Detection of Oral and Throat Cancers Using OralViome Cancer Testing System
- Conditions
- Oropharynx Squamous Cell CarcinomaOral Squamous Cell CarcinomaPremalignant Lesion
- Registration Number
- NCT05451303
- Lead Sponsor
- Viome
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 475
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint will be the detection or not of OSCC or OPC 1 year The test results will be compared against the definitive diagnosis by the physician.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
NYMC
🇺🇸New York, New York, United States
NYMC🇺🇸New York, New York, United StatesMohanapriya RajamoorthyContact(914) 594-4575