Validity of Viome's Oral/throat Cancer Test

Viome

Status: Enrolling

Conditions: Oral and Throat Cancer; Oral Squamous Cell Carcinoma; Oropharyngeal Squamous Cell Carcinoma

Treatments: Device: Oral/Throat cancer test

Study type: Observational

Funder types: Industry

Identifiers

NCT06174428

V303

Details and patient eligibility

About

A total of at least 1,000 participants with suspicion of cancer including at least 107 subjects who will be diagnosed with OSCC or OPSCC will be enrolled from either primary or secondary care centers in the U.S. Clinicians will use Viome collection kits to collect saliva samples from eligible patients.

Full description

This is a prospective, multi-center study. Subjects with OSCC or OPSCC will be enrolled from four primary and secondary care centers in the U.S. Study samples will be collected by the clinicians at the study sites using Viome saliva sample collection kits. Patients will continue with their current health plan and confirm diagnosis following the standard of care of surgical biopsy with histology if needed. If a biopsy is performed, the result of the biopsy will be compared with the result of the Viome kit. If no biopsy is performed, the Viome test result will be compared with the physician's assessment based on clinical judgment. Patients with a positive result from histology will not receive the results of the Viome kit, and it will not play any part in the clinical management of the patients.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed and dated informed consent prior to any study-specific procedures are performed
• Willing and able to follow the study instructions, as described in the recruitment letter
• Adults (18 years old or older)
• Suspicion of OSCC or OPSCC on clinical presentation by a clinician

Exclusion criteria

• Pregnancy
• Use of fertility enhancing medications

Trial design

1,000 participants in 3 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 either primary or secondary care.

Treatment:

Device: Oral/Throat cancer test

Oropharyngeal Squamous Cell Carcinoma (OPSCC)

Description:

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

Treatment:

Device: Oral/Throat cancer test

Cancer-free

Description:

Participants will be recruited following clinical adjudication with self-reported confirmation of no cancer and from primary and secondary care facilities.

Treatment:

Device: Oral/Throat cancer test