<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/NCT03020108</url>
  </required_header>
  <id_info>
    <org_study_id>2016/190</org_study_id>
    <nct_id>NCT03020108</nct_id>
  </id_info>
  <brief_title>Serum Caspase 3, Annexin a2 and Soluble Fas Levels and Endometriosis</brief_title>
  <official_title>The Relation Between Serum Caspase 3, Annexin a2 and Soluble Fas Levels and Severity of Endometriosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bakirkoy Dr. Sadi Konuk Research and Training Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bakirkoy Dr. Sadi Konuk Research and Training Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study population will comprise of 90 women age varying between 15-55 years, those are&#xD;
      candidate for laparoscopic surgery due to definition of &gt;4 cm endometrioma or any other&#xD;
      benign ovarian cysts such as mature teratoma or simple serous cysts on ultrasound&#xD;
      examination, chronic pelvic pain, infertility. The blood samples will be drawn for analysis&#xD;
      of serum biomarkers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The participants will be accepted for the study between 1st of August 2016 to 30th June 2017.&#xD;
      2 cc blood samples will be drawn from the antecubital vein for serum analysis of caspase 3,&#xD;
      annexin a2 and soluble fas levels before the operations. The patients will divide into three&#xD;
      groups. The group 1 will comprise of 30 patients with benign ovarian cysts such as mature&#xD;
      teratoma or simple serous cysts on ultrasound examination. The group 2 will comprise of 30&#xD;
      patients with diagnosis of stage 1-2 endometriosis in guidance with the revised American&#xD;
      Society for Reproductive Medicine classification. The group 3 will comprise of 30 patients&#xD;
      with diagnosis of stage 3-4 endometriosis in guidance with the revised American Society for&#xD;
      Reproductive Medicine classification. The blood samples will be kept in -80 C degree after&#xD;
      centrifuge till at the end of the study.The relation between serum caspase 3, annexin a2 and&#xD;
      soluble fas levels and severity of endometriosis will be analysed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2016</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">June 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>To determine endometriosis severity with serum markers</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>To determine rectal involvement with serum markers</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">90</enrollment>
  <condition>Endometriosis</condition>
  <condition>Apoptotic Pathway Deregulation</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <description>The group 1 will comprise of 30 patients with benign ovarian cysts such as mature teratoma or simple serous cysts on ultrasound examination.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <description>The group 2 will comprise of 30 patients with diagnosis of stage 1-2 endometriosis in guidance with the revised American Society for Reproductive Medicine classification.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <description>The group 3 will comprise of 30 patients with diagnosis of stage 3-4 endometriosis in guidance with the revised American Society for Reproductive Medicine classification.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood sample</intervention_name>
    <description>2 cc blood samples will be drawn from antecubital vein</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
    <other_name>Serum caspase 3, annexin a2 and soluble fas levels</other_name>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum analysis&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will comprise of women age varying between 15-55 years, those are&#xD;
        candidate for laparoscopic surgery due to definition of &gt;4 cm endometrioma or any other&#xD;
        benign ovarian cysts such as mature teratoma or simple serous cysts on ultrasound&#xD;
        examination, chronic pelvic pain, infertility.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The women ages varying between 15-55 years, those are candidate for laparoscopic&#xD;
             surgery due to definition of &gt;4 cm endometrioma or any other benign ovarian cysts such&#xD;
             as mature teratoma or simple serous cysts on ultrasound examination, chronic pelvic&#xD;
             pain, infertility.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The women with malignant diseases, chronic bowel disease, other defined cause of&#xD;
             infertility.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cihan Kaya, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bakırkoy Dr. Sadi Konuk Training and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology</name>
      <address>
        <city>Istanbul</city>
        <zip>34250</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/?term=Altered+expression+of+caspases-4+and+-5+during+inflammatory+bowel+disease+and+colorectal+cancer%3A+diagnostic+and+therapeutic+potential</url>
    <description>PUBMED</description>
  </link>
  <reference>
    <citation>Flood B, Oficjalska K, Laukens D, Fay J, O'Grady A, Caiazza F, Heetun Z, Mills KH, Sheahan K, Ryan EJ, Doherty GA, Kay E, Creagh EM. Altered expression of caspases-4 and -5 during inflammatory bowel disease and colorectal cancer: Diagnostic and therapeutic potential. Clin Exp Immunol. 2015 Jul;181(1):39-50. doi: 10.1111/cei.12617. Epub 2015 May 6.</citation>
    <PMID>25943872</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>August 24, 2017</last_update_submitted>
  <last_update_submitted_qc>August 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2017</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>Endometriosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>To be shared with other researchers after all the data is available</ipd_description>
  </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/NCT03020108
org study id: 2016/190
nct id: NCT03020108
lead sponsor: 
has dmc: No
The study population will comprise of 90 women age varying between 15-55 years, those are
      candidate for laparoscopic surgery due to definition of >4 cm endometrioma or any other
      benign ovarian cysts such as mature teratoma or simple serous cysts on ultrasound
      examination, chronic pelvic pain, infertility. The blood samples will be drawn for analysis
      of serum biomarkers.
The participants will be accepted for the study between 1st of August 2016 to 30th June 2017.
      2 cc blood samples will be drawn from the antecubital vein for serum analysis of caspase 3,
      annexin a2 and soluble fas levels before the operations. The patients will divide into three
      groups. The group 1 will comprise of 30 patients with benign ovarian cysts such as mature
      teratoma or simple serous cysts on ultrasound examination. The group 2 will comprise of 30
      patients with diagnosis of stage 1-2 endometriosis in guidance with the revised American
      Society for Reproductive Medicine classification. The group 3 will comprise of 30 patients
      with diagnosis of stage 3-4 endometriosis in guidance with the revised American Society for
      Reproductive Medicine classification. The blood samples will be kept in -80 C degree after
      centrifuge till at the end of the study.The relation between serum caspase 3, annexin a2 and
      soluble fas levels and severity of endometriosis will be analysed.
observational model: Cohort
time perspective: Prospective
measure: To determine endometriosis severity with serum markers
time frame: 1 year
measure: To determine rectal involvement with serum markers
time frame: 1 year
arm group label: Group 1
description: The group 1 will comprise of 30 patients with benign ovarian cysts such as mature teratoma or simple serous cysts on ultrasound examination.
arm group label: Group 2
description: The group 2 will comprise of 30 patients with diagnosis of stage 1-2 endometriosis in guidance with the revised American Society for Reproductive Medicine classification.
arm group label: Group 3
description: The group 3 will comprise of 30 patients with diagnosis of stage 3-4 endometriosis in guidance with the revised American Society for Reproductive Medicine classification.
intervention type: Other
intervention name: Blood sample
description: 2 cc blood samples will be drawn from antecubital vein
arm group label: Group 1
arm group label: Group 2
arm group label: Group 3
other name: Serum caspase 3, annexin a2 and soluble fas levels
Serum analysis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 15 Years
maximum age: 55 Years
healthy volunteers: No
last name: Cihan Kaya, M.D.
role: Principal Investigator
affiliation: Bakırkoy Dr. Sadi Konuk Training and Research Hospital
facility: 
country: Turkey
url: https://www.ncbi.nlm.nih.gov/pubmed/?term=Altered+expression+of+caspases-4+and+-5+during+inflammatory+bowel+disease+and+colorectal+cancer%3A+diagnostic+and+therapeutic+potential
description: PUBMED
citation: Flood B, Oficjalska K, Laukens D, Fay J, O'Grady A, Caiazza F, Heetun Z, Mills KH, Sheahan K, Ryan EJ, Doherty GA, Kay E, Creagh EM. Altered expression of caspases-4 and -5 during inflammatory bowel disease and colorectal cancer: Diagnostic and therapeutic potential. Clin Exp Immunol. 2015 Jul;181(1):39-50. doi: 10.1111/cei.12617. Epub 2015 May 6.
PMID: 25943872
responsible party type: Sponsor
mesh term: Endometriosis
sharing ipd: No
ipd description: To be shared with other researchers after all the data is available