Validity of Viome's Oral/throat Cancer Test

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Viome
Study ID
NCT06174428
Status
Recruiting
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Conditions

  • Oral Squamous Cell Carcinoma
  • Oral and Throat Cancer
  • Oropharyngeal Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Oral/Throat cancer test — DEVICE
    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 Details

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.

Key Dates

Start date
Jan 27, 2025
Status verified
Jan 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: Oral Squamous Cell Carcinoma (OSCC)
    OSCC case cohort will consist of patients with Oral Squamous Cell Carcinoma (all stages, locations), recruited from either primary or secondary care.
  • Arm: Oropharyngeal Squamous Cell Carcinoma (OPSCC)
    OPSCC case cohort will consist of patients with Oral Squamous Cell Carcinoma (all stages, locations), recruited from either primary or secondary care.
  • Arm: Cancer-free
    Participants will be recruited following clinical adjudication with self-reported confirmation of no cancer and from primary and secondary care facilities.

Primary Outcome Measure

Sensitivity [ Time Frame: Through study completion, an average of 18 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Missouri School of Dentistry & Oral HealthSt LouisMissouri63104
Adepitan Owosho
[email protected]
314-833-2729
UTHSCMemphisTennessee38163
Yanhui Zhang, Ph.D.
[email protected]
901.448.3751

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