Oral and Throat Cancer, Oral Squamous Cell Carcinoma, Oropharyngeal Squamous Cell Carcinoma
Conditions
Keywords
OSCC, OPSCC, Oral Cancer, Throat cancer, Oral and Throat cancer
Brief summary
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
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.
Interventions
DEVICEOral/Throat cancer test
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.
Sponsors
Viome
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 * Adults (18 years old or older) * Suspicion of OSCC or OPSCC on clinical presentation by a clinician
Exclusion criteria
* Pregnancy * Use of fertility enhancing medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity | Through study completion, an average of 18 months | Oral/Throat cancer test's ability to designate an individual with disease as positive |
| Specificity | Through study completion, an average of 18 months | Oral/Throat cancer test's ability to designate an individual who does not have a disease as negative |
| Positive Post Test Probability (PPV) | Through study completion, an average of 18 months | The probability of having the target condition if the test falls out positive |
| Negative Post Test Probability (NPV) | Through study completion, an average of 18 months | The probability of having the target condition if the test falls out negative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity by smoking history | Through study completion, an average of 18 months | Oral/Throat cancer test's ability to designate an individual with disease as positive |
| Sensitivity by oral cancer type (OSCC or OPSCC) | Through study completion, an average of 18 months | One measure post treatment |
| Sensitivity by disease stage (I, II, III, and IV) | Through study completion, an average of 18 months | Oral/Throat cancer test's ability to designate an individual with disease as positive |
| Sensitivity by metastasis | Through study completion, an average of 18 months | Oral/Throat cancer test's ability to designate an individual with disease as positive |
| Sensitivity by HPV status | Through study completion, an average of 18 months | Oral/Throat cancer test's ability to designate an individual with disease as positive |
| Sensitivity by recurrent cancer | Through study completion, an average of 18 months | Oral/Throat cancer test's ability to designate an individual with disease as positive |
| Specificity by care center (primary and secondary) | Through study completion, an average of 18 months | One measure post treatment |
| Specificity by age | Through study completion, an average of 18 months | Oral/Throat cancer test's ability to designate an individual who does not have a disease as negative |
| Sensitivity by care center (primary and secondary) | Through study completion, an average of 18 months | Oral/Throat cancer test's ability to designate an individual with disease as positive |
| Specificity by race | Through study completion, an average of 18 months | Oral/Throat cancer test's ability to designate an individual who does not have a disease as negative |
| Specificity by smoking history | Through study completion, an average of 18 months | Oral/Throat cancer test's ability to designate an individual who does not have a disease as negative |
| Specificity by oral cancer type (OSCC or OPSCC) | Through study completion, an average of 18 months | Oral/Throat cancer test's ability to designate an individual who does not have a disease as negative |
| Specificity by disease stage (I, II, III, and IV) | Through study completion, an average of 18 months | Oral/Throat cancer test's ability to designate an individual who does not have a disease as negative |
| Specificity by metastasis | Through study completion, an average of 18 months | Oral/Throat cancer test's ability to designate an individual who does not have a disease as negative |
| Specificity by HPV status | Through study completion, an average of 18 months | Oral/Throat cancer test's ability to designate an individual who does not have a disease as negative |
| Specificity by recurrent cancer | Through study completion, an average of 18 months | Oral/Throat cancer test's ability to designate an individual who does not have a disease as negative |
| Specificity by sex | Through study completion, an average of 18 months | Oral/Throat cancer test's ability to designate an individual who does not have a disease as negative |
| Sensitivity by age | Through study completion, an average of 18 months | Oral/Throat cancer test's ability to designate an individual with disease as positive |
| Sensitivity by sex | Through study completion, an average of 18 months | Oral/Throat cancer test's ability to designate an individual with disease as positive |
| Sensitivity by race | Through study completion, an average of 18 months | Oral/Throat cancer test's ability to designate an individual with disease as positive |
Countries
United States
Contacts
Primary ContactMory Mehrtash
Backup ContactMomchilo Vuyisich
Outcome results
None listed