Validity of Viome's Oral/throat Cancer Test

Viome1,000 enrolled

Overview

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.

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

1,000

Conditions

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

Interventions

Oral/Throat cancer testDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Missouri School of Dentistry & Oral Health

St Louis, Missouri, United States

RECRUITING

UTHSC

Memphis, Tennessee, United States

RECRUITING

Outcomes

Primary Outcomes

Sensitivity

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

Time frame: 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

Time frame: 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

Time frame: 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

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

Secondary Outcomes

Sensitivity by care center (primary and secondary)

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

Time frame: 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

Time frame: 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

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

Central Contacts

Mory Mehrtash

CONTACT

425-300-6933 studies@viome.com

Momchilo Vuyisich

CONTACT

425-300-6933 studies@viome.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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

Time frame: 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

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

Sensitivity by oral cancer type (OSCC or OPSCC)

One measure post treatment

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

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

Specificity by care center (primary and secondary)

One measure post treatment

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

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