<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/NCT02261311</url>
  </required_header>
  <id_info>
    <org_study_id>20130232-01H</org_study_id>
    <nct_id>NCT02261311</nct_id>
  </id_info>
  <brief_title>An Innovation During the Surgical Wait; Evaluation of the Opportunity for Intervention</brief_title>
  <acronym>RADSII</acronym>
  <official_title>An Innovation During the Surgical Wait; Evaluation of the Opportunity for Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ottawa Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ottawa Hospital Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators will compare the differences in the scores between the baseline&#xD;
      questionnaire (at diagnosis) and the second questionnaire (at treatment) in the RADS II&#xD;
      patients that enrolled in pre-treatment trials versus those that don't.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>March 2017</start_date>
  <completion_date type="Anticipated">October 2017</completion_date>
  <primary_completion_date type="Anticipated">October 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of life</measure>
    <time_frame>up to 6 weeks</time_frame>
    <description>To determine if there are improvements in the measurements of anxiety through quality of life questionnaires completed at 2 different time points when participating in a window of opportunity trial verses not participating in a window of opportunity trial.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Quality of Life, tissue collection</arm_group_label>
    <description>All participants will complete the GAD-7 and Cancer Locus of Control Scale - Course of Illness Subscale questionnaires and additional tissue will be collected at the time of the diagnostic biopsy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality of Life</intervention_name>
    <description>All participants recruited will complete a questionnaire prior to their breast biopsy and then again approximately one week before their surgery. The questionnaire is focused on the level of anxiety patients experience during the wait time between diagnosis and surgery. Additional tissue will be collected at the time of the diagnostic biopsy.</description>
    <arm_group_label>Quality of Life, tissue collection</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Additional tissue samples will be collected at the time of initial biopsy. The samples will&#xD;
      be stored for neoadjuvant studies that the patient may choose to participate in during the&#xD;
      wait time between diaganosis and surgery.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Women with BIRADS 4/5 on initial mammogram.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt;18 years of age&#xD;
&#xD;
          -  Diagnosis of BI-RADS 4 and 5 (highly suspicious for carcinoma) on an initial imaging&#xD;
&#xD;
          -  &gt;2cm area of disease&#xD;
&#xD;
          -  Provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous neo-adjuvant therapy&#xD;
&#xD;
          -  Patients with recurrent disease&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Angel Arnaout, Surgeon</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Ottawa Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Angel Arnaout, Surgeon</last_name>
    <phone>613-737-7700</phone>
    <phone_ext>79071</phone_ext>
    <email>aarnaout@toh.on.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>The Ottawa Hospital</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1Y 4E9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <contact>
      <last_name>Angel Arnaout, Surgeon</last_name>
      <phone>613-737-7700</phone>
      <phone_ext>79071</phone_ext>
      <email>aarnaout@toh.on.ca</email>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>September 15, 2016</last_update_submitted>
  <last_update_submitted_qc>September 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 16, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breast</keyword>
  <!-- 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/NCT02261311
org study id: 20130232-01H
nct id: NCT02261311
lead sponsor: 
has dmc: No
The investigators will compare the differences in the scores between the baseline
      questionnaire (at diagnosis) and the second questionnaire (at treatment) in the RADS II
      patients that enrolled in pre-treatment trials versus those that don't.
observational model: Cohort
time perspective: Prospective
measure: Quality of life
time frame: up to 6 weeks
description: To determine if there are improvements in the measurements of anxiety through quality of life questionnaires completed at 2 different time points when participating in a window of opportunity trial verses not participating in a window of opportunity trial.
arm group label: Quality of Life, tissue collection
description: All participants will complete the GAD-7 and Cancer Locus of Control Scale - Course of Illness Subscale questionnaires and additional tissue will be collected at the time of the diagnostic biopsy.
intervention type: Other
intervention name: Quality of Life
description: All participants recruited will complete a questionnaire prior to their breast biopsy and then again approximately one week before their surgery. The questionnaire is focused on the level of anxiety patients experience during the wait time between diagnosis and surgery. Additional tissue will be collected at the time of the diagnostic biopsy.
arm group label: Quality of Life, tissue collection
Additional tissue samples will be collected at the time of initial biopsy. The samples will
      be stored for neoadjuvant studies that the patient may choose to participate in during the
      wait time between diaganosis and surgery.
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Angel Arnaout, Surgeon
role: Principal Investigator
affiliation: The Ottawa Hospital
last name: Angel Arnaout, Surgeon
phone: 613-737-7700
phone ext: 79071
email: aarnaout@toh.on.ca
facility: 
contact: 
country: Canada
responsible party type: Sponsor