Palatal NeoplasmsNCT03239834
Clinical Evaluation of the OncAlert RAPID in Subjects Presenting for Evaluation and/or Initial Biopsy; Impact on Decision-Making
An observational study of Palatal Neoplasms and Lip Neoplasm, run by Vigilant Biosciences, Inc. at 26 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 23 years and older
- Conditions the study is for
- Palatal Neoplasms, Lip Neoplasm, Gingival Neoplasms
- What is being tested?
- OncAlert
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 893 participants
- Where
- 26 sitesUnited States
- Study dates
- 7 Sep 2017to 20 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
University of Maryland
Baltimore, Maryland, 21201
Specialty Physician Associates
Bethlehem, Pennsylvania, 18017
Dr. Joel Epstein
Beverly Hills, California, 90211
Tufts University
Boston, Massachusetts, 02111
Boston University Dental School
Boston, Massachusetts, 02215
Medical University of South Carolina
Charleston, South Carolina, 29425
Chicago ENT
Chicago, Illinois, 60657
Heartland Medical Research
Clive, Iowa, 50325
Duke Head and Neck Surgery & Communication Services
Durham, North Carolina, 27710
UConn Dental Medicine
Farmington, Connecticut, 06030
Fort Worth ENT
Fort Worth, Texas, 76109
Eastern Carolina University School of Dental Medicine
Greenville, North Carolina, 27834
UMKC School of Dentistry
Kansas City, Missouri, 64108
Biosolutions Clinical Research Center
La Mesa, California, 91941
Loma Linda School of Dentistry
Loma Linda, California, 92350
Tower ENT, based at Cedars Sinai Medical Center
Los Angeles, California, 90048
Berkson Medical, LLC
Mansfield, Texas, 76063
University of Tennessee
Memphis, Tennessee, 38163
University of Miami Health Systems
Miami, Florida, 33136
ENT of South Florida Plantation
Plantation, Florida, 33324
ENT of South Florida Port St. Lucie
Port Saint Lucie, Florida, 34952
Sacramento ENT
Roseville, California, 95661
Sacramento ENT
Sacramento, California, 95815
Chrysalis Clinical Research
St. George, Utah, 84790
Asclepes Research
Weeki Wachee, Florida, 34607
Piedmont Ear, Nose and Throat Associates
Winston-Salem, North Carolina, 27106
About this study
Official title: Clinical Evaluation of the OncAlert RAPID; Impact on Decision-Making
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.
Read more
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.
Read the 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.
- Conditions
- Palatal Neoplasms, Lip Neoplasm, Gingival Neoplasms, Leukoplakia, Oral, Tongue Neoplasms, Oropharyngeal Neoplasms
- Being tested
- OncAlert
- Medical subject headings
- Palatal Neoplasms, Lip Neoplasms, Gingival Neoplasms, Leukoplakia, Oral, Tongue Neoplasms, Oropharyngeal Neoplasms, Oral Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OncAlertDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: OncAlert | |
| 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 Receives: 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. Receives: Device: OncAlert |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2017
- Study start7 Sep 2017
- Primary completion24 Aug 2020
- Study completion20 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palatal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 893 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vigilant Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pearl Pathways
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03239834
- Sponsor's protocol ID
- VIG-001
- Status last verified
- Aug 2021
- First submitted
- 19 Jun 2017
- Last updated
- 12 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the OncAlert RAPID; Impact on Decision-Making
- ClinicalTrials.gov ID
- NCT03239834
- Acronym / sponsor ID
- VIG-001
- Conditions
- Palatal Neoplasms, Lip Neoplasm, Gingival Neoplasms, Leukoplakia, Oral, Tongue Neoplasms, Oropharyngeal Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 893 participants (actual)
- Lead sponsor
- Vigilant Biosciences, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Pearl Pathways
- Study start
- 7 Sep 2017 (actual)
- Primary completion
- 24 Aug 2020 (actual)
- Study completion
- 20 Dec 2020 (actual)
- First posted
- 4 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OncAlert RAPID test in oral cavity biopsy patients. | – | Device: OncAlertPatients 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. | – | Device: OncAlertPatients 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. | – | Device: OncAlertPatients 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. |
Who may qualify
- Ages
- 23 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OncAlertA 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. | Device | OncAlert RAPID test in clinical decision to biopsy., OncAlert RAPID test in oral cavity biopsy patients., OncAlert RAPID test in oropharyngeal biopsy patients. |
Primary outcome
Association of RAPID results with oral cavity / oropharyngeal biopsy.
Time frame: 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.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Palatal Neoplasms and Lip Neoplasm, run by Vigilant Biosciences, Inc. at 26 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association of RAPID results with oral cavity / oropharyngeal biopsy. (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2021.