Detection of Oral and Throat Cancers Using OralViome Cancer Testing System
NCT ID: NCT05451303
Last Updated: 2025-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
475 participants
OBSERVATIONAL
2022-05-27
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Oral Squamous Cell Carcinoma (OSCC)
OSCC case cohort will consist of patients with Oral Squamous Cell Carcinoma (all stages, locations), recruited from secondary care.
OralViome Cancer Testing System
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.
OroPharyngeal Cancer (OPC)
OPC case cohort will consist of patients with OroPharyngeal cancer (all stages, locations), recruited from secondary care.
OralViome Cancer Testing System
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.
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
OralViome Cancer Testing System
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.
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.
OralViome Cancer Testing System
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.
Interventions
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OralViome Cancer Testing System
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
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Inclusion Criteria
* 18 years and older
* At a high risk of developing oral or throat cancer based on clinician's discretion
Exclusion Criteria
* Use of fertility enhancing medications
18 Years
ALL
Yes
Sponsors
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New York Medical College
OTHER
Viome
INDUSTRY
Responsible Party
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Principal Investigators
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Cristina Julian, PhD
Role: PRINCIPAL_INVESTIGATOR
Viome
Locations
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NYMC
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Mohanapriya Rajamoorthy
Role: primary
Other Identifiers
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V300
Identifier Type: -
Identifier Source: org_study_id
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