Detecting oral and throat cancers using a saliva test
Detection of Oral and Throat Cancers Using Saliva Metatranscriptomic Analysis
This study is testing a saliva test to see if it can help detect oral and throat cancers early in people, including those who are healthy and those with existing conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 475 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Viome Industry-sponsored |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05451303 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the safety and efficacy of the OralViome Cancer Testing system for early detection of oral and throat cancers through saliva metatranscriptomic analysis. A total of 475 participants will be recruited from various clinical sites, including cancer-free individuals, those with Oral Potentially Malignant Disease (OPMD), and patients diagnosed with Oral Squamous Cell Carcinoma (OSCC) or OroPharyngeal Cancer (OPC). Participants will complete health questionnaires and provide saliva samples using kits supplied by Viome, with study participation lasting up to one year for certain cohorts.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18 and older who are at high risk of developing oral or throat cancer as determined by their clinician.
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 study could lead to earlier detection of oral and throat cancers, improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using saliva-based tests for cancer detection, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Signed Informed Consent obtained * 18 years and older * At a high risk of developing oral or throat cancer based on clinician's discretion Exclusion Criteria * Pregnancy * Use of fertility enhancing medications
Where this trial is running
New York, New York
- Nymc — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Cristina Julian, PhD — Viome
- Study coordinator: Mory Mehrtash, MSc
- 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.