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NCT05451303 Clinical Trial

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 Details — Status: Recruiting

Administrative data
NCT number NCT05451303
Other study ID # V300
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 27, 2022
Est. completion date December 2025

Study information
Verified date December 2023
Source Viome
Contact Mory Mehrtash, MSc
Phone 425-300-6933
Email studies@viome.com
Is FDA regulated No
Health authority
Study type Observational

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.

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 information / eligibility
Status Recruiting
Enrollment 475
Est. completion date December 2025
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria for participants in OSCC or OPC cohorts - Participants must be diagnosed with oral squamous cell carcinoma (OSCC) and/or OroPharyngeal cancer (OPC) - Aged 18 years or older - Signed and dated informed consent prior to any study-specific procedures are performed - Willing and able to follow the study instructions, as described in the recruitment letter Exclusion Criteria for participants in OSCC or OPC cohorts - Pregnancy - Use of fertility enhancing medications - Active infection Inclusion Criteria for participants in OPMD cohorts - Any Oral Premalignant Disorder (OPMD) - Dysplasia - Hyperplasia - Leukoplakia - Erythroplasia - Lichenoid lesions - Actinic Keratosis - Lichenoid reaction - Aphthous ulcer/ Canker Sores - Gingival enlargement (side effect) - Lichen planus - Keratosis - Inflammatory reaction - Cheek bites - Aged =50 years OR aged 18 years or older with a history of tobacco use (see above) - Signed and dated informed consent prior to any study-specific procedures are performed - Willing and able to follow the study instructions, as described in the recruitment letter Exclusion Criteria for participants in OPMD cohorts - Pregnancy - Use of fertility enhancing medications - Active infection Inclusion Criteria for participants in cancer-free cohorts - Aged = 50 years OR aged 18 years or older with a history of tobacco use - Signed and dated informed consent prior to any study-specific procedures are performed - Willing and able to follow the study instructions, as described in the recruitment letter Exclusion criteria for participants in cancer-free cohorts - Pregnancy - Use of fertility enhancing medications - Active infection

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States NYMC New York New York

Sponsors (2)
Lead Sponsor Collaborator
Viome New York Medical College

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The primary endpoint will be the detection or not of OSCC or OPC The test results will be compared against the definitive diagnosis by the physician. 1 year
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