Clinical trial NCT03239834: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Palatal Neoplasms
Lip Neoplasm
Gingival Neoplasms
Leukoplakia, Oral
Tongue Neoplasms
Oropharyngeal Neoplasms
Oral Ulcer
Lead sponsor: Vigilant Biosciences, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Pearl Pathways
First posted: 2017-08-04
Enrollment: 893
Sex: ALL
Minimum age (years): 23
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: For the current study cohort,we anticipate working with 20 or more institutions to obtain oral rinse saliva samples from up to 1000patients (most patients scheduled for biopsyof the oral cavity or oropharynx and not more than 200 non-biopsy patients) from different geographic regions.

The study population will be representative of adults at least 23 years of age who have been diagnosed as described in inclusion criteria.

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.

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

Primary outcomes:
measure: Association of RAPID results with oral cavity / oropharyngeal biopsy.
timeFrame: 18 months
measure: Association of RAPID results with the clinical decision process for avoiding an immediate biopsy.
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Dr. Joel Epstein
state: California
city: La Mesa
country: United States
facility: Biosolutions Clinical Research Center
state: California
city: Loma Linda
country: United States
facility: Loma Linda School of Dentistry
state: California
city: Los Angeles
country: United States
facility: Tower ENT, based at Cedars Sinai Medical Center
state: California
city: Roseville
country: United States
facility: Sacramento ENT
state: California
city: Sacramento
country: United States
facility: Sacramento ENT
state: California
city: Farmington
country: United States
facility: UConn Dental Medicine
state: Connecticut
city: Miami
country: United States
facility: University of Miami Health Systems
state: Florida
city: Plantation
country: United States
facility: ENT of South Florida Plantation
state: Florida
city: Port Saint Lucie
country: United States
facility: ENT of South Florida Port St. Lucie
state: Florida
city: Weeki Wachee
country: United States
facility: Asclepes Research
state: Florida
city: Chicago
country: United States
facility: Chicago ENT
state: Illinois
city: Clive
country: United States
facility: Heartland Medical Research
state: Iowa
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: Tufts University
state: Massachusetts
city: Boston
country: United States
facility: Boston University Dental School
state: Massachusetts
city: Kansas City
country: United States
facility: UMKC School of Dentistry
state: Missouri
city: Durham
country: United States
facility: Duke Head and Neck Surgery & Communication Services
state: North Carolina
city: Greenville
country: United States
facility: Eastern Carolina University School of Dental Medicine
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Ear, Nose and Throat Associates
state: North Carolina
city: Bethlehem
country: United States
facility: Specialty Physician Associates
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: University of Tennessee
state: Tennessee
city: Fort Worth
country: United States
facility: Fort Worth ENT
state: Texas
city: Mansfield
country: United States
facility: Berkson Medical, LLC
state: Texas
city: Saint George
country: United States
facility: Chrysalis Clinical Research
state: Utah
Study officials:
References: