Detection of Oral and Throat Cancers Using OralViome Cancer Testing System

Part of paid clinical trials in New York, New York.

Sponsor
Viome
Study ID
NCT05451303
Status
Recruiting
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Conditions

  • Oral Squamous Cell Carcinoma
  • Oropharynx Squamous Cell Carcinoma
  • Premalignant Lesion

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
May 27, 2022
Status verified
Jan 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
475 participants (estimated)

Arms

  • Arm: Oral Squamous Cell Carcinoma (OSCC)
    OSCC case cohort will consist of patients with Oral Squamous Cell Carcinoma (all stages, locations), recruited from secondary care.
  • Arm: OroPharyngeal Cancer (OPC)
    OPC case cohort will consist of patients with OroPharyngeal cancer (all stages, locations), recruited from secondary care.
  • Arm: 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
  • Arm: 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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYMCNew YorkNew York10595
Mohanapriya Rajamoorthy
(914) 594-4575

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By research site
NYMC· New York, NY

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