An observational study in Palatal Neoplasms, Lip Neoplasm and Gingival Neoplasms, sponsored by Vigilant Biosciences, Inc.. Completed at 26 sites in United States. Open to participants aged 23 Years and older. Per ClinicalTrials.gov, last updated 2021-08-12.
Sponsored by Vigilant Biosciences, Inc. · Observational
Among 11 studies in Lip Neoplasms with a site in United States — 4 open to participants now, 5 under way, none of them phase 3. Lip Neoplasms · United States.
Among the 11 studies in Lip Neoplasms with a site in United States, this one is one of 3 that started in 2017, is one of 6 observational ones, and was the 7th registered.
20 studies on the registry are indexed under Lip Neoplasms; 7 are open to participants now.
Browse Lip Neoplasms studies →4 of the 11 studies in Lip Neoplasms with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 6 Lip Neoplasms studies recruiting now, 4 (67%) set no upper age limit and 0 (0%) stop at 75 or younger; 0 take children under 18; 1 take healthy volunteers.
This study: 23 Years and older · all sexes · no healthy volunteers.
The full table on the hub →11 studies; the count open now beside each. This study's row is marked.
First in 1998; this study’s year is marked. 3 started in 2017.
Median enrollment 47 across the 4 interventional studies, 158 across the 6 observational. Of the 6 that completed or were terminated, 1 (17%) have results posted.
3 of 11 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Vigilant Biosciences, Inc. as lead sponsor.
Vigilant Biosciences, Inc. has 1 study filed under Lip Neoplasms — fewer than ten, so there is no comparison to draw.
2 of the studies in Lip Neoplasms with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05837221University of Colorado, DenverMicrobiome in Head and Neck Squamous Cell Carcinoma | 2026-11 |
| NCT00568490Stanford UniversityIdentification of Secreted Markers for Tumor Hypoxia in Patients With Head and Neck or Lung Cancers | 2027-06-30 |
Among the 11 studies in Lip Neoplasms with a site in United States, from their registry updates:
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 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.
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:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
Time frame: 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.
Time frame: 18 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2017 to primary completion in Aug 2020, 35 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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