Detection of Oral and Throat Cancers Using OralViome Cancer Testing System

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Oral Squamous Cell Carcinoma, Oropharynx Squamous Cell Carcinoma, Premalignant Lesion

Intervention / Treatment
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* Device: OralViome Cancer Testing System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Oral Squamous Cell Carcinoma (OSCC)<br>OSCC case cohort will consist of patients with Oral Squamous Cell Carcinoma (all stages, locations), recruited from secondary care. | Device: OralViome Cancer Testing System<br>* 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.<br>|
| OroPharyngeal Cancer (OPC)<br>OPC case cohort will consist of patients with OroPharyngeal cancer (all stages, locations), recruited from secondary care. | Device: OralViome Cancer Testing System<br>* 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.<br>|
| Oral Potentially Malignant Disease (OPMD)<br>OPMD cohort will consist of patients with both potential malignancies or benign conditions including, but not limited to: 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 | Device: OralViome Cancer Testing System<br>* 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.<br>|
| Cancer-free<br>Cancer free control cohort will be matched with cases. Participants will be recruited following clinical adjudication with self-reported confirmation of no cancer and from primary care facilities. | Device: OralViome Cancer Testing System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Viome, oral cancer, detection, OSCC, OPMD-B, OPMD-PM, OPMD, OPV, Tobacco, HPV