Oral Squamous Cell CarcinomaNCT05451303
Detection of Oral and Throat Cancers Using OralViome Cancer Testing System
An observational study of Oral Squamous Cell Carcinoma and Oropharynx Squamous Cell Carcinoma, run by Viome at 1 site in United States.
Trial summary
To evaluate the design, safety and efficacy of OralViome Cancer Testing system in the early detection of Oral and Throat Cancers using saliva metatranscriptomic analysis. This study will recruit only at existing clinical sites and will NOT use any additional clinical sites. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Squamous Cell Carcinoma, Oropharynx Squamous Cell Carcinoma, Premalignant Lesion
- What is being tested?
- OralViome Cancer Testing System
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 475 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2022to 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be recruited into one of four cohorts, OSCC, OPC, OPMD, or cancer free cohorts.
Who may be able to join
- Signed Informed Consent obtained
- 18 years and older
- At a high risk of developing oral or throat cancer based on clinician's discretion
Who cannot join
- Pregnancy
- Use of fertility enhancing medications
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYMC
New York, New York, 10595
Mohanapriya Rajamoorthy, (914) 594-4575
About this study
Official title: Detection of Oral and Throat Cancers Using Saliva Metatranscriptomic Analysis
To evaluate the design, safety and efficacy of OralViome Cancer Testing system in the early detection of Oral and Throat Cancers using saliva metatranscriptomic analysis. This study will recruit only at existing clinical sites and will NOT use any additional clinical sites.
Read the detailed description
This is an observational study evaluating the design, safety and efficacy of OralViome Cancer Testing system in the early detection of Oral and Throat Cancers using saliva metatranscriptomic.
A total of 475 participants will be recruited, including 4 different cohorts: 1) cancer free patients, 2) patients with Oral Potentially Malignant Disease (OPMD), 3) patients with Oral Squamous Cell Carcinoma (OSCC), and 4) patients with OroPharyngeal Cancer (OPC). OSCC and OPC participants will be recruited from secondary care facilities, OPMD and cancer free participants will be recruited from primary care facilities.
Participants will complete health questionnaires and collect saliva samples using at home/ in clinic kits provided by Viome. The duration of study participation will be 1 clinic visit for cancer free participants, and up to 1 year for those with OSCC/OPC/OPMD.
- Being tested
- OralViome Cancer Testing System
- Keywords
- Viome, oral cancer, detection, OSCC, OPMD-B, OPMD-PM, OPMD, OPV, Tobacco, HPV
- 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.
OralViome Cancer Testing SystemDevice
The OralViome Cancer Testing System is intended for the screening of Oral Squamous Cell Carcinoma (OSCC) and Oropharyngeal cancer (OPC). The system consists of the OralViome 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.
| 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 secondary care. Receives: Device: OralViome Cancer Testing System | |
| OroPharyngeal Cancer (OPC) | OPC case cohort will consist of patients with OroPharyngeal cancer (all stages, locations), recruited from secondary care. Receives: Device: OralViome Cancer Testing System | |
| Oral Potentially Malignant Disease (OPMD) | OPMD cohort will consist of patients with both potential malignancies or benign conditions including, but not limited to:
* Dysplasia
* Hyperplasia
* Leukoplakia
* Erythroplasia
* Lichenoid lesions
* Actinic Keratosis
* Lichenoid reaction
* Aphthous ulcer/ Canker Sores
* Gingival enlargement (side effect)
* Lichen planus
* Keratosis
* Inflammatory reaction
* Cheek bites Receives: Device: OralViome Cancer Testing System | |
| Cancer-free | Cancer free control cohort will be matched with cases. Participants will be recruited following clinical adjudication with self-reported confirmation of no cancer and from primary care facilities. Receives: Device: OralViome Cancer Testing System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will be the detection or not of OSCC or OPC
The test results will be compared against the definitive diagnosis by the physician.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start27 May 2022
- 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 Squamous Cell CarcinomaStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 475 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Viome
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- New York Medical College
- Responsible party
- Sponsor
- Investigators
- Cristina Julian, PhD, Principal investigator, Viome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05451303
- Sponsor's protocol ID
- V300
- Status last verified
- Jan 2025
- First submitted
- 5 Jul 2022
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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
- Detection of Oral and Throat Cancers Using Saliva Metatranscriptomic Analysis
- ClinicalTrials.gov ID
- NCT05451303
- Acronym / sponsor ID
- V300
- Keywords
- Viome, oral cancer, detection, OSCC, OPMD-B, OPMD-PM, OPMD, OPV
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 475 participants (estimated)
- Lead sponsor
- ViomeIndustry (pharma, biotech, devices)
- Collaborators
- New York Medical College
- Study start
- 27 May 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Jul 2022 (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.
To evaluate the design, safety and efficacy of OralViome Cancer Testing system in the early detection of Oral and Throat Cancers using saliva metatranscriptomic analysis. This study will recruit only at existing clinical sites and will NOT use any additional clinical sites.
Detailed description
This is an observational study evaluating the design, safety and efficacy of OralViome Cancer Testing system in the early detection of Oral and Throat Cancers using saliva metatranscriptomic.
A total of 475 participants will be recruited, including 4 different cohorts: 1) cancer free patients, 2) patients with Oral Potentially Malignant Disease (OPMD), 3) patients with Oral Squamous Cell Carcinoma (OSCC), and 4) patients with OroPharyngeal Cancer (OPC). OSCC and OPC participants will be recruited from secondary care facilities, OPMD and cancer free participants will be recruited from primary care facilities.
Participants will complete health questionnaires and collect saliva samples using at home/ in clinic kits provided by Viome. The duration of study participation will be 1 clinic visit for cancer free participants, and up to 1 year for those with OSCC/OPC/OPMD.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Oral Squamous Cell Carcinoma (OSCC) | – | Device: OralViome Cancer Testing SystemOSCC case cohort will consist of patients with Oral Squamous Cell Carcinoma (all stages, locations), recruited from secondary care. |
| OroPharyngeal Cancer (OPC) | – | Device: OralViome Cancer Testing SystemOPC case cohort will consist of patients with OroPharyngeal cancer (all stages, locations), recruited from secondary care. |
| Oral Potentially Malignant Disease (OPMD) | – | Device: OralViome Cancer Testing SystemOPMD cohort will consist of patients with both potential malignancies or benign conditions including, but not limited to: * Dysplasia * Hyperplasia * Leukoplakia * Erythroplasia * Lichenoid lesions * Actinic Keratosis * Lichenoid reaction * Aphthous ulcer/ Canker Sores * Gingival enlargement (side effect) * Lichen planus * Keratosis * Inflammatory reaction * Cheek bites |
| Cancer-free | – | Device: OralViome Cancer Testing SystemCancer free control cohort will be matched with cases. Participants will be recruited following clinical adjudication with self-reported confirmation of no cancer and from primary care facilities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited into one of four cohorts, OSCC, OPC, OPMD, or cancer free cohorts.
Key inclusion criteria (3 listed)
- Signed Informed Consent obtained
- 18 years and older
- At a high risk of developing oral or throat cancer based on clinician's discretion
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 |
|---|---|---|
| OralViome Cancer Testing SystemThe OralViome Cancer Testing System is intended for the screening of Oral Squamous Cell Carcinoma (OSCC) and Oropharyngeal cancer (OPC). The system consists of the OralViome 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. | Device | Cancer-free, Oral Potentially Malignant Disease (OPMD), Oral Squamous Cell Carcinoma (OSCC), OroPharyngeal Cancer (OPC) |
Primary outcome
The primary endpoint will be the detection or not of OSCC or OPC
Time frame: 1 year
The test results will be compared against the definitive diagnosis by the physician.
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.
- Individual participant dataSharing planned: No
Related trials for Oral Squamous Cell Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 3
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma
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, PhD principal investigator
Viome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Squamous Cell Carcinoma and Oropharynx Squamous Cell Carcinoma, run by Viome at 1 site 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 3 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 1 site 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, MSc (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?
The primary endpoint will be the detection or not of OSCC or OPC (time frame: 1 year). 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.