Overview
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.
Description
This is an observational study evaluating the design, safety and efficacy of OralViome Cancer Testing system in the early detection of Oral and Throat Cancers using saliva metatranscriptomic.
A total of 475 participants will be recruited, including 4 different cohorts: 1) cancer free patients, 2) patients with Oral Potentially Malignant Disease (OPMD), 3) patients with Oral Squamous Cell Carcinoma (OSCC), and 4) patients with OroPharyngeal Cancer (OPC). OSCC and OPC participants will be recruited from secondary care facilities, OPMD and cancer free participants will be recruited from primary care facilities.
Participants will complete health questionnaires and collect saliva samples using at home/ in clinic kits provided by Viome. The duration of study participation will be 1 clinic visit for cancer free participants, and up to 1 year for those with OSCC/OPC/OPMD.
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