Neoplasms

All Conditions

Mouth and Tooth Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Mouth Neoplasms

Precancerous Conditions

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Oral Squamous Cell Carcinoma

Oral Cancer

Lip and Oral Cavity Cancer

OSCC case cohort will consist of patients with Oral Squamous Cell Carcinoma (all stages, locations), recruited from secondary care.

OPC case cohort will consist of patients with OroPharyngeal cancer (all stages, locations), recruited from secondary care.

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

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.

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.

OralViome Cancer Testing System

Mory Mehrtash, MSc

Momchilo Vuyisich, PhD

Gavin Hougham, PhD

Bruno Villazhinay, MPH

Cristina Julian, PhD

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.

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.

Detection of Oral and Throat Cancers Using OralViome Cancer Testing System

Detection of Oral and Throat Cancers Using Saliva Metatranscriptomic Analysis

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Detection of Oral and Throat Cancers Using OralViome Cancer Testing System	NCT05451303	Oral Squamous C... Oropharynx Squa... Premalignant Le...	OralViome Cance...	18 Years -	Viome
Detection of Oral and Throat Cancers Using OralViome Cancer Testing System	NCT05451303	Oral Squamous C... Oropharynx Squa... Premalignant Le...	OralViome Cance...	18 Years -	Viome

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