Validity of Viome's Oral/throat Cancer Test
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorViome
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Pregnancy
Use of fertility enhancing medications
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Oral/Throat cancer test
DeviceThe 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.
Treatment groups
1,000 Participants
are divided into 3 treatment groupsGroup A: Oral Squamous Cell Carcinoma (OSCC)1 intervention
Group B: Oropharyngeal Squamous Cell Carcinoma (OPSCC)1 intervention
Group C: Cancer-free1 intervention
Trial outcomes
Primary outcomes
1
Sensitivity
Oral/Throat cancer test's ability to designate an individual with disease as positive
Time frame
Through study completion, an average of 18 months2
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 months3
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 months4
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 monthsSecondary outcomes
1
Sensitivity by care center (primary and secondary)
Oral/Throat cancer test's ability to designate an individual with disease as positive
Time frame
Through study completion, an average of 18 months2
Sensitivity by age
Oral/Throat cancer test's ability to designate an individual with disease as positive
Time frame
Through study completion, an average of 18 months3
Sensitivity by sex
Oral/Throat cancer test's ability to designate an individual with disease as positive
Time frame
Through study completion, an average of 18 months4
Sensitivity by race
Oral/Throat cancer test's ability to designate an individual with disease as positive
Time frame
Through study completion, an average of 18 months Source ClinicalTrials.gov