Spots Global Cancer Trial Database for Detection of Oral and Throat Cancers Using OralViome Cancer Testing System

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Trial Identification

Brief Title: Detection of Oral and Throat Cancers Using OralViome Cancer Testing System

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

Study ID: NCT05451303

Conditions

Oral Squamous Cell Carcinoma

Oropharynx Squamous Cell Carcinoma

Premalignant Lesion

Interventions

OralViome Cancer Testing System

Study Description

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.