Clinical Evaluation of the OncAlert RAPID in Subjects Presenting for Evaluation and/or Initial Biopsy; Impact on Decision-Making
1 other identifier
observational
893
1 country
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2017
Typical duration for all trials
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2017
CompletedFirst Posted
Study publicly available on registry
August 4, 2017
CompletedStudy Start
First participant enrolled
September 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 24, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2020
CompletedAugust 12, 2021
August 1, 2021
3 years
June 19, 2017
August 11, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Association of RAPID results with oral cavity / oropharyngeal biopsy.
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.
18 months
Association of RAPID results with the clinical decision process for avoiding an immediate biopsy.
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.
18 months
Study Arms (3)
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.
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
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.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vigilant Biosciences, Inc.lead
- Pearl Pathwayscollaborator
Study Sites (26)
Dr. Joel Epstein
Beverly Hills, California, 90211, United States
Biosolutions Clinical Research Center
La Mesa, California, 91941, United States
Loma Linda School of Dentistry
Loma Linda, California, 92350, United States
Tower ENT, based at Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
Sacramento ENT
Roseville, California, 95661, United States
Sacramento ENT
Sacramento, California, 95815, United States
UConn Dental Medicine
Farmington, Connecticut, 06030, United States
University of Miami Health Systems
Miami, Florida, 33136, United States
ENT of South Florida Plantation
Plantation, Florida, 33324, United States
ENT of South Florida Port St. Lucie
Port Saint Lucie, Florida, 34952, United States
Asclepes Research
Weeki Wachee, Florida, 34607, United States
Chicago ENT
Chicago, Illinois, 60657, United States
Heartland Medical Research
Clive, Iowa, 50325, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Tufts University
Boston, Massachusetts, 02111, United States
Boston University Dental School
Boston, Massachusetts, 02215, United States
UMKC School of Dentistry
Kansas City, Missouri, 64108, United States
Duke Head and Neck Surgery & Communication Services
Durham, North Carolina, 27710, United States
Eastern Carolina University School of Dental Medicine
Greenville, North Carolina, 27834, United States
Piedmont Ear, Nose and Throat Associates
Winston-Salem, North Carolina, 27106, United States
Specialty Physician Associates
Bethlehem, Pennsylvania, 18017, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
University of Tennessee
Memphis, Tennessee, 38163, United States
Fort Worth ENT
Fort Worth, Texas, 76109, United States
Berkson Medical, LLC
Mansfield, Texas, 76063, United States
Chrysalis Clinical Research
St. George, Utah, 84790, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2017
First Posted
August 4, 2017
Study Start
September 7, 2017
Primary Completion
August 24, 2020
Study Completion
December 20, 2020
Last Updated
August 12, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share