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NCT Number: NCT05451303

Detection of Oral and Throat Cancers Using OralViome Cancer Testing System

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.

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Key information

Conditions

Oral Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Oropharynx Squamous Cell Carcinoma Premalignant Lesion Squamous Cell Carcinoma of Head and Neck Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NYMC

New York, 10595, United States

Location status: Recruiting

Location contact

Mohanapriya Rajamoorthy

CONTACT

(914) 594-4575

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OralViome Cancer Testing System

Device

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 outcomes

  1. The primary endpoint will be the detection or not of OSCC or OPC

    Time frame: 1 year

    The test results will be compared against the definitive diagnosis by the physician.

Study contacts

Contact information is provided by the study sponsor or research team.

Momchilo Vuyisich, PhD

CONTACT

[email protected]

425-300-6933

Mory Mehrtash, MSc

CONTACT

[email protected]

425-300-6933

Sponsors and collaborators

Lead sponsor

Viome

Industry

Collaborators

  • New York Medical College

Registry information

Official study title

Detection of Oral and Throat Cancers Using Saliva Metatranscriptomic Analysis

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jul 11, 2022
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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