<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/NCT02190071</url>
  </required_header>
  <id_info>
    <org_study_id>SNUBH-IMGPB-2014-03</org_study_id>
    <nct_id>NCT02190071</nct_id>
  </id_info>
  <brief_title>Comparison Between Base and Cover Slide From Endoscopic Ultrasound Guided Fine Needle Aspiration for Pancreatic Cancer</brief_title>
  <acronym>EUS-FNA</acronym>
  <official_title>Comparison of the Diagnostic Accuracy Between Base and Cover Slide Smear After Endoscopic Ultrasound Guided Fine Needle Aspiration for Pancreatic Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether there is a difference of diagnostic&#xD;
      accuracy between cover slides and base slides from EUS-FNA cytopathologic sample in patients&#xD;
      who were previously suspected of pancreatic cancer in radiologic test.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. background&#xD;
&#xD;
             1. Pancreatic cancer is the challenging malignancy in diagnosis and treatment.&#xD;
&#xD;
             2. Recently, EUS-FNA has played a important role in diagnosing pancreatic cancer.&#xD;
&#xD;
             3. Samples from EUS-FNA are sent to following three types of preparations.&#xD;
&#xD;
                  -  cytologic smear (by pull apart method)&#xD;
&#xD;
                  -  cell block&#xD;
&#xD;
                  -  histologic biopsy&#xD;
&#xD;
             4. In cytologic smear method, endoscopists tend to send as many as slides, while&#xD;
                pathologists want minimal slides if they warrant diagnostic accuracy.&#xD;
&#xD;
             5. Therefore we are going to find a point of contact between high diagnostic yield and&#xD;
                minimal overloading of pathologist.&#xD;
&#xD;
        2. Method&#xD;
&#xD;
             1. We are going to enrolled the patients who were suspected of pancreatic cancer in&#xD;
                previous radiologic test.&#xD;
&#xD;
             2. One identical and skilled endoscopist performs EUS-FNA with multiple punctures.&#xD;
&#xD;
             3. We get total 8 pairs of slides (= 8 covers + 8 bases).&#xD;
&#xD;
             4. All the cover slides are collected to the bottle-A, all the base slide to the&#xD;
                bottle-B.&#xD;
&#xD;
             5. One identical and skilled pathologist inspects these slide in blind method. (She&#xD;
                cannot show the label of bottle so that she does not know what bottle is A or B.)&#xD;
&#xD;
             6. She record the positive or negative in each bottle. (If there is only one slide is&#xD;
                positive in malignant cell, the bottle is positive.)&#xD;
&#xD;
             7. In these manner, we collect the all subjects' cytopathologic results as a pair of&#xD;
                outcome. All the possible combinations are following four examples:&#xD;
&#xD;
                  -  (cover/base) = (positive/positive) = (+/+)&#xD;
&#xD;
                  -  (cover/base) = (positive/negative) = (+/-)&#xD;
&#xD;
                  -  (cover/base) = (negative/positive) = (-/+)&#xD;
&#xD;
                  -  (cover/base) = (negative/negative) = (-/-)&#xD;
&#xD;
             8. Then we are going to take a two-sided non-inferiority test of proportion using&#xD;
                McNemar's test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</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>positive malignancy rate of cover slides set and base slides set.</measure>
    <time_frame>cytopathological report within 2 weeks after EUS-FNA</time_frame>
    <description>comparison between diagnostic accuracy between cover slide sets and base slide sets</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>positive malignancy rate of (1) cytologic smear, (2) cell block and (3) histologic biopsy</measure>
    <time_frame>record of pathologist within 2 weeks after EUS-FNA</time_frame>
    <description>comparison of three types of test in rate of positive malignancy</description>
  </secondary_outcome>
  <enrollment type="Actual">73</enrollment>
  <condition>Pancreatic Cancer</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      One identical and skilled endoscopist's EUS-FNA sampling with multiple punctures&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The patients who visited to tertiary medical center(Seoul National University Bundang&#xD;
        Hospital) because of suspicious pancreatic cancer in radiologic study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who were suspected of pancreatic cancer in previous radiologic test such as&#xD;
             computed tomography, magnetic resonance imaging or Positron Emission Tomography.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  failed smear due to inexperienced assistant&#xD;
&#xD;
          -  loss of slide&#xD;
&#xD;
          -  patients who were diagnosed with other lesion far from pancreatic cancer in&#xD;
             prospective confirmative tests.&#xD;
&#xD;
          -  patients who refuse to participate in this study&#xD;
&#xD;
          -  report of other pathologist who are not a previously-assigned pathologist&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jaihwan Kim, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Seoul National University Bundang Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam</city>
        <state>Gyeonggi-do</state>
        <zip>463-707</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>July 6, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>May 25, 2016</last_update_submitted>
  <last_update_submitted_qc>May 25, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 27, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>EUS-FNA</keyword>
  <keyword>cytopathology</keyword>
  <keyword>slide smear</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>November 3, 2019</submitted>
    <returned>November 20, 2019</returned>
  </pending_results>
  <!-- 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/NCT02190071
org study id: SNUBH-IMGPB-2014-03
nct id: NCT02190071
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine whether there is a difference of diagnostic
      accuracy between cover slides and base slides from EUS-FNA cytopathologic sample in patients
      who were previously suspected of pancreatic cancer in radiologic test.
1. background

             1. Pancreatic cancer is the challenging malignancy in diagnosis and treatment.

             2. Recently, EUS-FNA has played a important role in diagnosing pancreatic cancer.

             3. Samples from EUS-FNA are sent to following three types of preparations.

                  -  cytologic smear (by pull apart method)

                  -  cell block

                  -  histologic biopsy

             4. In cytologic smear method, endoscopists tend to send as many as slides, while
                pathologists want minimal slides if they warrant diagnostic accuracy.

             5. Therefore we are going to find a point of contact between high diagnostic yield and
                minimal overloading of pathologist.

        2. Method

             1. We are going to enrolled the patients who were suspected of pancreatic cancer in
                previous radiologic test.

             2. One identical and skilled endoscopist performs EUS-FNA with multiple punctures.

             3. We get total 8 pairs of slides (= 8 covers + 8 bases).

             4. All the cover slides are collected to the bottle-A, all the base slide to the
                bottle-B.

             5. One identical and skilled pathologist inspects these slide in blind method. (She
                cannot show the label of bottle so that she does not know what bottle is A or B.)

             6. She record the positive or negative in each bottle. (If there is only one slide is
                positive in malignant cell, the bottle is positive.)

             7. In these manner, we collect the all subjects' cytopathologic results as a pair of
                outcome. All the possible combinations are following four examples:

                  -  (cover/base) = (positive/positive) = (+/+)

                  -  (cover/base) = (positive/negative) = (+/-)

                  -  (cover/base) = (negative/positive) = (-/+)

                  -  (cover/base) = (negative/negative) = (-/-)

             8. Then we are going to take a two-sided non-inferiority test of proportion using
                McNemar's test.
observational model: Cohort
time perspective: Prospective
measure: positive malignancy rate of cover slides set and base slides set.
time frame: cytopathological report within 2 weeks after EUS-FNA
description: comparison between diagnostic accuracy between cover slide sets and base slide sets
measure: positive malignancy rate of (1) cytologic smear, (2) cell block and (3) histologic biopsy
time frame: record of pathologist within 2 weeks after EUS-FNA
description: comparison of three types of test in rate of positive malignancy
One identical and skilled endoscopist's EUS-FNA sampling with multiple punctures
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Jaihwan Kim, M.D.
role: Study Chair
affiliation: Seoul National University Bundang Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms
submitted: November 3, 2019
returned: November 20, 2019