Detection of Oral and Throat Cancers Using OralViome Cancer Testing System
Detection of Oral and Throat Cancers Using Saliva Metatranscriptomic Analysis
Viome
475 participants
May 27, 2022
OBSERVATIONAL
Conditions
Summary
To evaluate the design, safety and efficacy of OralViome Cancer Testing system in the early detection of Oral and Throat Cancers using saliva metatranscriptomic analysis. This study will recruit only at existing clinical sites and will NOT use any additional clinical sites.
Eligibility
Inclusion Criteria3
- Signed Informed Consent obtained
- years and older
- At a high risk of developing oral or throat cancer based on clinician's discretion
Exclusion Criteria2
- Pregnancy
- Use of fertility enhancing medications
Interventions
The OralViome Cancer Testing System is intended for the screening of Oral Squamous Cell Carcinoma (OSCC) and Oropharyngeal cancer (OPC). The system consists of the OralViome Saliva Collection and Transport Kit, the Viome laboratory process for metatranscriptomics, and the Viome analytical software that detects an RNA expression signature within a saliva sample.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05451303