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

Plain Language Summary

Simplified for easier understanding

This study tests a new saliva- and swab-based test (OralViome Cancer Testing System) that analyzes bacteria and genetic material in the mouth to detect oral and throat cancers. The goal is to see if this non-invasive test can catch cancers early or accurately identify patients who need further workup. **You may be eligible if...** - You are an adult with a suspicious lesion in your mouth or throat that is being evaluated for possible cancer - OR you are a healthy adult without known oral/throat cancer (serving as a comparison group) - You are able to provide a saliva or swab sample **You may NOT be eligible if...** - You are unable to provide a saliva or oral swab sample - You have conditions that would make the sample unreliable - You are under 18 years old Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05451303


Related Trials