Detection of Oral and Throat Cancers Using OralViome Cancer Testing System

Condition(s) studied

Investigational drug(s) / intervention(s)

OralViome Cancer Testing System: 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.

Study 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

Primary outcome measure(s)

• The primary endpoint will be the detection or not of OSCC or OPC — 1 year
  The test results will be compared against the definitive diagnosis by the physician.

Trial sites (1)

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