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Detection of Oral and Throat Cancers Using OralViome Cancer Testing System

Oral Squamous Cell Carcinoma Clinical Trial

Official title:
Detection of Oral and Throat Cancers Using Saliva Metatranscriptomic Analysis

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05451303
Study type Observational
Source Viome
Contact Mory Mehrtash, MSc
Phone 425-300-6933
Email studies@viome.com
Status Recruiting
Phase
Start date May 27, 2022
Completion date December 2025
View Details
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