NCT06174428

Validity of Viome's Oral/throat Cancer Test

Validity of Viome's Oral/throat Cancer Test Among Patients with a Suspicion of Cancer

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Viome · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, multi-center study. Subjects with OSCC or OPSCC will be enrolled from four primary and secondary care centers in the U.S. Study samples will be collected by the clinicians at the study sites using Viome saliva sample collection kits. Patients will continue with their current health plan and confirm diagnosis following the standard of care of surgical biopsy with histology if needed. If a biopsy is performed, the result of the biopsy will be compared with the result of the Viome kit. If no biopsy is performed, the Viome test result will be compared with the physician's assessment based on clinical judgment. Patients with a positive result from histology will not receive the results of the Viome kit, and it will not play any part in the clinical management of the patients.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-01-27
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2023-12-18
• Last updated: 2025-01-29

Locations

2 sites across 1 country: United States