Role of Microbiome as a Biomarkers in Locoregionally-Advanced Oropharyngeal Squamous Cell Carcinoma
Role of Microbiome as a Biomarkers in Locoregionally-Advanced Oropharyngeal Squamous Cell Carcinoma
This is a minimal risk feasibility study involving the analysis of patient samples and does
 not involve any therapeutic intervention. The study will involve a prospective cohort of up
 to 60 patients diagnosed with Locoregionally-Advanced Oropharyngeal Squamous Cell Carcinoma
 (LA-OPSCC) treated with chemoradiotherapy (CRT) at Princess Margaret Cancer Centre.
To assess the feasibility of microbiome evaluation in LA-OPSCC patients undergoing CRT using
 samples collected by four different methods: Saliva, Oropharyngeal swab over the tumor site
 (OP), Stool, and Rectal swab (optional).

 This study is investigating the role of oral microbiota as a biomarker in LA-OPSCC. This is a
 minimal risk study involving the analysis of patient samples and does not involve therapeutic
 intervention. This protocol does not determine eligibility to receive treatment with
 concurrent radiotherapy and chemotherapy. It is anticipated that patient accrual will be
 completed within 12 months.

 The study will involve a prospective cohort of up to 60 patients diagnosed with LA OPSCC
 treated with CRT at Princess Margaret Cancer Center.
Inclusion Criteria:

 1. Signed written and voluntary informed consent.

 2. Patient must be willing and able to provide collection for saliva, OP swab and stool
 specimen analyses at 2 time points. Rectal swab is optional.

 3. Age > 18 years, male or female.

 4. Patient must be diagnosed with histologically confirmed squamous cell carcinoma of the
 oropharynx (soft palate, tonsils, base of tongue).

 5. Patients must be eligible for curative-intent concurrent treatment with radiotherapy
 and chemotherapy.

 Exclusion Criteria:

 - Any condition that, in the opinion of the Investigator, would interfere with patient
 safety, or evaluation of the collected specimen and interpretation of study result.