Status:
COMPLETED
Clinical Evaluation of the OncAlert RAPID in Subjects Presenting for Evaluation and/or Initial Biopsy; Impact on Decision-Making
Lead Sponsor:
Vigilant Biosciences, Inc.
Collaborating Sponsors:
Pearl Pathways
Conditions:
Palatal Neoplasms
Lip Neoplasm
Eligibility:
All Genders
23+ years
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, ...
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 ora...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 7 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 20 2020
Estimated Enrollment :
893 Patients enrolled
Trial Details
Trial ID
NCT03239834
Start Date
September 7 2017
End Date
December 20 2020
Last Update
August 12 2021
Active Locations (26)
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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