<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/NCT03765905</url>
  </required_header>
  <id_info>
    <org_study_id>Karadeniz Technical University</org_study_id>
    <nct_id>NCT03765905</nct_id>
  </id_info>
  <brief_title>Evaluation of Serum Scube-1 Scube-2 and Scube-3 Levels in Patients With Polikistik Over Syndrome ,</brief_title>
  <official_title>Evaluation of Serum Scube-1 Scube-2 and Scube-3 Levels in Patients With Polikistik Over Syndrome ,</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karadeniz Technical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karadeniz Technical 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>
      The aim of this study is to investigate serum SCUBE-1 and SCUBE-3 levels in PCOS and non-PCOS&#xD;
      cases compared with non-PCOS healthy controls with similar age and body mass index&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study was to investigate serum SCUBE1 and SCUBE3 levels in PCOS and non-PCOS&#xD;
      cases compared with non-PCOS healthy controls with similar age and body mass index.&#xD;
&#xD;
      This will be a prospective clinical laboratory study,It will include women with PCOS&#xD;
      diagnosis (according to the 2003 Rotherdam criteria). 40 cases of reproductive age will be&#xD;
      included in the study group, which will be included in the survey after being approved for&#xD;
      participation in the survey from field trials. Forty patients who will not have any&#xD;
      complaints between the ages of 18-35 who will apply to the gynecology policlinic as a control&#xD;
      group but who had no PCOS o rany other systemic problems and will be similar in terms of age&#xD;
      group and body mass index will be included in the study after being approved for&#xD;
      participation in the study. From the study and control group, 5 mL of blood will be taken&#xD;
      from the untreated biochemical tube for serum SCUBE1 SCUBE2 SCUBE3. The blood samples will be&#xD;
      centrifuged at 1000 g for 10 minutes and the serum fraction will be obtained and the serum&#xD;
      will be stored at -80 ° C to be stored until the day of the tube operation. Serum SCUBE1,&#xD;
      SCUBE2 SCUBE3 levels will be measured using ELISA kits. ,&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2017</start_date>
  <completion_date type="Actual">February 1, 2018</completion_date>
  <primary_completion_date type="Actual">February 1, 2018</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Serum SCUBE 1</measure>
    <time_frame>01.01.2017-31.12.2017</time_frame>
    <description>Serum scube1 in microgram</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum SCUBE 2</measure>
    <time_frame>01.01.2017-31.12.2017</time_frame>
    <description>Serum scube2 in microgram</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum SCUBE 3</measure>
    <time_frame>01.01.2017-31.12.2017</time_frame>
    <description>Serum scube3 in microgram</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">80</enrollment>
  <condition>Polycystic Ovary Syndrome</condition>
  <arm_group>
    <arm_group_label>PCOS diagnosis area</arm_group_label>
    <description>The study group consisted of 40 reproductive age women between 18th and 35th years old women who were PCOS diagnosis (according to the 2003 Rotherdam criteria)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PCOS is not diagnosed</arm_group_label>
    <description>Forty patients who did not have any complaints between the ages of 18-35 who applied to the gynecology policlinic as a control group but who had no PCOS orany other systemic problems and were similar in terms of age group and body mass index were included in the study after being approved for participation in the study</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>study</intervention_name>
    <description>Scube-1 scube-2 scube-3</description>
    <arm_group_label>PCOS diagnosis area</arm_group_label>
    <arm_group_label>PCOS is not diagnosed</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        40 women diagnosed with PCOS between the ages of 18-35&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Clinical diagnosis of PCOS&#xD;
&#xD;
          -  18-35 years old&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Endocrinopathies (including diabetes mellitus, hyperprolactinemia, Cushing's disease&#xD;
             and congenital adrenal hyperplasia), systemic disease (eg asthma), collagen disorder,&#xD;
             hypercholesterolemia, sickle cell anemia or neoplasm,&#xD;
&#xD;
          -  Coronary artery disease , angina or myocardial infarction, or any known vascular,&#xD;
             infectious, or inflammatory disease, including hypertension, coronary arterioscitis,&#xD;
             and electrocardiographic changes;&#xD;
&#xD;
          -  Use of any medication (e.g., insulin sensitizing drugs, oral contraceptives,&#xD;
             antiandrogens, statins, aspirin, corticosteroids and gonadotropin releasing hormone&#xD;
             agonists and antagonists) within the previous 3 months;&#xD;
&#xD;
          -  Abnormal serum albumin concentration (normal concentration, 30-55 g / l),&#xD;
&#xD;
          -  Abnormal troponin I concentration,&#xD;
&#xD;
          -  Present smoker,&#xD;
&#xD;
          -  Abnormal renal, hepatic and thyroid function test results;&#xD;
&#xD;
          -  Refusing to participate in the work.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Süleyman Güven, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karadeniz TU Medicine Faculty</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Karadeniz Technical University Faculty of Medicine</name>
      <address>
        <city>Trabzon</city>
        <state>Ortahisar</state>
        <zip>61000</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>June 22, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>December 5, 2018</last_update_submitted>
  <last_update_submitted_qc>December 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karadeniz Technical University</investigator_affiliation>
    <investigator_full_name>Suleyman Guven</investigator_full_name>
    <investigator_title>Clinical professor</investigator_title>
  </responsible_party>
  <keyword>PCOS</keyword>
  <keyword>SCUBE</keyword>
  <keyword>Cardiovascular disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polycystic Ovary Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03765905
org study id: Karadeniz Technical University
nct id: NCT03765905
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to investigate serum SCUBE-1 and SCUBE-3 levels in PCOS and non-PCOS
      cases compared with non-PCOS healthy controls with similar age and body mass index
The aim of this study was to investigate serum SCUBE1 and SCUBE3 levels in PCOS and non-PCOS
      cases compared with non-PCOS healthy controls with similar age and body mass index.

      This will be a prospective clinical laboratory study,It will include women with PCOS
      diagnosis (according to the 2003 Rotherdam criteria). 40 cases of reproductive age will be
      included in the study group, which will be included in the survey after being approved for
      participation in the survey from field trials. Forty patients who will not have any
      complaints between the ages of 18-35 who will apply to the gynecology policlinic as a control
      group but who had no PCOS o rany other systemic problems and will be similar in terms of age
      group and body mass index will be included in the study after being approved for
      participation in the study. From the study and control group, 5 mL of blood will be taken
      from the untreated biochemical tube for serum SCUBE1 SCUBE2 SCUBE3. The blood samples will be
      centrifuged at 1000 g for 10 minutes and the serum fraction will be obtained and the serum
      will be stored at -80 ° C to be stored until the day of the tube operation. Serum SCUBE1,
      SCUBE2 SCUBE3 levels will be measured using ELISA kits. ,
observational model: Case-Control
time perspective: Prospective
measure: Serum SCUBE 1
time frame: 01.01.2017-31.12.2017
description: Serum scube1 in microgram
measure: Serum SCUBE 2
time frame: 01.01.2017-31.12.2017
description: Serum scube2 in microgram
measure: Serum SCUBE 3
time frame: 01.01.2017-31.12.2017
description: Serum scube3 in microgram
arm group label: PCOS diagnosis area
description: The study group consisted of 40 reproductive age women between 18th and 35th years old women who were PCOS diagnosis (according to the 2003 Rotherdam criteria)
arm group label: PCOS is not diagnosed
description: Forty patients who did not have any complaints between the ages of 18-35 who applied to the gynecology policlinic as a control group but who had no PCOS orany other systemic problems and were similar in terms of age group and body mass index were included in the study after being approved for participation in the study
intervention type: Diagnostic Test
intervention name: study
description: Scube-1 scube-2 scube-3
arm group label: PCOS diagnosis area
arm group label: PCOS is not diagnosed
Blood serum
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Süleyman Güven, Prof
role: Principal Investigator
affiliation: Karadeniz TU Medicine Faculty
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Karadeniz Technical University
investigator full name: Suleyman Guven
investigator title: Clinical professor
mesh term: Polycystic Ovary Syndrome
mesh term: Syndrome
sharing ipd: Undecided