Validity of Viome's Oral/throat Cancer Test Among Patients with a Suspicion of Cancer
Data Collection
Collected from today forward - ProspectiveSquamous Cell Carcinoma of Head and Neck+8
+ Carcinoma
+ Carcinoma, Squamous Cell
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: January 27, 2025
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.1000 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Missouri School of Dentistry & Oral Health
St Louis, United StatesOpen Missouri School of Dentistry & Oral Health in Google MapsUTHSC
Memphis, United States