Detection of Oral and Throat Cancers Using OralViome Cancer Testing System
1 other identifier
observational
475
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 27, 2022
CompletedFirst Submitted
Initial submission to the registry
July 5, 2022
CompletedFirst Posted
Study publicly available on registry
July 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
January 29, 2025
January 1, 2025
4.5 years
July 5, 2022
January 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1 year
Study Arms (4)
Oral Squamous Cell Carcinoma (OSCC)
OSCC case cohort will consist of patients with Oral Squamous Cell Carcinoma (all stages, locations), recruited from secondary care.
OroPharyngeal Cancer (OPC)
OPC case cohort will consist of patients with OroPharyngeal cancer (all stages, locations), recruited from secondary care.
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
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.
Interventions
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.
Eligibility Criteria
Participants will be recruited into one of four cohorts, OSCC, OPC, OPMD, or cancer free cohorts.
You may qualify if:
- Signed Informed Consent obtained
- years and older
- At a high risk of developing oral or throat cancer based on clinician's discretion
You may not qualify if:
- Pregnancy
- Use of fertility enhancing medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Viomelead
- New York Medical Collegecollaborator
Study Sites (1)
NYMC
New York, New York, 10595, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cristina Julian, PhD
Viome
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2022
First Posted
July 11, 2022
Study Start
May 27, 2022
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
January 29, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share