Validity of Viome's Oral/throat Cancer Test
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oral/Throat cancer test.
- Who it may be relevant to
- Registry conditions: Oral and Throat Cancer, Oropharyngeal Squamous Cell Carcinoma, Oral Squamous Cell Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Validity of Viome's Oral/throat Cancer Test Among Patients with a Suspicion of Cancer
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.
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.
Interventions
- 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 fro
Primary outcome measures
- 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]
Secondary outcome measures (12)
- Sensitivity by care center (primary and secondary) [Time frame: Through study completion, an average of 18 months]
- Sensitivity by age [Time frame: Through study completion, an average of 18 months]
- Sensitivity by sex [Time frame: Through study completion, an average of 18 months]
- Sensitivity by race [Time frame: Through study completion, an average of 18 months]
- Sensitivity by smoking history [Time frame: Through study completion, an average of 18 months]
- Sensitivity by oral cancer type (OSCC or OPSCC) [Time frame: Through study completion, an average of 18 months]
- Sensitivity by disease stage (I, II, III, and IV) [Time frame: Through study completion, an average of 18 months]
- Sensitivity by metastasis [Time frame: Through study completion, an average of 18 months]
- Sensitivity by HPV status [Time frame: Through study completion, an average of 18 months]
- Sensitivity by recurrent cancer [Time frame: Through study completion, an average of 18 months]
- Specificity by care center (primary and secondary) [Time frame: Through study completion, an average of 18 months]
- Specificity by age [Time frame: Through study completion, an average of 18 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- Missouri School of Dentistry & Oral Health — St Louis
- UTHSC — Memphis
Identifiers
NCT: NCT06174428 · V303