Detection of Oral and Throat Cancers Using OralViome Cancer Testing System

Recruiting

• Conditions: Oropharynx Squamous Cell Carcinoma; Oral Squamous Cell Carcinoma; Premalignant Lesion
• Interventions: Device: OralViome Cancer Testing System

• Registration Number: NCT05451303
• Lead Sponsor: Viome

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.

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.

Study Timeline

• Study Start: 2022-05-27
• Study First Submitted: 2022-07-05
• Study First Submitted QC: 2022-07-05
• Study First Posted: 2022-07-11
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-29
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 475

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Oral Squamous Cell Carcinoma (OSCC)	OralViome Cancer Testing System	OSCC case cohort will consist of patients with Oral Squamous Cell Carcinoma (all stages, locations), recruited from secondary care.
OroPharyngeal Cancer (OPC)	OralViome Cancer Testing System	OPC case cohort will consist of patients with OroPharyngeal cancer (all stages, locations), recruited from secondary care.
Cancer-free	OralViome Cancer Testing System	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.
Oral Potentially Malignant Disease (OPMD)	OralViome Cancer Testing System	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

Primary Outcome Measures

Name	Time	Method
The primary endpoint will be the detection or not of OSCC or OPC	1 year	The test results will be compared against the definitive diagnosis by the physician.

Trial Locations

Locations (1)

NYMC; 🇺🇸 New York, New York, United States