Detection of Oral and Throat Cancers Using OralViome Cancer Testing System

Viome

Status: Enrolling

Conditions: Oropharynx Squamous Cell Carcinoma; Oral Squamous Cell Carcinoma; Premalignant Lesion

Treatments: Device: OralViome Cancer Testing System

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05451303

V300

Details and patient eligibility

About

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.

Full 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.

Enrollment: 475 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

475 participants in 4 patient groups

Oral Squamous Cell Carcinoma (OSCC)

Description:

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

Treatment:

Device: OralViome Cancer Testing System

OroPharyngeal Cancer (OPC)

Description:

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

Treatment:

Device: OralViome Cancer Testing System

Oral Potentially Malignant Disease (OPMD)

Description:

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

Treatment:

Device: OralViome Cancer Testing System

Cancer-free

Description:

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.

Treatment:

Device: OralViome Cancer Testing System