<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/NCT04474184</url>
  </required_header>
  <id_info>
    <org_study_id>19-001140</org_study_id>
    <secondary_id>NCI-2020-04756</secondary_id>
    <nct_id>NCT04474184</nct_id>
  </id_info>
  <brief_title>Development of a New Early Detection Test to Reduce Racial Disparities in Endometrial Cancer (EC) Death Rates</brief_title>
  <official_title>Development of a Novel Early Detection Test to Reduce Racial Disparities in Endometrial Cancer (EC) Mortality</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</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 phase I trial investigates the development of a new early detection test to reduce&#xD;
      racial disparities in endometrial cancer death rates. DNA samples collected from a tampon may&#xD;
      be able to be used to detect endometrial cancer. Studying information from focus groups and&#xD;
      vaginal samples of African American and white women may help researchers develop a less&#xD;
      invasive and painful test to detect endometrial cancer. The purpose of this trial is to&#xD;
      perform a demonstration project of tampon self-collection, assess percentage of samples&#xD;
      returned; total and endometrial derived DNA quantity and quality, preliminarily test&#xD;
      previously validated DNA methylation markers that may discriminate endometrial cancer from&#xD;
      normal endometrium in tampon specimens.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To conduct focus groups to elicit perceptions and knowledge among African American women&#xD;
      (AAW) and white women (WW) concerning abnormal uterine bleeding (AUB)/post-menopausal&#xD;
      bleeding (PMB), endometrial cancer (EC) risk factors, barriers to seeking medical evaluation,&#xD;
      sources of medical information and acceptance and feasibility of tampon self-collection for&#xD;
      laboratory testing.&#xD;
&#xD;
      II. To perform a demonstration project of tampon self-collection from 25 AAW and 25 WW with&#xD;
      AUB/PMB in Jacksonville.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      AIM 1: Participants attend a focus group over 2 hours about endometrial cancer including&#xD;
      knowledge of abnormal uterine bleeding, post-menopausal bleeding, risk factors, sources of&#xD;
      medical information, barriers to seeking gynecologic care, and acceptance of tampon&#xD;
      self-collection for endometrial cancer detection.&#xD;
&#xD;
      AIM 2: Participants receive a tampon kit for collection of vaginal samples.&#xD;
&#xD;
      After completion of study enrollment, participants may be followed up annually for 10 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2020</start_date>
  <completion_date type="Actual">January 25, 2023</completion_date>
  <primary_completion_date type="Actual">January 25, 2023</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Differences in views on endometrial cancer (EC) risk between African American and white women and whether the former would be willing to participate in tampon testing (Aim 1)</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Survey data will be reported as frequencies and proportions to describe the sample. Survey data will also be used to aid in interpretation of the qualitative data as appropriate.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total deoxyribonucleic acid (DNA) (Aim 2)</measure>
    <time_frame>Up to 12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Endometrial DNA (Aim 2)</measure>
    <time_frame>Up to 12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Detection of EC-specific methylation markers (Aim 2)</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Will test samples for top EC-specific DNA methylation markers using methylation-specific polymerase chain reaction and provide descriptive statistics for all measurements (mean, median, standard deviation). Will assess the percentage of samples that yield &gt; 500 ng amplifiable DNA, which suffices for methylation assays.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Endometrial Carcinoma</condition>
  <arm_group>
    <arm_group_label>Aim 1 (focus group)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants attend a focus group over 2 hours about endometrial cancer including knowledge of abnormal uterine bleeding, post-menopausal bleeding, risk factors, sources of medical information, barriers to seeking gynecologic care, and acceptance of tampon self-collection for endometrial cancer detection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aim 2 (vaginal kit)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive a tampon kit for collection of vaginal samples.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Biospecimen Collection</intervention_name>
    <description>Receive vaginal kit for biospecimen collection</description>
    <arm_group_label>Aim 2 (vaginal kit)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Focus Group</intervention_name>
    <description>Attend focus group</description>
    <arm_group_label>Aim 1 (focus group)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Survey Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Aim 1 (focus group)</arm_group_label>
    <arm_group_label>Aim 2 (vaginal kit)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  AIM 1: Self-identified white women (WW) or African American women (AAW) (will record&#xD;
             Hispanic ethnicity)&#xD;
&#xD;
          -  AIM 2: Self-reported history of abnormal uterine bleeding (AUB) or post-menopausal&#xD;
             bleeding (PMB)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  AIM 1: Women who do not identify as WW or AAW&#xD;
&#xD;
          -  AIM 1: Women who are unable to speak and read English&#xD;
&#xD;
          -  AIM 2: Prior hysterectomy&#xD;
&#xD;
          -  AIM 2: Prior pelvic radiation or are unwilling to comply with instructions&#xD;
&#xD;
          -  AIM 2: Pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark E Sherman</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Florida</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224-9980</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>May 19, 2023</last_update_submitted>
  <last_update_submitted_qc>May 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2023</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>Endometrial Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT04474184
org study id: 19-001140
secondary id: NCI-2020-04756
nct id: NCT04474184
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This phase I trial investigates the development of a new early detection test to reduce
      racial disparities in endometrial cancer death rates. DNA samples collected from a tampon may
      be able to be used to detect endometrial cancer. Studying information from focus groups and
      vaginal samples of African American and white women may help researchers develop a less
      invasive and painful test to detect endometrial cancer. The purpose of this trial is to
      perform a demonstration project of tampon self-collection, assess percentage of samples
      returned; total and endometrial derived DNA quantity and quality, preliminarily test
      previously validated DNA methylation markers that may discriminate endometrial cancer from
      normal endometrium in tampon specimens.
PRIMARY OBJECTIVES:

      I. To conduct focus groups to elicit perceptions and knowledge among African American women
      (AAW) and white women (WW) concerning abnormal uterine bleeding (AUB)/post-menopausal
      bleeding (PMB), endometrial cancer (EC) risk factors, barriers to seeking medical evaluation,
      sources of medical information and acceptance and feasibility of tampon self-collection for
      laboratory testing.

      II. To perform a demonstration project of tampon self-collection from 25 AAW and 25 WW with
      AUB/PMB in Jacksonville.

      OUTLINE:

      AIM 1: Participants attend a focus group over 2 hours about endometrial cancer including
      knowledge of abnormal uterine bleeding, post-menopausal bleeding, risk factors, sources of
      medical information, barriers to seeking gynecologic care, and acceptance of tampon
      self-collection for endometrial cancer detection.

      AIM 2: Participants receive a tampon kit for collection of vaginal samples.

      After completion of study enrollment, participants may be followed up annually for 10 years.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Differences in views on endometrial cancer (EC) risk between African American and white women and whether the former would be willing to participate in tampon testing (Aim 1)
time frame: Up to 12 months
description: Survey data will be reported as frequencies and proportions to describe the sample. Survey data will also be used to aid in interpretation of the qualitative data as appropriate.
measure: Total deoxyribonucleic acid (DNA) (Aim 2)
time frame: Up to 12 months
measure: Endometrial DNA (Aim 2)
time frame: Up to 12 months
measure: Detection of EC-specific methylation markers (Aim 2)
time frame: Up to 12 months
description: Will test samples for top EC-specific DNA methylation markers using methylation-specific polymerase chain reaction and provide descriptive statistics for all measurements (mean, median, standard deviation). Will assess the percentage of samples that yield > 500 ng amplifiable DNA, which suffices for methylation assays.
arm group label: Aim 1 (focus group)
arm group type: Experimental
description: Participants attend a focus group over 2 hours about endometrial cancer including knowledge of abnormal uterine bleeding, post-menopausal bleeding, risk factors, sources of medical information, barriers to seeking gynecologic care, and acceptance of tampon self-collection for endometrial cancer detection.
arm group label: Aim 2 (vaginal kit)
arm group type: Experimental
description: Participants receive a tampon kit for collection of vaginal samples.
intervention type: Procedure
intervention name: Biospecimen Collection
description: Receive vaginal kit for biospecimen collection
arm group label: Aim 2 (vaginal kit)
intervention type: Behavioral
intervention name: Focus Group
description: Attend focus group
arm group label: Aim 1 (focus group)
intervention type: Other
intervention name: Survey Administration
description: Ancillary studies
arm group label: Aim 1 (focus group)
arm group label: Aim 2 (vaginal kit)
criteria: 
gender: Female
minimum age: 40 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mark E Sherman
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
responsible party type: Sponsor
mesh term: Endometrial Neoplasms