Status:
COMPLETED
Role of Microbiome as a Biomarkers in Locoregionally-Advanced Oropharyngeal Squamous Cell Carcinoma
Lead Sponsor:
University Health Network, Toronto
Conditions:
Locoregionally-advanced Oropharyngeal Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Brief 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 d...
Detailed Description
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, an...
Eligibility Criteria
Inclusion
- Signed written and voluntary informed consent.
- 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.
- Age \> 18 years, male or female.
- Patient must be diagnosed with histologically confirmed squamous cell carcinoma of the oropharynx (soft palate, tonsils, base of tongue).
- Patients must be eligible for curative-intent concurrent treatment with radiotherapy and chemotherapy.
Exclusion
- \- 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.
Key Trial Info
Start Date :
January 5 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 28 2018
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT03759730
Start Date
January 5 2018
End Date
November 28 2018
Last Update
January 31 2019
Active Locations (1)
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1
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9