<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/NCT03283345</url>
  </required_header>
  <id_info>
    <org_study_id>2008/69</org_study_id>
    <nct_id>NCT03283345</nct_id>
  </id_info>
  <brief_title>Effect of Menstrual Cycle on Traumatic Systemic Response</brief_title>
  <official_title>ASSESSMENT OF SYSTEMIC RESPONSES TO TRAUMA IN DIFFERENT PHASES OF THE MENSTRUAL CYCLE: IN PATIENTS UNDERWENT MODIFIED RADICAL MASTECTOMY A Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kocaeli University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kocaeli University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      It is aimed to evaluate pathophysiology of systemic responses to trauma via using interleukin&#xD;
      (IL) -1 and IL-6 levels and determining timing of surgery through phases of menstrual cycle.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      89 female breast cancer patient who underwent modified radical mastectomy included into&#xD;
      study. Menstrual history and hormone levels were used to determine menstrual phase: luteal,&#xD;
      follicular, and other. IL-1β and IL-6 levels, which are related to severeness of&#xD;
      inflammation, were measured one day before and one day after surgery. Those are statistically&#xD;
      analysed to show effect of timing of breast surgery on responses to trauma in postmenopausal&#xD;
      and premenopausal women during different phases of their menstrual cycles&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">June 2008</start_date>
  <completion_date type="Anticipated">November 2018</completion_date>
  <primary_completion_date type="Anticipated">November 2018</primary_completion_date>
  <phase>N/A</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>IL-1 and IL-6 levels</measure>
    <time_frame>5 month</time_frame>
    <description>evaluate pathophysiology of systemic responses to trauma via using IL-1 and IL-6 levels.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">89</enrollment>
  <condition>Systemic Inflammatory Response Syndrome</condition>
  <arm_group>
    <arm_group_label>postmenopausal women</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>postmenopausal female breast cancer patients who underwent modified radical mastectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>premenopausal women</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>premenopausal female breast cancer patients who underwent modified radical mastectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>modified radical mastectomy</intervention_name>
    <description>systemic responses to trauma are compared with evaluating inflammatory cytokine levels between premenopausal and postmenopausal patient groups with different estrogen levels who underwent modified radical mastectomy.</description>
    <arm_group_label>postmenopausal women</arm_group_label>
    <arm_group_label>premenopausal women</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  female patients&#xD;
&#xD;
          -  who underwent modified radical mastectomy for breast cancer&#xD;
&#xD;
          -  who signed informed consent forms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  For premenopausal patients taking oral contraceptives&#xD;
&#xD;
          -  for postmenopausal patients taking hormone replacement therapy.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cantürk</last_name>
    <role>Study Director</role>
    <affiliation>Kocaeli University</affiliation>
  </overall_official>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>September 15, 2017</last_update_submitted>
  <last_update_submitted_qc>September 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kocaeli University</investigator_affiliation>
    <investigator_full_name>Hayal Uzelli Şimşek</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>breast cancer</keyword>
  <keyword>menstrual cycle</keyword>
  <keyword>breast surgery</keyword>
  <keyword>systemic responses to trauma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Systemic Inflammatory Response Syndrome</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/NCT03283345
org study id: 2008/69
nct id: NCT03283345
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
It is aimed to evaluate pathophysiology of systemic responses to trauma via using interleukin
      (IL) -1 and IL-6 levels and determining timing of surgery through phases of menstrual cycle.
89 female breast cancer patient who underwent modified radical mastectomy included into
      study. Menstrual history and hormone levels were used to determine menstrual phase: luteal,
      follicular, and other. IL-1β and IL-6 levels, which are related to severeness of
      inflammation, were measured one day before and one day after surgery. Those are statistically
      analysed to show effect of timing of breast surgery on responses to trauma in postmenopausal
      and premenopausal women during different phases of their menstrual cycles
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: IL-1 and IL-6 levels
time frame: 5 month
description: evaluate pathophysiology of systemic responses to trauma via using IL-1 and IL-6 levels.
arm group label: postmenopausal women
arm group type: Active Comparator
description: postmenopausal female breast cancer patients who underwent modified radical mastectomy
arm group label: premenopausal women
arm group type: Active Comparator
description: premenopausal female breast cancer patients who underwent modified radical mastectomy
intervention type: Procedure
intervention name: modified radical mastectomy
description: systemic responses to trauma are compared with evaluating inflammatory cytokine levels between premenopausal and postmenopausal patient groups with different estrogen levels who underwent modified radical mastectomy.
arm group label: postmenopausal women
arm group label: premenopausal women
criteria: 
gender: Female
gender based: Yes
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Cantürk
role: Study Director
affiliation: Kocaeli University
responsible party type: Principal Investigator
investigator affiliation: Kocaeli University
investigator full name: Hayal Uzelli Şimşek
investigator title: Principal investigator
mesh term: Systemic Inflammatory Response Syndrome