Role of Microbiome as a Biomarkers in Locoregionally-Advanced Oropharyngeal Squamous Cell Carcinoma (ROMA LA-OPSCC)

Role of Microbiome as a Biomarkers in Locoregionally-Advanced Oropharyngeal Squamous Cell Carcinoma (ROMA LA-OPSCC)

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.

Study Overview

• Status: Completed
• Conditions: Locoregionally-advanced Oropharyngeal Squamous Cell Carcinoma

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, 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
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects diagnosed with locoregionally-advanced oropharyngeal squamous cell carcinoma

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Anna Spreafico, MD, Princess Margaret Cancer Centre

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2018
• Primary Completion (Actual): November 28, 2018
• Study Completion (Actual): November 28, 2018

Study Registration Dates

• First Submitted: November 23, 2018
• First Submitted That Met QC Criteria: November 28, 2018
• First Posted (Actual): November 30, 2018

Study Record Updates

• Last Update Posted (Actual): January 31, 2019
• Last Update Submitted That Met QC Criteria: January 30, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
• Other Study ID Numbers: ROMA LA-OPSCC-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No