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NCT Number: NCT06174428

Validity of Viome's Oral/throat Cancer Test

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.

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Key information

Conditions

Oral and Throat Cancer Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Oral Squamous Cell Carcinoma Oropharyngeal Squamous Cell Carcinoma Squamous Cell Carcinoma of Head and Neck Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Missouri School of Dentistry & Oral Health, St Louis, Missouri, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Sensitivity

    Time frame: Through study completion, an average of 18 months

    Oral/Throat cancer test's ability to designate an individual with disease as positive

  2. Specificity

    Time frame: Through study completion, an average of 18 months

    Oral/Throat cancer test's ability to designate an individual who does not have a disease as negative

  3. Positive Post Test Probability (PPV)

    Time frame: Through study completion, an average of 18 months

    The probability of having the target condition if the test falls out positive

  4. Negative Post Test Probability (NPV)

    Time frame: Through study completion, an average of 18 months

    The probability of having the target condition if the test falls out negative

Secondary outcomes

  1. Sensitivity by care center (primary and secondary)

    Time frame: Through study completion, an average of 18 months

    Oral/Throat cancer test's ability to designate an individual with disease as positive

  2. Sensitivity by age

    Time frame: Through study completion, an average of 18 months

    Oral/Throat cancer test's ability to designate an individual with disease as positive

  3. Sensitivity by sex

    Time frame: Through study completion, an average of 18 months

    Oral/Throat cancer test's ability to designate an individual with disease as positive

  4. Sensitivity by race

    Time frame: Through study completion, an average of 18 months

    Oral/Throat cancer test's ability to designate an individual with disease as positive

  5. Sensitivity by smoking history

    Time frame: Through study completion, an average of 18 months

    Oral/Throat cancer test's ability to designate an individual with disease as positive

  6. Sensitivity by oral cancer type (OSCC or OPSCC)

    Time frame: Through study completion, an average of 18 months

    One measure post treatment

  7. Sensitivity by disease stage (I, II, III, and IV)

    Time frame: Through study completion, an average of 18 months

    Oral/Throat cancer test's ability to designate an individual with disease as positive

  8. Sensitivity by metastasis

    Time frame: Through study completion, an average of 18 months

    Oral/Throat cancer test's ability to designate an individual with disease as positive

  9. Sensitivity by HPV status

    Time frame: Through study completion, an average of 18 months

    Oral/Throat cancer test's ability to designate an individual with disease as positive

  10. Sensitivity by recurrent cancer

    Time frame: Through study completion, an average of 18 months

    Oral/Throat cancer test's ability to designate an individual with disease as positive

  11. Specificity by care center (primary and secondary)

    Time frame: Through study completion, an average of 18 months

    One measure post treatment

  12. Specificity by age

    Time frame: Through study completion, an average of 18 months

    Oral/Throat cancer test's ability to designate an individual who does not have a disease as negative

  13. Specificity by sex

    Time frame: Through study completion, an average of 18 months

    Oral/Throat cancer test's ability to designate an individual who does not have a disease as negative

  14. Specificity by race

    Time frame: Through study completion, an average of 18 months

    Oral/Throat cancer test's ability to designate an individual who does not have a disease as negative

  15. Specificity by smoking history

    Time frame: Through study completion, an average of 18 months

    Oral/Throat cancer test's ability to designate an individual who does not have a disease as negative

  16. Specificity by oral cancer type (OSCC or OPSCC)

    Time frame: Through study completion, an average of 18 months

    Oral/Throat cancer test's ability to designate an individual who does not have a disease as negative

  17. Specificity by disease stage (I, II, III, and IV)

    Time frame: Through study completion, an average of 18 months

    Oral/Throat cancer test's ability to designate an individual who does not have a disease as negative

  18. Specificity by metastasis

    Time frame: Through study completion, an average of 18 months

    Oral/Throat cancer test's ability to designate an individual who does not have a disease as negative

  19. Specificity by HPV status

    Time frame: Through study completion, an average of 18 months

    Oral/Throat cancer test's ability to designate an individual who does not have a disease as negative

  20. Specificity by recurrent cancer

    Time frame: Through study completion, an average of 18 months

    Oral/Throat cancer test's ability to designate an individual who does not have a disease as negative

Study contacts

Contact information is provided by the study sponsor or research team.

Momchilo Vuyisich

CONTACT

[email protected]

425-300-6933

Mory Mehrtash

CONTACT

[email protected]

425-300-6933

Sponsors and collaborators

Lead sponsor

Viome

Industry

Registry information

Official study title

Validity of Viome's Oral/throat Cancer Test Among Patients with a Suspicion of Cancer

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 18, 2023
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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