<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/NCT02997787</url>
  </required_header>
  <id_info>
    <org_study_id>2016/525</org_study_id>
    <nct_id>NCT02997787</nct_id>
  </id_info>
  <brief_title>New Inflammation Markers for Distinguishing Uterine Adenomyosis and Leiomyoma</brief_title>
  <official_title>Neutrophil to Lymphocyte Ratio and Platelet to Lymphocyte Ratio Can Be Useful Markers for Distinguishing Uterine Adenomyosis and Leiomyoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kayseri Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kayseri Education and Research Hospital</source>
  <brief_summary>
    <textblock>
      Both pelvic masses and preoperative diagnosis of them have still continued as an important&#xD;
      investigation subject. It is important to discriminate the diagnoses of leiomyoma and&#xD;
      adenomyosis before operation especially among infertile patients. Neoplasms can alter&#xD;
      systemic or local immune response in their originating area.Neutrophil to lymphocyte ratio&#xD;
      (NLR) and platelet to lymphocyte ratio (PLR) can be readily determined by using of complete&#xD;
      blood counter test (CBC). A high NLR has been shown in systemic inflammation, some&#xD;
      gynecologic and gastrointestinal cancers and some cardiovascular diseases.&#xD;
&#xD;
      The investigators aim to investigate using new inflammation markers, NLR and PLR, whether&#xD;
      they are useful to discriminate between adenomyosis and leiomyoma. As far as is known, there&#xD;
      have been no previous reports about the association among NLR, PLR, adenomyosis and&#xD;
      leiomyoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A retrospective cross-sectional study was conducted at the Kayseri Education and Research&#xD;
      Hospital, Department of Obstetrics and Gynecology, Kayseri, Turkey, between January 2016 and&#xD;
      October 2016.&#xD;
&#xD;
      Approval of the Institutional Review Board of Kayseri Erciyes University the Faculty of&#xD;
      Medicine was obtained in advance (2016/525).&#xD;
&#xD;
      Exclusion criteria were as fallows; diabetes mellitus, metabolic disorder, acute or chronic&#xD;
      infection disease, hypertension, acute coroner artery disease, connective tissue disorder,&#xD;
      vasculitis, inflammatory bowel disease, tobacco and alcohol use, renal failure, hepatitis,&#xD;
      patients using corticosteroid drug and patients underwent blood transfusion within three&#xD;
      months. The investigators reviewed a database of 386 patients who were referred for abnormal&#xD;
      uterine bleeding resistant to medical treatment or detected pelvic mass in postmenopausal and&#xD;
      premenopausal period and underwent hysterectomy in our department. The investigators are&#xD;
      capable of including 196 patients in the present study because of exclusion criteria.&#xD;
&#xD;
      There were three groups in our study. First group called adenomyosis was consisted of&#xD;
      patients who were pathologically diagnosed pure adenomyosis after hysterectomy. Second group&#xD;
      called leiomyoma was consisted of patients who were pathologically diagnosed pure leiomyoma&#xD;
      after hysterectomy. Third group called control group was consisted of healthy patients who&#xD;
      were pathologically diagnosed no neoplasm after hysterectomy.&#xD;
&#xD;
      In order to evaluate serum levels of hemoglobin, leukocytes, neutrophil, lymphocyte, platelet&#xD;
      and CA125, the investigators obtained data analysis measured preoperatively from venous blood&#xD;
      samples of all subjects. The NLR was defined as the absolute neutrophil count divided by the&#xD;
      absolute lymphocyte count and the PLR was defined as the absolute platelet count divided by&#xD;
      the absolute lymphocyte count.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Measured serum inflammatory markers among groups by complete blood count</measure>
    <time_frame>3 months</time_frame>
    <description>Those markers are neutrophil, lymphocyte and platelet count.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Adenomyosis</condition>
  <condition>Leiomyoma</condition>
  <condition>Inflammation</condition>
  <arm_group>
    <arm_group_label>adenomyosis</arm_group_label>
    <description>First group called adenomyosis was consisted of patients who were pathologically diagnosed pure adenomyosis after hysterectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>leiomyoma</arm_group_label>
    <description>Second group called leiomyoma was consisted of patients who were pathologically diagnosed pure leiomyoma after hysterectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <description>Third group called control group was consisted of healthy patients who were pathologically diagnosed no neoplasm after hysterectomy</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        There were three groups in our study. First group called adenomyosis was consisted of&#xD;
        patients who were pathologically diagnosed pure adenomyosis after hysterectomy. Second&#xD;
        group called leiomyoma was consisted of patients who were pathologically diagnosed pure&#xD;
        leiomyoma after hysterectomy. Third group called control group was consisted of healthy&#xD;
        patients who were pathologically diagnosed no neoplasm after hysterectomy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  386 patients who were referred for abnormal uterine bleeding resistant to medical&#xD;
             treatment or detected pelvic mass in postmenopausal and premenopausal period and&#xD;
             underwent hysterectomy in our department were evaluated. However 196 of those patients&#xD;
             were included in the present study because of exclusion criteria.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria were as fallows; diabetes mellitus, metabolic disorder, acute or&#xD;
             chronic infection disease, hypertension, acute coroner artery disease, connective&#xD;
             tissue disorder, vasculitis, inflammatory bowel disease, tobacco and alcohol use,&#xD;
             renal failure, hepatitis, patients using corticosteroid drug and patients underwent&#xD;
             blood transfusion within three months.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yusuf Madendag</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kayseri Education and Research Hospital</affiliation>
  </overall_official>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>December 23, 2016</last_update_submitted>
  <last_update_submitted_qc>December 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 26, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kayseri Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>Yusuf MADENDAG</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <keyword>adenomyosis</keyword>
  <keyword>leiomyoma</keyword>
  <keyword>neutrophil to lymphocyte ratio</keyword>
  <keyword>platelet to lymphocyte ratio</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leiomyoma</mesh_term>
    <mesh_term>Myofibroma</mesh_term>
    <mesh_term>Adenomyosis</mesh_term>
    <mesh_term>Inflammation</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/NCT02997787
org study id: 2016/525
nct id: NCT02997787
lead sponsor: 
Both pelvic masses and preoperative diagnosis of them have still continued as an important
      investigation subject. It is important to discriminate the diagnoses of leiomyoma and
      adenomyosis before operation especially among infertile patients. Neoplasms can alter
      systemic or local immune response in their originating area.Neutrophil to lymphocyte ratio
      (NLR) and platelet to lymphocyte ratio (PLR) can be readily determined by using of complete
      blood counter test (CBC). A high NLR has been shown in systemic inflammation, some
      gynecologic and gastrointestinal cancers and some cardiovascular diseases.

      The investigators aim to investigate using new inflammation markers, NLR and PLR, whether
      they are useful to discriminate between adenomyosis and leiomyoma. As far as is known, there
      have been no previous reports about the association among NLR, PLR, adenomyosis and
      leiomyoma.
A retrospective cross-sectional study was conducted at the Kayseri Education and Research
      Hospital, Department of Obstetrics and Gynecology, Kayseri, Turkey, between January 2016 and
      October 2016.

      Approval of the Institutional Review Board of Kayseri Erciyes University the Faculty of
      Medicine was obtained in advance (2016/525).

      Exclusion criteria were as fallows; diabetes mellitus, metabolic disorder, acute or chronic
      infection disease, hypertension, acute coroner artery disease, connective tissue disorder,
      vasculitis, inflammatory bowel disease, tobacco and alcohol use, renal failure, hepatitis,
      patients using corticosteroid drug and patients underwent blood transfusion within three
      months. The investigators reviewed a database of 386 patients who were referred for abnormal
      uterine bleeding resistant to medical treatment or detected pelvic mass in postmenopausal and
      premenopausal period and underwent hysterectomy in our department. The investigators are
      capable of including 196 patients in the present study because of exclusion criteria.

      There were three groups in our study. First group called adenomyosis was consisted of
      patients who were pathologically diagnosed pure adenomyosis after hysterectomy. Second group
      called leiomyoma was consisted of patients who were pathologically diagnosed pure leiomyoma
      after hysterectomy. Third group called control group was consisted of healthy patients who
      were pathologically diagnosed no neoplasm after hysterectomy.

      In order to evaluate serum levels of hemoglobin, leukocytes, neutrophil, lymphocyte, platelet
      and CA125, the investigators obtained data analysis measured preoperatively from venous blood
      samples of all subjects. The NLR was defined as the absolute neutrophil count divided by the
      absolute lymphocyte count and the PLR was defined as the absolute platelet count divided by
      the absolute lymphocyte count.
observational model: Case-Control
time perspective: Retrospective
measure: Measured serum inflammatory markers among groups by complete blood count
time frame: 3 months
description: Those markers are neutrophil, lymphocyte and platelet count.
arm group label: adenomyosis
description: First group called adenomyosis was consisted of patients who were pathologically diagnosed pure adenomyosis after hysterectomy
arm group label: leiomyoma
description: Second group called leiomyoma was consisted of patients who were pathologically diagnosed pure leiomyoma after hysterectomy
arm group label: control
description: Third group called control group was consisted of healthy patients who were pathologically diagnosed no neoplasm after hysterectomy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 35 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yusuf Madendag
role: Principal Investigator
affiliation: Kayseri Education and Research Hospital
responsible party type: Principal Investigator
investigator affiliation: Kayseri Education and Research Hospital
investigator full name: Yusuf MADENDAG
investigator title: Director
mesh term: Leiomyoma
mesh term: Myofibroma
mesh term: Adenomyosis
mesh term: Inflammation