Trials / Recruiting
RecruitingNCT05451303
Detection of Oral and Throat Cancers Using OralViome Cancer Testing System
Detection of Oral and Throat Cancers Using Saliva Metatranscriptomic Analysis
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 475 (estimated)
- Sponsor
- Viome · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
This is an observational study evaluating the design, safety and efficacy of OralViome Cancer Testing system in the early detection of Oral and Throat Cancers using saliva metatranscriptomic. A total of 475 participants will be recruited, including 4 different cohorts: 1) cancer free patients, 2) patients with Oral Potentially Malignant Disease (OPMD), 3) patients with Oral Squamous Cell Carcinoma (OSCC), and 4) patients with OroPharyngeal Cancer (OPC). OSCC and OPC participants will be recruited from secondary care facilities, OPMD and cancer free participants will be recruited from primary care facilities. Participants will complete health questionnaires and collect saliva samples using at home/ in clinic kits provided by Viome. The duration of study participation will be 1 clinic visit for cancer free participants, and up to 1 year for those with OSCC/OPC/OPMD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | OralViome Cancer Testing System | The 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. |
Timeline
- Start date
- 2022-05-27
- Primary completion
- 2026-12-01
- Completion
- 2026-12-01
- First posted
- 2022-07-11
- Last updated
- 2025-01-29
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05451303. Inclusion in this directory is not an endorsement.