Detection of Oral and Throat Cancers Using OralViome Cancer Testing System

Detection of Oral and Throat Cancers Using Saliva Metatranscriptomic Analysis

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05451303

Enrollment

475

Registered

2022-07-11

Start date

2022-05-27

Completion date

2026-12-31

Last updated

2025-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Squamous Cell Carcinoma, Oropharynx Squamous Cell Carcinoma, Premalignant Lesion

Keywords

Viome, oral cancer, detection, OSCC, OPMD-B, OPMD-PM, OPMD, OPV, Tobacco, HPV

Brief 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.

Detailed description

This is an observational study evaluating the design, safety and efficacy of OralViome Cancer Testing system in the early detection of Oral and Throat Cancers using saliva metatranscriptomic. A total of 475 participants will be recruited, including 4 different cohorts: 1) cancer free patients, 2) patients with Oral Potentially Malignant Disease (OPMD), 3) patients with Oral Squamous Cell Carcinoma (OSCC), and 4) patients with OroPharyngeal Cancer (OPC). OSCC and OPC participants will be recruited from secondary care facilities, OPMD and cancer free participants will be recruited from primary care facilities. Participants will complete health questionnaires and collect saliva samples using at home/ in clinic kits provided by Viome. The duration of study participation will be 1 clinic visit for cancer free participants, and up to 1 year for those with OSCC/OPC/OPMD.

Interventions

DEVICEOralViome 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.

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Signed Informed Consent obtained * 18 years and older * At a high risk of developing oral or throat cancer based on clinician's discretion

Exclusion criteria

* Pregnancy * Use of fertility enhancing medications

Design outcomes

Primary

Measure	Time frame	Description
The primary endpoint will be the detection or not of OSCC or OPC	1 year	The test results will be compared against the definitive diagnosis by the physician.

Countries

United States

Contacts

Primary ContactMory Mehrtash, MSc

studies@viome.com425-300-6933

Backup ContactMomchilo Vuyisich, PhD