OralViome Cancer Testing System for Oral and Throat Cancers

This study is looking at a new way to detect oral and throat cancers early using a saliva test called the OralViome Cancer Testing System. This system uses a saliva collection kit, a lab process to analyze your saliva, and special software. We want to see how well this system works to find oral squamous cell carcinoma (OSCC) and oropharyngeal cancer (OPC). We are looking for 475 people, including those who are cancer-free, those with precancerous conditions (Oral Potentially Malignant Disease), and those already diagnosed with OSCC or OPC. The main goal is to see if the system can detect these cancers within one year. We are currently recruiting participants.

Study design
This is an observational study involving 475 participants across four groups: cancer-free, precancerous, oral cancer, and throat cancer.
What's involved
You will complete health questionnaires and provide saliva samples using kits. Cancer-free participants will have one clinic visit, while others may participate for up to one year.
Compensation
Not stated in the trial record.
Follow-up
The study will track whether cancer is detected for up to one year.

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NCT05451303

Detection of Oral and Throat Cancers Using OralViome Cancer Testing System

Recruiting
Not specifiedAges 18+Observational
Viome
~475 participants
Updated 2025-01-29 on ClinicalTrials.gov
What's tested:OralViome Cancer Testing System

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The primary endpoint will be the detection or not of OSCC or OPC
Measured over 1 year
Oral Squamous Cell Carcinoma
Oropharynx Squamous Cell Carcinoma
Premalignant Lesion
1 sites across 1 states
New York1
  • Cristina Julian, PhD · PRINCIPAL_INVESTIGATOR · Viome

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Eligibility criteria

Inclusion

Signed Informed Consent obtained
18 years and older
At a high risk of developing oral or throat cancer based on clinician's discretion

Exclusion

Pregnancy
Use of fertility enhancing medications
  • The primary endpoint will be the detection or not of OSCC or OPC1 year

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