RecruitingNCT06174428

Validity of Viome's Oral/throat Cancer Test

Validity of Viome's Oral/throat Cancer Test Among Patients with a Suspicion of Cancer


Sponsor

Viome

Enrollment

1,000 participants

Start Date

Jan 27, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

A total of at least 1,000 participants with suspicion of cancer including at least 107 subjects who will be diagnosed with OSCC or OPSCC will be enrolled from either primary or secondary care centers in the U.S. Clinicians will use Viome collection kits to collect saliva samples from eligible patients.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is checking whether Viome's at-home test — which analyzes RNA from saliva and throat swabs — is accurate at detecting oral and throat cancer or pre-cancerous changes, compared to clinical gold-standard diagnostic methods. **You may be eligible if...** - You are an adult who can provide oral/throat samples for testing - You are scheduled for or have recently had clinical evaluation of your oral cavity or throat **You may NOT be eligible if...** - You are unable to provide a saliva or throat swab sample - You have a condition that would prevent meaningful test results 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.

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Interventions

DEVICEOral/Throat cancer test

The Oral/Throat cancer test is intended for the qualitative detection of molecular features (human genes, microbial species and functions) associated with Oral Squamous Cell Carcinoma (OSCC) or OroPharyngeal Squamous Cell Carcinoma (OPSCC) in saliva samples from adults with a suspicion of cancer. A positive result from CDOT may indicate the presence of OSCC or OPSCC. The device is intended as a diagnostic aid for clinicians when assessing patients with suspected OSCC or OPSCC who may benefit from follow-up diagnosis and treatment. The device is not intended for a definitive diagnosis.


Locations(2)

Missouri School of Dentistry & Oral Health

St Louis, Missouri, United States

UTHSC

Memphis, Tennessee, United States

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NCT06174428


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