Oral Squamous Cell Carcinoma Clinical Trial
Official title:
Detection of Oral and Throat Cancers Using Saliva Metatranscriptomic Analysis
NCT number | NCT05451303 |
Other study ID # | V300 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 27, 2022 |
Est. completion date | December 2025 |
Verified date | December 2023 |
Source | Viome |
Contact | Mory Mehrtash, MSc |
Phone | 425-300-6933 |
studies[@]viome.com | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
To evaluate the design, safety and efficacy of OralViome Cancer Testing system in the early detection of Oral and Throat Cancers using saliva metatranscriptomic analysis. This study will recruit only at existing clinical sites and will NOT use any additional clinical sites.
Status | Recruiting |
Enrollment | 475 |
Est. completion date | December 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria for participants in OSCC or OPC cohorts - Participants must be diagnosed with oral squamous cell carcinoma (OSCC) and/or OroPharyngeal cancer (OPC) - Aged 18 years or older - 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 Exclusion Criteria for participants in OSCC or OPC cohorts - Pregnancy - Use of fertility enhancing medications - Active infection Inclusion Criteria for participants in OPMD cohorts - Any Oral Premalignant Disorder (OPMD) - Dysplasia - Hyperplasia - Leukoplakia - Erythroplasia - Lichenoid lesions - Actinic Keratosis - Lichenoid reaction - Aphthous ulcer/ Canker Sores - Gingival enlargement (side effect) - Lichen planus - Keratosis - Inflammatory reaction - Cheek bites - Aged =50 years OR aged 18 years or older with a history of tobacco use (see above) - 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 Exclusion Criteria for participants in OPMD cohorts - Pregnancy - Use of fertility enhancing medications - Active infection Inclusion Criteria for participants in cancer-free cohorts - Aged = 50 years OR aged 18 years or older with a history of tobacco use - 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 Exclusion criteria for participants in cancer-free cohorts - Pregnancy - Use of fertility enhancing medications - Active infection |
Country | Name | City | State |
---|---|---|---|
United States | NYMC | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Viome | New York Medical College |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary endpoint will be the detection or not of OSCC or OPC | The test results will be compared against the definitive diagnosis by the physician. | 1 year |
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