Oral and Throat CancerNCT06174428
Validity of Viome's Oral/throat Cancer Test
An observational study of Oral and Throat Cancer and Oropharyngeal Squamous Cell Carcinoma, run by Viome at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral and Throat Cancer, Oropharyngeal Squamous Cell Carcinoma, Oral Squamous Cell Carcinoma
- What is being tested?
- Oral/Throat cancer test
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 1,000 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Jan 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Use of fertility enhancing medications
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
UTHSC
Memphis, Tennessee, 38163
Yanhui Zhang, Ph.D., 901.448.3751, yzhang36@uthsc.edu
- Recruiting
Missouri School of Dentistry & Oral Health
St Louis, Missouri, 63104
Adepitan Owosho, 314-833-2729, adepitanowosho@atsu.edu
About this study
Official title: Validity of Viome's Oral/throat Cancer Test Among Patients with a Suspicion of Cancer
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.
Read the 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.
- Conditions
- Oral and Throat Cancer, Oropharyngeal Squamous Cell Carcinoma, Oral Squamous Cell Carcinoma
- Being tested
- Oral/Throat cancer test
- Keywords
- OSCC, OPSCC, Oral Cancer, Throat cancer, Oral and Throat cancer
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral/Throat cancer testDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Oral/Throat cancer test | |
| 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. Receives: Device: Oral/Throat cancer test | |
| Cancer-free | Participants will be recruited following clinical adjudication with self-reported confirmation of no cancer and from primary and secondary care facilities. Receives: Device: Oral/Throat cancer test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Oral/Throat cancer test's ability to designate an individual with disease as positive
Measured: 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
Measured: 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
Measured: 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
Measured: Through study completion, an average of 18 months
Secondary outcomes (20)
Sensitivity by care center (primary and secondary)
Oral/Throat cancer test's ability to designate an individual with disease as positive
Measured: Through study completion, an average of 18 months
Sensitivity by age
Oral/Throat cancer test's ability to designate an individual with disease as positive
Measured: 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
Measured: 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
Measured: 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
Measured: Through study completion, an average of 18 months
Sensitivity by oral cancer type (OSCC or OPSCC)
One measure post treatment
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Through study completion, an average of 18 months
Specificity by care center (primary and secondary)
One measure post treatment
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Through study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start27 Jan 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral and Throat CancerStudies of the same condition, open and under way.
- More trials run by ViomeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Viome
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cristina Julian, Principal investigator, Viome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174428
- Sponsor's protocol ID
- V303
- Status last verified
- Jan 2025
- First submitted
- 8 Dec 2023
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of Viome's Oral/throat Cancer Test Among Patients with a Suspicion of Cancer
- ClinicalTrials.gov ID
- NCT06174428
- Acronym / sponsor ID
- V303
- Conditions
- Oral and Throat Cancer, Oropharyngeal Squamous Cell Carcinoma, Oral Squamous Cell Carcinoma
- Keywords
- OSCC, OPSCC, Oral Cancer, Throat cancer, Oral and Throat cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- ViomeIndustry (pharma, biotech, devices)
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oral Squamous Cell Carcinoma (OSCC) | – | Device: Oral/Throat cancer testOSCC case cohort will consist of patients with Oral Squamous Cell Carcinoma (all stages, locations), recruited from either primary or secondary care. |
| Oropharyngeal Squamous Cell Carcinoma (OPSCC) | – | Device: Oral/Throat cancer testOPSCC case cohort will consist of patients with Oral Squamous Cell Carcinoma (all stages, locations), recruited from either primary or secondary care. |
| Cancer-free | – | Device: Oral/Throat cancer testParticipants will be recruited following clinical adjudication with self-reported confirmation of no cancer and from primary and secondary care facilities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnancy
- Use of fertility enhancing medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral/Throat cancer testThe 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. | Device | Cancer-free, Oral Squamous Cell Carcinoma (OSCC), Oropharyngeal Squamous Cell Carcinoma (OPSCC) |
Primary outcome
Sensitivity
Time frame: Through study completion, an average of 18 months
Oral/Throat cancer test's ability to designate an individual with disease as positive
Specificity
Time frame: 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)
Time frame: 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)
Time frame: Through study completion, an average of 18 months
The probability of having the target condition if the test falls out negative
20 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cristina Julian principal investigator
Viome
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral and Throat Cancer and Oropharyngeal Squamous Cell Carcinoma, run by Viome at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mory Mehrtash (425-300-6933, studies@viome.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: Through study completion, an average of 18 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.