Validity of Viome's Oral/throat Cancer Test

NCT06174428 | Recruiting

• 1 other identifier: V303
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Oral and Throat Cancer; Oropharyngeal Squamous Cell Carcinoma; Oral Squamous Cell Carcinoma

Keywords

OSCC; OPSCC; Oral Cancer; Throat cancer; Oral and Throat cancer

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (20)

• Sensitivity by care center (primary and secondary)

  Through study completion, an average of 18 months

• Sensitivity by age

  Through study completion, an average of 18 months

• Sensitivity by sex

  Through study completion, an average of 18 months

• Sensitivity by race

  Through study completion, an average of 18 months

• Sensitivity by smoking history

  Through study completion, an average of 18 months

Study Arms (3)

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

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

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

Interventions

Oral/Throat cancer test DEVICE

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; Oral Squamous Cell Carcinoma (OSCC); Oropharyngeal Squamous Cell Carcinoma (OPSCC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Use of fertility enhancing medications

Sponsors & Collaborators

• Viome: lead

Study Sites (2)

Missouri School of Dentistry & Oral Health

St Louis, Missouri, 63104, United States

RECRUITING

UTHSC

Memphis, Tennessee, 38163, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The Oral/Throat cancer test is intended for the qualitative detection of molecular features (human genes, microbial species and functions) associated with OSCC or OPSCC in saliva samples from adults with a suspicion of cancer. The system consists of the 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.

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Mouth Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Cristina Julian

  Viome

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mory Mehrtash

CONTACT

425-300-6933; studies@viome.com

Momchilo Vuyisich

CONTACT

425-300-6933; studies@viome.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: December 18, 2023
• Study Start: January 27, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 29, 2025

Record last verified: 2025-01

Locations

US (2)