Validity of Viome's Oral/throat Cancer Test

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.

Study Overview

• Status: Recruiting
• Conditions: Oropharyngeal Squamous Cell Carcinoma; Oral Squamous Cell Carcinoma; Oral and Throat Cancer
• Intervention / Treatment: Device: Oral/Throat cancer test

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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Mory Mehrtash; Phone Number: 425-300-6933; Email: studies@viome.com
• Study Contact Backup: Name: Momchilo Vuyisich; Phone Number: 425-300-6933; Email: studies@viome.com

Study Locations

• United States
  • Missouri
    • St. Louis, Missouri, United States, 63104
      • Recruiting
      • Missouri School of Dentistry & Oral Health
      • Contact: Adepitan Owosho; Phone Number: 314-833-2729; Email: adepitanowosho@atsu.edu
  • Tennessee
    • Memphis, Tennessee, United States, 38163
      • Recruiting
      • UTHSC
      • Contact: Yanhui Zhang, Ph.D.; Phone Number: 901.448.3751; Email: yzhang36@uthsc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Pregnancy
• Use of fertility enhancing medications

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Oral/Throat cancer test; 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.
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.	Device: Oral/Throat cancer test; 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.
Cancer-free; Participants will be recruited following clinical adjudication with self-reported confirmation of no cancer and from primary and secondary care facilities.	Device: Oral/Throat cancer test; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity	Oral/Throat cancer test's ability to designate an individual with disease as positive	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	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	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	Through study completion, an average of 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity by care center (primary and secondary)	Oral/Throat cancer test's ability to designate an individual with disease as positive	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	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	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	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	Through study completion, an average of 18 months
Sensitivity by oral cancer type (OSCC or OPSCC)	One measure post treatment	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	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	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	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	Through study completion, an average of 18 months
Specificity by care center (primary and secondary)	One measure post treatment	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	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	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	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	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	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	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	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	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	Through study completion, an average of 18 months

Collaborators and Investigators

• Sponsor: Viome
• Investigators: Principal Investigator: Cristina Julian, Viome

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 8, 2023
• First Submitted That Met QC Criteria: December 8, 2023
• First Posted (Actual): December 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 27, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Oral Cancer; OPSCC; OSCC; Throat cancer; Oral and Throat cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Carcinoma; Carcinoma, Squamous Cell
• Other Study ID Numbers: V303

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No