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Detection of Oral and Throat Cancers Using OralViome Cancer Testing System

NCT05451303 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 475

Last updated 2025-01-29

No results posted yet for this study

Summary

To evaluate the design, safety and efficacy of OralViome Cancer Testing system in the early detection of Oral and Throat Cancers using saliva metatranscriptomic analysis. This study will recruit only at existing clinical sites and will NOT use any additional clinical sites.

Conditions

  • Oral Squamous Cell Carcinoma
  • Oropharynx Squamous Cell Carcinoma
  • Premalignant Lesion

Interventions

DEVICE

OralViome Cancer Testing System

The OralViome Cancer Testing System is intended for the screening of Oral Squamous Cell Carcinoma (OSCC) and Oropharyngeal cancer (OPC). The system consists of the OralViome Saliva Collection and Transport Kit, the Viome laboratory process for metatranscriptomics, and the Viome analytical software that detects an RNA expression signature within a saliva sample.

Sponsors & Collaborators

  • New York Medical College

    collaborator OTHER

  • Viome

    lead INDUSTRY

Principal Investigators

  • Cristina Julian, PhD · Viome

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-27
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

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 NCT05451303 on ClinicalTrials.gov