Validity of Viome's Oral/throat Cancer Test
Validity of Viome's Oral/throat Cancer Test Among Patients with a Suspicion of Cancer
Viome
1,000 participants
Jan 27, 2025
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
Inclusion Criteria4
- Signed and dated informed consent prior to any study-specific procedures are performed
- Willing and able to follow the study instructions, as described in the recruitment letter
- Adults (18 years old or older)
- Suspicion of OSCC or OPSCC on clinical presentation by a clinician
Exclusion Criteria2
- Pregnancy
- Use of fertility enhancing medications
Interventions
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06174428