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Trial record 1 of 1 for:    NCT03759730
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Role of Microbiome as a Biomarkers in Locoregionally-Advanced Oropharyngeal Squamous Cell Carcinoma (ROMA LA-OPSCC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03759730
Recruitment Status : Completed
First Posted : November 30, 2018
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Study Description
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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 diagnosed with Locoregionally-Advanced Oropharyngeal Squamous Cell Carcinoma (LA-OPSCC) treated with chemoradiotherapy (CRT) at Princess Margaret Cancer Centre.

Condition or disease
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 Design
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Study Type : Observational
Actual Enrollment : 26 participants
Observational Model: Other
Time Perspective: Prospective
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
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  1. 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
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).

Eligibility Criteria
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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
Study Population
Subjects diagnosed with locoregionally-advanced oropharyngeal squamous cell carcinoma
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.

Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Canada, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Lillian Siu, MD Princess Margaret Cancer Centre
Principal Investigator: Anna Spreafico, MD Princess Margaret Cancer Centre
More Information
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03759730    
Other Study ID Numbers: ROMA LA-OPSCC-001
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site