Role of Microbiome as a Biomarkers in Locoregionally-Advanced Oropharyngeal Squamous Cell Carcinoma (ROMA LA-OPSCC)
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|ClinicalTrials.gov Identifier: NCT03759730|
Recruitment Status : Completed
First Posted : November 30, 2018
Last Update Posted : January 31, 2019
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|Condition or disease|
|Locoregionally-advanced Oropharyngeal Squamous Cell Carcinoma|
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.
|Study Type :||Observational|
|Actual Enrollment :||26 participants|
|Official Title:||Role of Microbiome as a Biomarkers in Locoregionally-Advanced Oropharyngeal Squamous Cell Carcinoma (ROMA LA-OPSCC)|
|Actual Study Start Date :||January 5, 2018|
|Actual Primary Completion Date :||November 28, 2018|
|Actual Study Completion Date :||November 28, 2018|
- Feasibility of microbiome evaluation in LA-OPSCC patients undergoing CRT using samples collected by four different methods [ Time Frame: 1 year ]To assess the feasibility, the endpoint will be the proportion of analyzable samples.
- Feasibility of microbiome evaluation in LA-OPSCC patients undergoing CRT using samples collected by four different methods [ Time Frame: 1 year ]To assess the feasibility, the endpoint will be the patient compliance rate with sample collection timeline/procedures.
- Evaluation of the relationship between oral and intestinal microbiome composition and diversity in LA-OPSCC patients undergoing CRT. [ Time Frame: 1 year ]To evaluate this relationship, the samples will undergo the following analyses: DNA extraction, 16S rRNA amplification, and Illumina MiSeq Sequencing
Biospecimen Retention: Samples With DNA
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03759730
|Princess Margaret Cancer Centre|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Lillian Siu, MD||Princess Margaret Cancer Centre|
|Principal Investigator:||Anna Spreafico, MD||Princess Margaret Cancer Centre|
|Responsible Party:||University Health Network, Toronto|
|Other Study ID Numbers:||
|First Posted:||November 30, 2018 Key Record Dates|
|Last Update Posted:||January 31, 2019|
|Last Verified:||January 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site