Validity of Viome's Oral/Throat Cancer Test

Study Overview
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Brief Summary
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A total of at least 1,000 participants with suspicion of cancer including at least 107 subjects who will be diagnosed with OSCC or OPSCC will be enrolled from either primary or secondary care centers in the U.S. Clinicians will use Viome collection kits to collect saliva samples from eligible patients.

Detailed Description
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This is a prospective, observational, multi-center study. Subjects with OSCC or OPSCC will be enrolled from two to four primary and secondary care centers in the U.S. Study samples will be collected by the clinicians at the study sites using Viome saliva sample collection kits. Patients will continue with their current health plan and confirm diagnosis following the standard of care of surgical biopsy with histology if needed. If a biopsy is performed, the result of the biopsy will be compared with the result of the Viome kit. If no biopsy is performed, the Viome test result will be compared with the physician's assessment based on clinical judgment. Patients with a positive result from histology will not receive the results of the Viome kit, and it will not play any part in the clinical management of the patients.

Official Title
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Validity of Viome's Oral/Throat Cancer Test Among Patients With a Suspicion of Cancer

Conditions
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Oral and Throat Cancer, Oropharyngeal Squamous Cell Carcinoma, Oral Squamous Cell Carcinoma

Intervention / Treatment
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* Device: Oral/Throat cancer test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Suspicion of OSCC or OPSCC on clinical presentation Exclusion Criteria: Pregnancy Use of fertility enhancing medications Active infection (except for HPV)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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 either primary or secondary care. | Device: Oral/Throat cancer test<br>* The Oral/Throat cancer test is intended for the qualitative detection of molecular features (human genes, microbial species and functions) associated with Oral Squamous Cell Carcinoma (OSCC) or OroPharyngeal Squamous Cell Carcinoma (OPSCC) in saliva samples from adults with a suspicion of cancer. A positive result from CDOT may indicate the presence of OSCC or OPSCC. The device is intended as a diagnostic aid for clinicians when assessing patients with suspected OSCC or OPSCC who may benefit from follow-up diagnosis and treatment. The device is not intended for a definitive diagnosis.<br>|
| Oropharyngeal Squamous Cell Carcinoma (OPSCC)<br>OPSCC case cohort will consist of patients with Oral Squamous Cell Carcinoma (all stages, locations), recruited from either primary or secondary care. | Device: Oral/Throat cancer test<br>* The Oral/Throat cancer test is intended for the qualitative detection of molecular features (human genes, microbial species and functions) associated with Oral Squamous Cell Carcinoma (OSCC) or OroPharyngeal Squamous Cell Carcinoma (OPSCC) in saliva samples from adults with a suspicion of cancer. A positive result from CDOT may indicate the presence of OSCC or OPSCC. The device is intended as a diagnostic aid for clinicians when assessing patients with suspected OSCC or OPSCC who may benefit from follow-up diagnosis and treatment. The device is not intended for a definitive diagnosis.<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 and secondary care facilities. | Device: Oral/Throat cancer test<br>* The Oral/Throat cancer test is intended for the qualitative detection of molecular features (human genes, microbial species and functions) associated with Oral Squamous Cell Carcinoma (OSCC) or OroPharyngeal Squamous Cell Carcinoma (OPSCC) in saliva samples from adults with a suspicion of cancer. A positive result from CDOT may indicate the presence of OSCC or OPSCC. The device is intended as a diagnostic aid for clinicians when assessing patients with suspected OSCC or OPSCC who may benefit from follow-up diagnosis and treatment. The device is not intended for a definitive diagnosis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint will be whether or not OSCC or OPSCC is detected using Viome's oral/throat cancer test | The primary endpoint will be the detection or not of a molecular signature associated with OSCC or OPSCC when compared against the results of biopsy or clinical judgment when biopsy is not performed. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OSCC, OPSCC, Oral Cancer, Throat cancer, Oral and Throat cancer