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Completed
NCT03759730
Role of Microbiome as a Biomarkers in Locoregionally-Advanced Oropharyngeal Squamous Cell Carcinoma
Conditions: Locoregionally-advanced Oropharyngeal Squamous Cell Carcinoma
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 26
Sponsor: University Health Network, Toronto
Location: Princess Margaret Cancer Centre Toronto Ontario
Summary
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT03759730). StuddyBuddy aggregates publicly available trial information.