Clinical trial NCT06174428: Validity of Viome's Oral/throat Cancer Test
Official title: Validity of Viome's Oral/throat Cancer Test Among Patients with a Suspicion of Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Oral and Throat Cancer
Oropharyngeal Squamous Cell Carcinoma
Oral Squamous Cell Carcinoma
Keywords: OSCC
OPSCC
Oral Cancer
Throat cancer
Oral and Throat cancer
Lead sponsor: Viome
Sponsor class: INDUSTRY
First posted: 2023-12-18
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will comprise patients who attend (1) a primary care center (typically dentist offices) and are identified with a suspicion of cancer based on a clinical presentation or (2) a secondary care center (typically hospitals) following the finding of a suspicious lesion or symptom. Secondary care centers include clinical sites where specialists such as oncologists or oral and maxillofacial surgeons (also called head and neck surgeons) perform visual and tactile oral examinations and biopsies to detect oral cancer. They are also known as ear, nose, and throat (ENT) doctors or otolaryngologists.

Women or minorities are not excluded from this study. In order to calculate an estimated number of samples in each demographic category we performed stratified random sampling. We used the SEER Program to calculate oral and throat cancer prevalence for each of the demographic categories.

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.

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.

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

Primary outcomes:
measure: Sensitivity
timeFrame: Through study completion, an average of 18 months
measure: Specificity
timeFrame: Through study completion, an average of 18 months
measure: Positive Post Test Probability (PPV)
timeFrame: Through study completion, an average of 18 months
measure: Negative Post Test Probability (NPV)
timeFrame: Through study completion, an average of 18 months
Secondary outcomes:
measure: Sensitivity by care center (primary and secondary)
timeFrame: Through study completion, an average of 18 months
measure: Sensitivity by age
timeFrame: Through study completion, an average of 18 months
measure: Sensitivity by sex
timeFrame: Through study completion, an average of 18 months
measure: Sensitivity by race
timeFrame: Through study completion, an average of 18 months
measure: Sensitivity by smoking history
timeFrame: Through study completion, an average of 18 months
measure: Sensitivity by oral cancer type (OSCC or OPSCC)
timeFrame: Through study completion, an average of 18 months
measure: Sensitivity by disease stage (I, II, III, and IV)
timeFrame: Through study completion, an average of 18 months
measure: Sensitivity by metastasis
timeFrame: Through study completion, an average of 18 months
measure: Sensitivity by HPV status
timeFrame: Through study completion, an average of 18 months
measure: Sensitivity by recurrent cancer
timeFrame: Through study completion, an average of 18 months
measure: Specificity by care center (primary and secondary)
timeFrame: Through study completion, an average of 18 months
measure: Specificity by age
timeFrame: Through study completion, an average of 18 months
measure: Specificity by sex
timeFrame: Through study completion, an average of 18 months
measure: Specificity by race
timeFrame: Through study completion, an average of 18 months
measure: Specificity by smoking history
timeFrame: Through study completion, an average of 18 months
measure: Specificity by oral cancer type (OSCC or OPSCC)
timeFrame: Through study completion, an average of 18 months
measure: Specificity by disease stage (I, II, III, and IV)
timeFrame: Through study completion, an average of 18 months
measure: Specificity by metastasis
timeFrame: Through study completion, an average of 18 months
measure: Specificity by HPV status
timeFrame: Through study completion, an average of 18 months
measure: Specificity by recurrent cancer
timeFrame: Through study completion, an average of 18 months
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Missouri School of Dentistry & Oral Health
state: Missouri
city: Memphis
country: United States
facility: UTHSC
state: Tennessee
Study officials:
affiliation: Viome
name: Cristina Julian
role: PRINCIPAL_INVESTIGATOR
References: