Validity of Viome's Oral/throat Cancer Test Among Patients with a Suspicion of Cancer
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.
Arms & 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.
Outcome measures
Primary
Sensitivity
Oral/Throat cancer test's ability to designate an individual with disease as positive
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Through study completion, an average of 18 months
Secondary
Sensitivity by care center (primary and secondary)
Time frame: Through study completion, an average of 18 months
Sensitivity by age
Time frame: Through study completion, an average of 18 months
Sensitivity by sex
Time frame: Through study completion, an average of 18 months
Sensitivity by race
Time frame: Through study completion, an average of 18 months
Sensitivity by smoking history
Time frame: Through study completion, an average of 18 months
Sensitivity by oral cancer type (OSCC or OPSCC)
Time frame: Through study completion, an average of 18 months
Sensitivity by disease stage (I, II, III, and IV)
Time frame: Through study completion, an average of 18 months
Sensitivity by metastasis
Time frame: Through study completion, an average of 18 months
Sensitivity by HPV status
Time frame: Through study completion, an average of 18 months
Sensitivity by recurrent cancer
Time frame: Through study completion, an average of 18 months
Specificity by care center (primary and secondary)
Time frame: Through study completion, an average of 18 months
Specificity by age
Time frame: Through study completion, an average of 18 months
Specificity by sex
Time frame: Through study completion, an average of 18 months
Specificity by race
Time frame: Through study completion, an average of 18 months
Specificity by smoking history
Time frame: Through study completion, an average of 18 months
Specificity by oral cancer type (OSCC or OPSCC)
Time frame: Through study completion, an average of 18 months
Specificity by disease stage (I, II, III, and IV)
Time frame: Through study completion, an average of 18 months
Specificity by metastasis
Time frame: Through study completion, an average of 18 months
Specificity by HPV status
Time frame: Through study completion, an average of 18 months
Specificity by recurrent cancer
Time frame: Through study completion, an average of 18 months
Eligibility criteria
Study locations (2)
Missouri School of Dentistry & Oral Health
St Louis, Missouri, 63104
UTHSC
Memphis, Tennessee, 38163