Detection of Oral and Throat Cancers Using OralViome Cancer Testing System
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorViome
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Signed Informed Consent obtained
18 years and older
At a high risk of developing oral or throat cancer based on clinician's discretion
Disqualifiers
Pregnancy
Use of fertility enhancing medications
Trial population
Participants will be recruited into one of four cohorts, OSCC, OPC, OPMD, or cancer free cohorts.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
OralViome Cancer Testing System
DeviceThe 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.
Treatment groups
475 Participants
are divided into 4 treatment groupsGroup A: Oral Squamous Cell Carcinoma (OSCC)1 intervention
Group B: OroPharyngeal Cancer (OPC)1 intervention
Group C: Oral Potentially Malignant Disease (OPMD)1 intervention
Group D: Cancer-free1 intervention
Trial outcomes
Primary outcomes
1
The primary endpoint will be the detection or not of OSCC or OPC
The test results will be compared against the definitive diagnosis by the physician.
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Viome
Lead sponsor
New York Medical College
Collaborator
Source ClinicalTrials.gov