<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03759730</url>
  </required_header>
  <id_info>
    <org_study_id>ROMA LA-OPSCC-001</org_study_id>
    <nct_id>NCT03759730</nct_id>
  </id_info>
  <brief_title>Role of Microbiome as a Biomarkers in Locoregionally-Advanced Oropharyngeal Squamous Cell Carcinoma</brief_title>
  <acronym>ROMA LA-OPSCC</acronym>
  <official_title>Role of Microbiome as a Biomarkers in Locoregionally-Advanced Oropharyngeal Squamous Cell Carcinoma (ROMA LA-OPSCC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Health Network, Toronto</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a minimal risk feasibility study involving the analysis of patient samples and does&#xD;
      not involve any therapeutic intervention. The study will involve a prospective cohort of up&#xD;
      to 60 patients diagnosed with Locoregionally-Advanced Oropharyngeal Squamous Cell Carcinoma&#xD;
      (LA-OPSCC) treated with chemoradiotherapy (CRT) at Princess Margaret Cancer Centre.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To assess the feasibility of microbiome evaluation in LA-OPSCC patients undergoing CRT using&#xD;
      samples collected by four different methods: Saliva, Oropharyngeal swab over the tumor site&#xD;
      (OP), Stool, and Rectal swab (optional).&#xD;
&#xD;
      This study is investigating the role of oral microbiota as a biomarker in LA-OPSCC. This is a&#xD;
      minimal risk study involving the analysis of patient samples and does not involve therapeutic&#xD;
      intervention. This protocol does not determine eligibility to receive treatment with&#xD;
      concurrent radiotherapy and chemotherapy. It is anticipated that patient accrual will be&#xD;
      completed within 12 months.&#xD;
&#xD;
      The study will involve a prospective cohort of up to 60 patients diagnosed with LA OPSCC&#xD;
      treated with CRT at Princess Margaret Cancer Center.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 5, 2018</start_date>
  <completion_date type="Actual">November 28, 2018</completion_date>
  <primary_completion_date type="Actual">November 28, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of microbiome evaluation in LA-OPSCC patients undergoing CRT using samples collected by four different methods</measure>
    <time_frame>1 year</time_frame>
    <description>To assess the feasibility, the endpoint will be the proportion of analyzable samples.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility of microbiome evaluation in LA-OPSCC patients undergoing CRT using samples collected by four different methods</measure>
    <time_frame>1 year</time_frame>
    <description>To assess the feasibility, the endpoint will be the patient compliance rate with sample collection timeline/procedures.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Evaluation of the relationship between oral and intestinal microbiome composition and diversity in LA-OPSCC patients undergoing CRT.</measure>
    <time_frame>1 year</time_frame>
    <description>To evaluate this relationship, the samples will undergo the following analyses: DNA extraction, 16S rRNA amplification, and Illumina MiSeq Sequencing</description>
  </other_outcome>
  <enrollment type="Actual">26</enrollment>
  <condition>Locoregionally-advanced Oropharyngeal Squamous Cell Carcinoma</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Saliva, oropharyngeal swab over the tumor site, and stool sample are needed to assess the&#xD;
      feasibility of microbiome evaluation in LA-OPSCC patients undergoing chemoradiotherapy (CRT).&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects diagnosed with locoregionally-advanced oropharyngeal squamous cell carcinoma&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed written and voluntary informed consent.&#xD;
&#xD;
          2. Patient must be willing and able to provide collection for saliva, OP swab and stool&#xD;
             specimen analyses at 2 time points. Rectal swab is optional.&#xD;
&#xD;
          3. Age &gt; 18 years, male or female.&#xD;
&#xD;
          4. Patient must be diagnosed with histologically confirmed squamous cell carcinoma of the&#xD;
             oropharynx (soft palate, tonsils, base of tongue).&#xD;
&#xD;
          5. Patients must be eligible for curative-intent concurrent treatment with radiotherapy&#xD;
             and chemotherapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Any condition that, in the opinion of the Investigator, would interfere with patient&#xD;
        safety, or evaluation of the collected specimen and interpretation of study result.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lillian Siu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Princess Margaret Cancer Centre</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Anna Spreafico, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Princess Margaret Cancer Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Princess Margaret Cancer Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>November 23, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>January 30, 2019</last_update_submitted>
  <last_update_submitted_qc>January 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Squamous Cell</mesh_term>
    <mesh_term>Squamous Cell Carcinoma of Head and Neck</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03759730
org study id: ROMA LA-OPSCC-001
nct id: NCT03759730
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Other
time perspective: Prospective
measure: Feasibility of microbiome evaluation in LA-OPSCC patients undergoing CRT using samples collected by four different methods
time frame: 1 year
description: To assess the feasibility, the endpoint will be the proportion of analyzable samples.
measure: Feasibility of microbiome evaluation in LA-OPSCC patients undergoing CRT using samples collected by four different methods
time frame: 1 year
description: To assess the feasibility, the endpoint will be the patient compliance rate with sample collection timeline/procedures.
measure: Evaluation of the relationship between oral and intestinal microbiome composition and diversity in LA-OPSCC patients undergoing CRT.
time frame: 1 year
description: To evaluate this relationship, the samples will undergo the following analyses: DNA extraction, 16S rRNA amplification, and Illumina MiSeq Sequencing
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).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lillian Siu, MD
role: Principal Investigator
affiliation: Princess Margaret Cancer Centre
last name: Anna Spreafico, MD
role: Principal Investigator
affiliation: Princess Margaret Cancer Centre
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Squamous Cell
mesh term: Squamous Cell Carcinoma of Head and Neck
sharing ipd: No