immediate incisional diagnostic biopsy of their Oropharnyx	Device: OncAlert 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.
OncAlert RAPID test in clinical decision to biopsy. 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.	Device: OncAlert 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

Intervention/Treatment

OncAlert RAPID test in oral cavity biopsy patients.

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.

Device: OncAlert

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.

OncAlert RAPID test in oropharyngeal biopsy patients.

Patients at an intermediate to high level of clinical risk for HNSCC and scheduled for initial and immediate incisional diagnostic biopsy of their Oropharnyx

Device: OncAlert

OncAlert RAPID test in clinical decision to biopsy.

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.

Device: OncAlert

Outcome Measures

Primary Outcome Measures

Association of RAPID results with oral cavity / oropharyngeal biopsy. [18 months]
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.
Association of RAPID results with the clinical decision process for avoiding an immediate biopsy. [18 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

23 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dr. Joel Epstein	Beverly Hills	California	United States	90211
2	Biosolutions Clinical Research Center	La Mesa	California	United States	91941
3	Loma Linda School of Dentistry	Loma Linda	California	United States	92350
4	Tower ENT, based at Cedars Sinai Medical Center	Los Angeles	California	United States	90048
5	Sacramento ENT	Roseville	California	United States	95661
6	Sacramento ENT	Sacramento	California	United States	95815
7	UConn Dental Medicine	Farmington	Connecticut	United States	06030
8	University of Miami Health Systems	Miami	Florida	United States	33136
9	ENT of South Florida Plantation	Plantation	Florida	United States	33324
10	ENT of South Florida Port St. Lucie	Port Saint Lucie	Florida	United States	34952
11	Asclepes Research	Weeki Wachee	Florida	United States	34607
12	Chicago ENT	Chicago	Illinois	United States	60657
13	Heartland Medical Research	Clive	Iowa	United States	50325
14	University of Maryland	Baltimore	Maryland	United States	21201
15	Tufts University	Boston	Massachusetts	United States	02111
16	Boston University Dental School	Boston	Massachusetts	United States	02215
17	UMKC School of Dentistry	Kansas City	Missouri	United States	64108
18	Duke Head and Neck Surgery & Communication Services	Durham	North Carolina	United States	27710
19	Eastern Carolina University School of Dental Medicine	Greenville	North Carolina	United States	27834
20	Piedmont Ear, Nose and Throat Associates	Winston-Salem	North Carolina	United States	27106
21	Specialty Physician Associates	Bethlehem	Pennsylvania	United States	18017
22	Medical University of South Carolina	Charleston	South Carolina	United States	29425
23	University of Tennessee	Memphis	Tennessee	United States	38163
24	Fort Worth ENT	Fort Worth	Texas	United States	76109
25	Berkson Medical, LLC	Mansfield	Texas	United States	76063
26	Chrysalis Clinical Research	Saint George	Utah	United States	84790