Testing a new saliva test for oral and throat cancer
Validity of Viome's Oral/throat Cancer Test Among Patients with a Suspicion of Cancer
This study is testing a new saliva test to see if it can help find oral and throat cancers in people who might have them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Viome Industry-sponsored |
| Locations | 2 sites (St Louis, Missouri and 1 other locations) |
| Trial ID | NCT06174428 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the validity of Viome's saliva test for detecting oral and throat cancers, specifically oropharyngeal and oral squamous cell carcinoma. A minimum of 1,000 participants suspected of having these cancers will be enrolled from multiple care centers across the U.S. Clinicians will collect saliva samples using Viome's collection kits, and results will be compared against standard diagnostic methods such as surgical biopsy and clinical assessments. Participants will continue their usual health care while the study assesses the effectiveness of the saliva test.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have a clinical suspicion of oral or throat cancer.
Not a fit: Patients who are pregnant or using fertility-enhancing medications will not benefit from this study.
Why it matters
Potential benefit: If successful, this test could provide a non-invasive method for early detection of oral and throat cancers.
How similar studies have performed: While there have been studies on saliva tests for cancer detection, the specific approach used in this study is novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
St Louis, Missouri and 1 other locations
- Missouri School of Dentistry & Oral Health — St Louis, Missouri, United States (Recruiting)
- Uthsc — Memphis, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Cristina Julian — Viome
- Study coordinator: Mory Mehrtash
- Email: studies@viome.com
- Phone: 425-300-6933
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.