Validity of Viome's Oral/Throat Cancer Test

Oral Squamous Cell Carcinoma Clinical Trial

Official title:

Validity of Viome's Oral/Throat Cancer Test Among Patients With a Suspicion of Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06174428
• Other study ID #: V303
• Status: Not yet recruiting
• Start date: September 2024
• Est. completion date: December 2026

Study information

• Verified date: April 2024
• Source: Viome
• Contact: Mory Mehrtash
• Phone: 425-300-6933
• Email: studies[@]viome.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: December 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

• Active infection (except for HPV)

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Oral Squamous Cell Carcinoma
• Oropharyngeal Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

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 from follow-up diagnosis and treatment. The device is not intended for a definitive diagnosis.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Viome

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity	Oral/Throat cancer test's ability to designate an individual with disease as positive	Through study completion, an average of 18 months
Primary	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
Primary	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
Primary	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	Sensitivity by care center (primary and secondary)	Oral/Throat cancer test's ability to designate an individual with disease as positive	Through study completion, an average of 18 months
Secondary	Sensitivity by age	Oral/Throat cancer test's ability to designate an individual with disease as positive	Through study completion, an average of 18 months
Secondary	Sensitivity by sex	Oral/Throat cancer test's ability to designate an individual with disease as positive	Through study completion, an average of 18 months
Secondary	Sensitivity by race	Oral/Throat cancer test's ability to designate an individual with disease as positive	Through study completion, an average of 18 months
Secondary	Sensitivity by smoking history	Oral/Throat cancer test's ability to designate an individual with disease as positive	Through study completion, an average of 18 months
Secondary	Sensitivity by oral cancer type (OSCC or OPSCC)	One measure post treatment	Through study completion, an average of 18 months
Secondary	Sensitivity by disease stage (I, II, III, and IV)	Oral/Throat cancer test's ability to designate an individual with disease as positive	Through study completion, an average of 18 months
Secondary	Sensitivity by metastasis	Oral/Throat cancer test's ability to designate an individual with disease as positive	Through study completion, an average of 18 months
Secondary	Sensitivity by HPV status	Oral/Throat cancer test's ability to designate an individual with disease as positive	Through study completion, an average of 18 months
Secondary	Sensitivity by recurrent cancer	Oral/Throat cancer test's ability to designate an individual with disease as positive	Through study completion, an average of 18 months
Secondary	Specificity by care center (primary and secondary)	One measure post treatment	Through study completion, an average of 18 months
Secondary	Specificity by age	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
Secondary	Specificity by sex	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
Secondary	Specificity by race	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
Secondary	Specificity by smoking history	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
Secondary	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	Through study completion, an average of 18 months
Secondary	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	Through study completion, an average of 18 months
Secondary	Specificity by metastasis	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
Secondary	Specificity by HPV status	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
Secondary	Specificity by recurrent cancer	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