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| Name | Class |
|---|---|
| New York Medical College | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Squamous Cell Carcinoma (OSCC) | OSCC case cohort will consist of patients with Oral Squamous Cell Carcinoma (all stages, locations), recruited from secondary care. |
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| OroPharyngeal Cancer (OPC) | OPC case cohort will consist of patients with OroPharyngeal cancer (all stages, locations), recruited from secondary care. |
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| Oral Potentially Malignant Disease (OPMD) | OPMD cohort will consist of patients with both potential malignancies or benign conditions including, but not limited to:
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| Cancer-free | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OralViome Cancer Testing System | Device | 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. |
| 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 |
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Inclusion Criteria
Exclusion Criteria
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Participants will be recruited into one of four cohorts, OSCC, OPC, OPMD, or cancer free cohorts.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mory Mehrtash, MSc | Contact | 425-300-6933 | studies@viome.com | |
| Momchilo Vuyisich, PhD | Contact | 425-300-6933 | studies@viome.com |
| Name | Affiliation | Role |
|---|---|---|
| Cristina Julian, PhD | Viome | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYMC | Recruiting | New York | New York | 10595 | United States |
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| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D009062 | Mouth Neoplasms |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |