Evaluating the OralViome Cancer Testing System for Early Detection of Oral and Throat Cancers Using Saliva Analysis

What this Trial Is About

Researchers are evaluating the OralViome Cancer Testing System to detect Oral and Throat Cancers early using saliva metatranscriptomic analysis. This observational study aims to assess the design, safety, and effectiveness of this system in identifying cancers such as Oral Squamous Cell Carcinoma OSCC and Oropharyngeal Cancer OPC. Participants include cancer-free individuals, those with potentially malignant oral diseases OPMD, and patients diagnosed with OSCC or OPC, recruited from clinical care facilities. The study involves collecting saliva samples through kits provided by Viome, which can be used at home or in clinics. Four groups will be studied cancer-free controls, patients with OPMD, and those with OSCC or OPC. Cancer-free and OPMD participants will have one clinic visit, while OSCC and OPC participants may be followed for up to one year. The OralViome system includes a saliva collection kit, a laboratory process analyzing RNA expression, and software that detects cancer-related signatures. Participants will complete health questionnaires and provide saliva samples during their involvement. The primary outcome is to determine if the system detects OSCC or OPC within one year. The study monitors participant health status without additional treatments, with a focus on safety and data collection. Total participation duration varies based on the group, with some followed for up to a year and others for a single visit.

Detection of Oral and Throat Cancers Using OralViome Cancer Testing System