Detection of Oral and Throat Cancers Using OralViome Cancer Testing System

Sponsor

Viome (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05451303

Collaborator

New York Medical College (Other)

475

Enrollment

Location

11.1

Anticipated Duration (Months)

42.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oral Squamous Cell Carcinoma Oropharynx Squamous Cell Carcinoma Premalignant Lesion	Device: OralViome Cancer Testing System

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

Study Type:

Observational

Anticipated Enrollment :

475 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Detection of Oral and Throat Cancers Using Saliva Metatranscriptomic Analysis

Actual Study Start Date :

May 27, 2022

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Oral Squamous Cell Carcinoma (OSCC) OSCC case cohort will consist of patients with Oral Squamous Cell Carcinoma (all stages, locations), recruited from secondary care.	Device: 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.	Device: 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	Device: 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.	Device: 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.

Outcome Measures

Primary Outcome Measures

The primary endpoint will be the detection or not of OSCC or OPC [1 year]
The test results will be compared against the definitive diagnosis by the physician.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria for participants in OSCC or OPC cohorts

Participants must be diagnosed with oral squamous cell carcinoma (OSCC) and/or OroPharyngeal cancer (OPC)
Aged 18 years or older
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

Exclusion Criteria for participants in OSCC or OPC cohorts

Pregnancy
Use of fertility enhancing medications
Active infection

Inclusion Criteria for participants in OPMD cohorts

Any Oral Premalignant Disorder (OPMD)
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
Aged ≥50 years OR aged 18 years or older with a history of tobacco use (see above)
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

Exclusion Criteria for participants in OPMD cohorts

Pregnancy
Use of fertility enhancing medications
Active infection

Inclusion Criteria for participants in cancer-free cohorts

Aged ≥ 50 years OR aged 18 years or older with a history of tobacco use
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

Exclusion criteria for participants in cancer-free cohorts