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Validity of Viome's Oral/throat Cancer Test
Sponsor: Viome
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.
Official title: Validity of Viome's Oral/throat Cancer Test Among Patients with a Suspicion of Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
1000
Start Date
2025-01-27
Completion Date
2026-12
Last Updated
2025-01-29
Healthy Volunteers
No
Interventions
Oral/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