Recruiting

OralViomeDetection of Oral and Throat Cancers Using OralViome Cancer Testing System

Sponsor:

Viome

Code:

NCT05451303

Conditions

Oral Squamous Cell Carcinoma

Oropharynx Squamous Cell Carcinoma

Premalignant Lesion

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

OralViome Cancer Testing System

Study Details

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.

Conditions

Oral Squamous Cell Carcinoma

Oropharynx Squamous Cell Carcinoma

Premalignant Lesion

Study ID

NCT05451303

Start date

May 27, 2022

Status verified date

Jan, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

475 participants

Anticipated

Interventions and Outcome Measures

Arms

Oral Squamous Cell Carcinoma (OSCC)

OSCC case cohort will consist of patients with Oral Squamous Cell Carcinoma (all stages, locations), recruited from secondary care.

OroPharyngeal Cancer (OPC)

OPC case cohort will consist of patients with OroPharyngeal cancer (all stages, locations), recruited from secondary care.

Oral Potentially Malignant Disease (OPMD)

OPMD cohort will consist of patients with both potential malignancies or benign conditions including, but not limited to:

Dysplasia
Hyperplasia
Leukoplakia
Erythroplasia
Lichenoid lesions
Actinic Keratosis
Lichenoid reaction
Aphthous ulcer/ Canker Sores
Gingival enlargement (side effect)
Lichen planus
Keratosis
Inflammatory reaction
Cheek bites

Cancer-free

Cancer free control cohort will be matched with cases. Participants will be recruited following clinical adjudication with self-reported confirmation of no cancer and from primary care facilities.

Interventions

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.

Primary outcome measure

The primary endpoint will be the detection or not of OSCC or OPC [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Mory Mehrtash, MSc

425-300-6933 studies@viome.com

Momchilo Vuyisich, PhD

425-300-6933 studies@viome.com

Locations

NYMC

Recruiting

New York, New York, United States, 10595

Contacts

Mohanapriya Rajamoorthy

(914) 594-4575

More Information

Sponsor

Viome

Last update posted

Jan 29, 2025

Last verified

Jan, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Viome on 2025-01-29.