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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of microbiome evaluation in LA-OPSCC patients undergoing CRT using samples collected by four different methods | To assess the feasibility, the endpoint will be the proportion of analyzable samples. | 1 year |
| Feasibility of microbiome evaluation in LA-OPSCC patients undergoing CRT using samples collected by four different methods | To assess the feasibility, the endpoint will be the patient compliance rate with sample collection timeline/procedures. | 1 year |
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the relationship between oral and intestinal microbiome composition and diversity in LA-OPSCC patients undergoing CRT. | To evaluate this relationship, the samples will undergo the following analyses: DNA extraction, 16S rRNA amplification, and Illumina MiSeq Sequencing | 1 year |
Inclusion Criteria:
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.
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Subjects diagnosed with locoregionally-advanced oropharyngeal squamous cell carcinoma
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| Name | Affiliation | Role |
|---|---|---|
| Lillian Siu, MD | Princess Margaret Cancer Centre | Principal Investigator |
| Anna Spreafico, MD | Princess Margaret Cancer Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
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Saliva, oropharyngeal swab over the tumor site, and stool sample are needed to assess the feasibility of microbiome evaluation in LA-OPSCC patients undergoing chemoradiotherapy (CRT).