Recruiting

Viome

Sponsor:

Viome

Code:

NCT06174428

Conditions

Oral and Throat Cancer

Oropharyngeal Squamous Cell Carcinoma

Oral Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Oral/Throat cancer test

Study Details

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

Study ID

NCT06174428

Start date

Jan 27, 2025

Status verified date

Jan, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Cancer-free

Participants will be recruited following clinical adjudication with self-reported confirmation of no cancer and from primary and secondary care facilities.

Interventions

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.

Primary outcome measure

  • Sensitivity [ Time Frame: Through study completion, an average of 18 months ]
  • Specificity [ Time Frame: Through study completion, an average of 18 months ]
  • Positive Post Test Probability (PPV) [ Time Frame: Through study completion, an average of 18 months ]
  • Negative Post Test Probability (NPV) [ Time Frame: Through study completion, an average of 18 months ]

Central Contacts and Locations

Central contacts

Mory Mehrtash

425-300-6933studies@viome.com

Momchilo Vuyisich

425-300-6933studies@viome.com

Locations

Missouri School of Dentistry & Oral Health

Recruiting

St. Louis, Missouri, United States, 63104

Contacts

Adepitan Owosho

314-833-2729adepitanowosho@atsu.edu

UTHSC

Recruiting

Memphis, Tennessee, United States, 38163

Contacts

Yanhui Zhang, Ph.D.

901.448.3751yzhang36@uthsc.edu

More Information

Sponsor

Viome

Last update posted

Jan 29, 2025

Last verified

Jan, 2025

Keywords

  • OSCC
  • OPSCC
  • Oral Cancer
  • Throat cancer
  • Oral and Throat cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Viome on 2025-01-29.