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Viome's Oral/Throat Cancer Test Study

This study is looking at how well Viome's Oral/Throat cancer test works. This test checks saliva samples for signs of oral squamous cell carcinoma (OSCC) or oropharyngeal squamous cell carcinoma (OPSCC), which are types of mouth and throat cancer. You might be able to join if you are an adult (18 or older) and your doctor suspects you might have one of these cancers. The study will measure how accurately the test identifies cancer (sensitivity), how accurately it identifies those without cancer (specificity), and the chance of actually having cancer if the test is positive (positive post test probability). The study is currently recruiting, but the exact status is unclear.

Study design
This is an observational study planning to enroll 1000 participants, including at least 107 with a diagnosis of OSCC or OPSCC.
What's involved
You would provide a saliva sample using a Viome collection kit. You will continue with your usual medical care, including any biopsies, as determined by your doctor.
Compensation
Not stated in the trial record.
Follow-up
The study will measure outcomes over an average of 18 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06174428

Validity of Viome's Oral/throat Cancer Test

Recruiting
Not specifiedAges 18+Observational
Viome
~1,000 participants
Updated 2025-01-29 on ClinicalTrials.gov
What's tested:Oral/Throat cancer test

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sensitivity
Measured over Through study completion, an average of 18 months
+3 more outcomes measured

Conditions

Oral and Throat Cancer
Oropharyngeal Squamous Cell Carcinoma
Oral Squamous Cell Carcinoma

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Lip and Oral Cavity CarcinomaOral Cavity Squamous Cell CarcinomaOropharyngeal Squamous Cell CarcinomaThroat Carcinoma

Where it's being run

2 sites across 2 states
Missouri1
Tennessee1

Study leadership

  • Cristina Julian · PRINCIPAL_INVESTIGATOR · Viome

Who to contact

Mory Mehrtash
[email protected]
425-300-6933
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Pregnancy
Use of fertility enhancing medications

What this trial measures

  • SensitivityThrough study completion, an average of 18 months

    Oral/Throat cancer test's ability to designate an individual with disease as positive

  • SpecificityThrough study completion, an average of 18 months

    Oral/Throat cancer test's ability to designate an individual who does not have a disease as negative

  • Positive Post Test Probability (PPV)Through study completion, an average of 18 months

    The probability of having the target condition if the test falls out positive

  • Negative Post Test Probability (NPV)Through study completion, an average of 18 months

    The probability of having the target condition if the test falls out negative