Validity of Viome's Oral/throat Cancer Test

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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

Primary outcome measure(s)

• Sensitivity — Through study completion, an average of 18 months
  Oral/Throat cancer test's ability to designate an individual with disease as positive
• Specificity — Through study completion, an average of 18 months
  Oral/Throat cancer test's ability to designate an individual who does not have a disease as negative
• Positive Post Test Probability (PPV) — Through study completion, an average of 18 months
  The probability of having the target condition if the test falls out positive
• Negative Post Test Probability (NPV) — Through study completion, an average of 18 months
  The probability of having the target condition if the test falls out negative

Trial sites (2)

More Viome trials in the USA

Other trials for the same condition