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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.
This is a prospective, multi-center study. Subjects with OSCC or OPSCC will be enrolled from 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.
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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 either primary or secondary care. |
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| Oropharyngeal Squamous Cell Carcinoma (OPSCC) | OPSCC case cohort will consist of patients with Oral Squamous Cell Carcinoma (all stages, locations), recruited from either primary or secondary care. |
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| Cancer-free | Participants will be recruited following clinical adjudication with self-reported confirmation of no cancer and from primary and secondary care facilities. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral/Throat cancer test | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity | Oral/Throat cancer test's ability to designate an individual with disease as positive | Through study completion, an average of 18 months |
| Specificity | Oral/Throat cancer test's ability to designate an individual who does not have a disease as negative | Through study completion, an average of 18 months |
| Positive Post Test Probability (PPV) | The probability of having the target condition if the test falls out positive | Through study completion, an average of 18 months |
| Negative Post Test Probability (NPV) | The probability of having the target condition if the test falls out negative | Through study completion, an average of 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity by care center (primary and secondary) | Oral/Throat cancer test's ability to designate an individual with disease as positive | Through study completion, an average of 18 months |
| Sensitivity by age |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will comprise patients who attend (1) a primary care center (typically dentist offices) and are identified with a suspicion of cancer based on a clinical presentation or (2) a secondary care center (typically hospitals) following the finding of a suspicious lesion or symptom. Secondary care centers include clinical sites where specialists such as oncologists or oral and maxillofacial surgeons (also called head and neck surgeons) perform visual and tactile oral examinations and biopsies to detect oral cancer. They are also known as ear, nose, and throat (ENT) doctors or otolaryngologists.
Women or minorities are not excluded from this study. In order to calculate an estimated number of samples in each demographic category we performed stratified random sampling. We used the SEER Program to calculate oral and throat cancer prevalence for each of the demographic categories.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mory Mehrtash | Contact | 425-300-6933 | studies@viome.com | |
| Momchilo Vuyisich | Contact | 425-300-6933 | studies@viome.com |
| Name | Affiliation | Role |
|---|---|---|
| Cristina Julian | Viome | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Missouri School of Dentistry & Oral Health | Recruiting | St Louis | Missouri | 63104 | 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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The Oral/Throat cancer test is intended for the qualitative detection of molecular features (human genes, microbial species and functions) associated with OSCC or OPSCC in saliva samples from adults with a suspicion of cancer. The system consists of the 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.
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Oral/Throat cancer test's ability to designate an individual with disease as positive
| Through study completion, an average of 18 months |
| Sensitivity by sex | Oral/Throat cancer test's ability to designate an individual with disease as positive | Through study completion, an average of 18 months |
| Sensitivity by race | Oral/Throat cancer test's ability to designate an individual with disease as positive | Through study completion, an average of 18 months |
| Sensitivity by smoking history | Oral/Throat cancer test's ability to designate an individual with disease as positive | Through study completion, an average of 18 months |
| Sensitivity by oral cancer type (OSCC or OPSCC) | One measure post treatment | Through study completion, an average of 18 months |
| Sensitivity by disease stage (I, II, III, and IV) | Oral/Throat cancer test's ability to designate an individual with disease as positive | Through study completion, an average of 18 months |
| Sensitivity by metastasis | Oral/Throat cancer test's ability to designate an individual with disease as positive | Through study completion, an average of 18 months |
| Sensitivity by HPV status | Oral/Throat cancer test's ability to designate an individual with disease as positive | Through study completion, an average of 18 months |
| Sensitivity by recurrent cancer | Oral/Throat cancer test's ability to designate an individual with disease as positive | Through study completion, an average of 18 months |
| Specificity by care center (primary and secondary) | One measure post treatment | Through study completion, an average of 18 months |
| Specificity by age | Oral/Throat cancer test's ability to designate an individual who does not have a disease as negative | Through study completion, an average of 18 months |
| Specificity by sex | Oral/Throat cancer test's ability to designate an individual who does not have a disease as negative | Through study completion, an average of 18 months |
| Specificity by race | Oral/Throat cancer test's ability to designate an individual who does not have a disease as negative | Through study completion, an average of 18 months |
| Specificity by smoking history | Oral/Throat cancer test's ability to designate an individual who does not have a disease as negative | Through study completion, an average of 18 months |
| Specificity by oral cancer type (OSCC or OPSCC) | Oral/Throat cancer test's ability to designate an individual who does not have a disease as negative | Through study completion, an average of 18 months |
| Specificity by disease stage (I, II, III, and IV) | Oral/Throat cancer test's ability to designate an individual who does not have a disease as negative | Through study completion, an average of 18 months |
| Specificity by metastasis | Oral/Throat cancer test's ability to designate an individual who does not have a disease as negative | Through study completion, an average of 18 months |
| Specificity by HPV status | Oral/Throat cancer test's ability to designate an individual who does not have a disease as negative | Through study completion, an average of 18 months |
| Specificity by recurrent cancer | Oral/Throat cancer test's ability to designate an individual who does not have a disease as negative | Through study completion, an average of 18 months |
| UTHSC | Recruiting | Memphis | Tennessee | 38163 | United States |
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| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |