RecruitingNCT05451303

Detection of Oral and Throat Cancers Using OralViome Cancer Testing System

Detection of Oral and Throat Cancers Using Saliva Metatranscriptomic Analysis


Sponsor

Viome

Enrollment

475 participants

Start Date

May 27, 2022

Study Type

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

Min Age: 18 Years

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

DEVICEOralViome 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.


Locations(1)

NYMC

New York, New York, United States

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NCT05451303


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