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Validity of Viome's Oral/throat Cancer Test

NCT06174428 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2025-01-29

No results posted yet for this 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.

Conditions

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

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Viome

    lead INDUSTRY

Principal Investigators

  • Cristina Julian · Viome

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-27
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06174428 on ClinicalTrials.gov