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Recruiting NCT05451303

Detection of Oral and Throat Cancers Using OralViome Cancer Testing System

— Observational Oral Squamous Cell Carcinoma Oropharynx Squamous Cell Carcinoma Premalignant Lesion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: OralViome Cancer Testing System.
Who it may be relevant to
Registry conditions: Oral Squamous Cell Carcinoma, Oropharynx Squamous Cell Carcinoma, Premalignant Lesion. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Detection of Oral and Throat Cancers Using Saliva Metatranscriptomic Analysis

Overview

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

  • 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.

Primary outcome measures

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

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

United States · 1 center
  • NYMC — New York

Identifiers

NCT: NCT05451303 · V300

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗