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Detection of Oral and Throat Cancers Using OralViome Cancer Testing System

Detection of Oral and Throat Cancers Using OralViome Cancer Testing System

Recruiting
18 years and older
All
Phase N/A
  • Technical (Original)
  • Simplified (AI rewritten)

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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.

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.

Eligibility

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 details
    Oral Squamous Cell Carcinoma
    Oropharynx Squamous Cell Carcinoma
    Premalignant Lesion

NCT05451303

Viome

13 May 2026

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