<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/NCT03771651</url>
  </required_header>
  <id_info>
    <org_study_id>9955</org_study_id>
    <nct_id>NCT03771651</nct_id>
  </id_info>
  <brief_title>Short Term Aspirin on the Biologic and Immunologic Changes of the Fallopian Tube</brief_title>
  <official_title>A Surgical Window Pilot Investigation of Short Term Aspirin on the Biologic and Immunologic Changes of the Fallopian Tube</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oklahoma</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Oklahoma</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the impact of low dose aspirin on normal fallopian tube fimbriae in&#xD;
      women who have surgery to have their fallopian tubes removed. Participants will take a low&#xD;
      dose of aspirin for 2 weeks before their surgery. A portion of the removed fallopian tubes&#xD;
      will also be collected for future research and routine pathology purposes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects in this study will receive low dose aspirin for 14 days before undergoing surgery to&#xD;
      remove fallopian tubes removed to determine whether aspirin decreases inflammation in the&#xD;
      fallopian tube. Subjects will also submit blood samples at their initial visit with their&#xD;
      oncologist, at the time of surgery and at the pre-operative visit to measure inflammation&#xD;
      markers and blood counts. A portion of the subject's fallopian tube will be collected for&#xD;
      future research studies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Anticipated">June 2025</completion_date>
  <primary_completion_date type="Anticipated">June 2023</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of subjects who exhibited alterations in the fallopian tube immune microenvironment</measure>
    <time_frame>5 years</time_frame>
    <description>Immuno-cellular assays and percentages of specific immune cells will be compared to control tissue samples.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects who exhibited less carcinogenic potential than control specimens</measure>
    <time_frame>5 years</time_frame>
    <description>Ciliate cells from specimens will be isolated and the number of colony forming units will be compared to control samples.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects who exhibited changes in transcriptome profile compared to control specimens</measure>
    <time_frame>5 years</time_frame>
    <description>Normal fallopian tube fibria will be compared to ovarian cancer specimens to identify novel biomarkers for diagnosis, targets for prevention and better treatment strategies.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Fallopian Tube Cancer</condition>
  <condition>Fallopian Tube Infection</condition>
  <arm_group>
    <arm_group_label>Aspirin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will take 81mg tablets of aspirin daily for 14 days prior to surgery for removal of fallopian tubes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aspirin 81 mg</intervention_name>
    <description>Subjects will take aspirin daily for 14 days leading up to surgery to determine whether it impacts inflammation of fallopian tubes.</description>
    <arm_group_label>Aspirin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women undergoing gynecologic surgery for presumed benign indications that includes the&#xD;
             removal of their fallopian tubes. This may include sterilization procedures,&#xD;
             hysterectomy or partial or full adnexectomy.&#xD;
&#xD;
          -  Eligible women will have fulfilled their childbearing desires&#xD;
&#xD;
          -  Age &gt; 21 Considered low risk for prevalent fallopian tube cancer (not undergoing risk&#xD;
             reducing surgery for a known BRCA mutation or other known hereditary predisposition&#xD;
             syndrome, family history of ovarian cancer in a first degree relative.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Males&#xD;
&#xD;
          -  Women who have presumed or known gynecologic cancer&#xD;
&#xD;
          -  Women less than 21 years of age&#xD;
&#xD;
          -  Women currently on either regular aspirin therapy, non-steroidal anti-inflammatory&#xD;
             drugs (NSAIDS), acetaminophen or chronic steroidal anti-inflammatory medications.&#xD;
&#xD;
          -  Women with known bleeding diathesis or bleeding disorder.&#xD;
&#xD;
          -  Women who do not consent for removal of both fallopian tubes.&#xD;
&#xD;
          -  Women with a history of gastritis or peptic ulcer disease requiring treatment.&#xD;
             (Patients with a history of occasional H1 or H2 blocker use for gastro esophageal&#xD;
             reflux disease are NOT excluded).&#xD;
&#xD;
          -  Women with reported aspirin or NSAID allergy&#xD;
&#xD;
          -  Women with asthma and/or nasal polyps&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laura Holman</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stephenson Cancer Center, University of Oklahoma Health Sciences Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stephenson Cancer Center, University of Oklahoma Health Sciences Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73117</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>December 7, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>May 3, 2023</last_update_submitted>
  <last_update_submitted_qc>May 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 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>Fallopian Tube Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspirin</mesh_term>
  </intervention_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/NCT03771651
org study id: 9955
nct id: NCT03771651
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This study will evaluate the impact of low dose aspirin on normal fallopian tube fimbriae in
      women who have surgery to have their fallopian tubes removed. Participants will take a low
      dose of aspirin for 2 weeks before their surgery. A portion of the removed fallopian tubes
      will also be collected for future research and routine pathology purposes.
Subjects in this study will receive low dose aspirin for 14 days before undergoing surgery to
      remove fallopian tubes removed to determine whether aspirin decreases inflammation in the
      fallopian tube. Subjects will also submit blood samples at their initial visit with their
      oncologist, at the time of surgery and at the pre-operative visit to measure inflammation
      markers and blood counts. A portion of the subject's fallopian tube will be collected for
      future research studies.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of subjects who exhibited alterations in the fallopian tube immune microenvironment
time frame: 5 years
description: Immuno-cellular assays and percentages of specific immune cells will be compared to control tissue samples.
measure: Number of subjects who exhibited less carcinogenic potential than control specimens
time frame: 5 years
description: Ciliate cells from specimens will be isolated and the number of colony forming units will be compared to control samples.
measure: Number of subjects who exhibited changes in transcriptome profile compared to control specimens
time frame: 5 years
description: Normal fallopian tube fibria will be compared to ovarian cancer specimens to identify novel biomarkers for diagnosis, targets for prevention and better treatment strategies.
arm group label: Aspirin
arm group type: Experimental
description: Subjects will take 81mg tablets of aspirin daily for 14 days prior to surgery for removal of fallopian tubes.
intervention type: Drug
intervention name: Aspirin 81 mg
description: Subjects will take aspirin daily for 14 days leading up to surgery to determine whether it impacts inflammation of fallopian tubes.
arm group label: Aspirin
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Laura Holman
role: Principal Investigator
affiliation: Stephenson Cancer Center, University of Oklahoma Health Sciences Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Fallopian Tube Neoplasms
mesh term: Aspirin
sharing ipd: No