<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/NCT01699698</url>
  </required_header>
  <id_info>
    <org_study_id>OMSC-PJD-1</org_study_id>
    <nct_id>NCT01699698</nct_id>
  </id_info>
  <brief_title>Pancreatic Juice Diagnosis From Duodenum</brief_title>
  <official_title>Pancreatic Juice Diagnosis From Duodenum</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Olympus Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kyushu University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The University of Texas Health Science Center, Houston</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Olympus Corporation</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose of this study is to understand the clinical feasibility of duodenal juice diagnosis&#xD;
      to screen UICC stage II pancreatic ductal adenocarcinoma patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pancreatic cancer (PC) is the most lethal of all major cancers with a five year survival rate&#xD;
      of 5 %. While stage I and II tumors leads to an improvement in survival, almost all PCs are&#xD;
      currently diagnosed at more advanced non-resectable stages since minimally invasive technique&#xD;
      which is capable of screening early-stage PC does not exist. Serum CA19-9 is not recommended&#xD;
      as a screening technique because of its low sensitivity and specificity. Imaging modalities&#xD;
      such as MRI, CT, EUS and ERCP are more accurate but are not appropriate screening tools due&#xD;
      to their high cost, discomfort and complications. Therefore, there is a strong demand for a&#xD;
      screening tool with high sensitivity and specificity which is highly acceptable for the&#xD;
      patient.&#xD;
&#xD;
      The investigators would like to standardize the detection method of pancreatic cancer that&#xD;
      uses the duodenal juice as an optional endoscopic diagnosis. It's a very useful chance to&#xD;
      collect pancreatic juice from duodenum, it is called &quot;duodenal juice&quot; ,if we collect them&#xD;
      without additional invasion. The investigators would like to collect duodenal juice during&#xD;
      undergoing upper gastrointestinal endoscopy and analyze the pancreatic tumor markers in&#xD;
      duodenal juice. A definite diagnosis of the patient is made with histology, cytology or&#xD;
      imaging diagnosis and the result of each definite diagnosis is correlated to the each marker&#xD;
      analyzing result of duodenal juice. Therefore this study can be positioned as a feasibility&#xD;
      study to confirm clinical performance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <primary_completion_date type="Actual">July 2014</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>Diagnostic</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Concentration of the Pancreatic Cancer Markers of the Normal Cohort and UICC Stage II Pancreatic Ductal Adenocarcinoma Cohort</measure>
    <time_frame>1year</time_frame>
    <description>We hypothesized that there is a statistically-significant difference between two cohorts.&#xD;
The cancer marker is S100P.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Sensitivity and Specificity to Detect UICC Stage II Pancreatic Ductal Adenocarcinoma Among All Participants.</measure>
    <time_frame>1 year</time_frame>
    <description>Based on each analyzing result of pancreatic cancer markers and corresponding final diagnosis, a receiver operating characteristic (ROC) is evaluated. A cut-off is then chosen from this ROC curve to maximize both sensitivity and specificity.&lt;Method&gt;1. create an ROC curve using the measured concentrations, 2. set a threshold, 3. report how many patients in each group would are exceeded the threshold. (The rate of exceeded threshold in Test subject group is sensitivity, The rate of 1-(the rate of exceeded threshold in Control group) is specificity.)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">105</enrollment>
  <condition>Pancreatic Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>Test subject</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Tumor markers</intervention_name>
    <description>Duodenal juice are collected using endoscope and cannula. Tumor markers of collected samples are analyzed. The marker concentration is applied to statistical analysis.</description>
    <arm_group_label>Test subject</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Common inclusion criterion&#xD;
&#xD;
          -  Age is 18 years or older.&#xD;
&#xD;
          -  Informed consent was obtained.&#xD;
&#xD;
          -  Inclusion criterion for normal cohort&#xD;
&#xD;
          -  An upper GI endoscopy is scheduled to check upper abdominal symptoms.&#xD;
&#xD;
          -  No findings of pancreatic disorder as documented by CT or MRI or EUS&#xD;
&#xD;
          -  Inclusion criterion for PC suspicious cohort&#xD;
&#xD;
          -  A EUS or ERCP is scheduled to suspected pancreatic disorder.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Common exclusion criterion&#xD;
&#xD;
          -  Severe cardiac disease&#xD;
&#xD;
          -  Severe respiratory disease&#xD;
&#xD;
          -  Bleeding disorders&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Massimo Raimondo, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic Jacksonville</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyushu University</name>
      <address>
        <city>Fukuoka-shi</city>
        <state>Fukuoka-ken</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Pungpapong S, Noh KW, Woodward TA, Wallace MB, Al-Haddad M, Raimondo M. Endoscopic ultrasound and IL-8 in pancreatic juice to diagnose chronic pancreatitis. Pancreatology. 2007;7(5-6):491-6. doi: 10.1159/000108966. Epub 2007 Oct 1.</citation>
    <PMID>17912013</PMID>
  </reference>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>September 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <results_first_submitted>June 30, 2015</results_first_submitted>
  <results_first_submitted_qc>August 4, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">September 3, 2015</results_first_posted>
  <last_update_submitted>September 2, 2015</last_update_submitted>
  <last_update_submitted_qc>September 2, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 21, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pancreatic adenocarcinoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Test Subject</title>
          <description>UICC StageII pancreatic ductal adenocarcinoma cohort</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>Normal cohort</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="61"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="56"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Test Subject</title>
          <description>UICC Stage II pancreatic ductal adenocarcinoma cohort</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>Normal cohort</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="42"/>
            <count group_id="B2" value="56"/>
            <count group_id="B3" value="98"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70" lower_limit="49" upper_limit="88"/>
                    <measurement group_id="B2" value="60" lower_limit="23" upper_limit="81"/>
                    <measurement group_id="B3" value="64" lower_limit="23" upper_limit="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Japan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Concentration of the Pancreatic Cancer Markers of the Normal Cohort and UICC Stage II Pancreatic Ductal Adenocarcinoma Cohort</title>
        <description>We hypothesized that there is a statistically-significant difference between two cohorts.&#xD;
The cancer marker is S100P.</description>
        <time_frame>1year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Test Subject</title>
            <description>UICC Stage II pancreatic ductal adenocarcinoma cohort</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Normal cohort</description>
          </group>
        </group_list>
        <measure>
          <title>The Concentration of the Pancreatic Cancer Markers of the Normal Cohort and UICC Stage II Pancreatic Ductal Adenocarcinoma Cohort</title>
          <description>We hypothesized that there is a statistically-significant difference between two cohorts.&#xD;
The cancer marker is S100P.</description>
          <units>pg/ml</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99097" lower_limit="7386" upper_limit="1985933"/>
                    <measurement group_id="O2" value="34095" lower_limit="611" upper_limit="497630"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Sensitivity and Specificity to Detect UICC Stage II Pancreatic Ductal Adenocarcinoma Among All Participants.</title>
        <description>Based on each analyzing result of pancreatic cancer markers and corresponding final diagnosis, a receiver operating characteristic (ROC) is evaluated. A cut-off is then chosen from this ROC curve to maximize both sensitivity and specificity.&lt;Method&gt;1. create an ROC curve using the measured concentrations, 2. set a threshold, 3. report how many patients in each group would are exceeded the threshold. (The rate of exceeded threshold in Test subject group is sensitivity, The rate of 1-(the rate of exceeded threshold in Control group) is specificity.)</description>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Test Subject</title>
            <description>UICC StageII pancreatic ductal adenocarcinoma cohort</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Normal cohort</description>
          </group>
        </group_list>
        <measure>
          <title>The Sensitivity and Specificity to Detect UICC Stage II Pancreatic Ductal Adenocarcinoma Among All Participants.</title>
          <description>Based on each analyzing result of pancreatic cancer markers and corresponding final diagnosis, a receiver operating characteristic (ROC) is evaluated. A cut-off is then chosen from this ROC curve to maximize both sensitivity and specificity.&lt;Method&gt;1. create an ROC curve using the measured concentrations, 2. set a threshold, 3. report how many patients in each group would are exceeded the threshold. (The rate of exceeded threshold in Test subject group is sensitivity, The rate of 1-(the rate of exceeded threshold in Control group) is specificity.)</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Test Subject</title>
          <description>UICC StageII pancreatic ductal adenocarcinoma cohort</description>
        </group>
        <group group_id="E2">
          <title>Normal</title>
          <description>Normal cohort</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Sponsor can ask PI to consider that PI delete Sponsor's confidential information from any publication or extend the publication for a certain time to seek patent protection, provided, however that, PI can publish or registry any other information in accordance with FDAAA.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Taketo Matsunaga</name_or_title>
      <organization>Kyushu University</organization>
      <phone>092-642-5444</phone>
      <email>mtaketo@surg1.med.kyushu-u.ac.jp</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01699698
org study id: OMSC-PJD-1
nct id: NCT01699698
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Purpose of this study is to understand the clinical feasibility of duodenal juice diagnosis
      to screen UICC stage II pancreatic ductal adenocarcinoma patients.
Pancreatic cancer (PC) is the most lethal of all major cancers with a five year survival rate
      of 5 %. While stage I and II tumors leads to an improvement in survival, almost all PCs are
      currently diagnosed at more advanced non-resectable stages since minimally invasive technique
      which is capable of screening early-stage PC does not exist. Serum CA19-9 is not recommended
      as a screening technique because of its low sensitivity and specificity. Imaging modalities
      such as MRI, CT, EUS and ERCP are more accurate but are not appropriate screening tools due
      to their high cost, discomfort and complications. Therefore, there is a strong demand for a
      screening tool with high sensitivity and specificity which is highly acceptable for the
      patient.

      The investigators would like to standardize the detection method of pancreatic cancer that
      uses the duodenal juice as an optional endoscopic diagnosis. It's a very useful chance to
      collect pancreatic juice from duodenum, it is called "duodenal juice" ,if we collect them
      without additional invasion. The investigators would like to collect duodenal juice during
      undergoing upper gastrointestinal endoscopy and analyze the pancreatic tumor markers in
      duodenal juice. A definite diagnosis of the patient is made with histology, cytology or
      imaging diagnosis and the result of each definite diagnosis is correlated to the each marker
      analyzing result of duodenal juice. Therefore this study can be positioned as a feasibility
      study to confirm clinical performance.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Outcomes Assessor)
measure: The Concentration of the Pancreatic Cancer Markers of the Normal Cohort and UICC Stage II Pancreatic Ductal Adenocarcinoma Cohort
time frame: 1year
description: We hypothesized that there is a statistically-significant difference between two cohorts.
The cancer marker is S100P.
measure: The Sensitivity and Specificity to Detect UICC Stage II Pancreatic Ductal Adenocarcinoma Among All Participants.
time frame: 1 year
description: Based on each analyzing result of pancreatic cancer markers and corresponding final diagnosis, a receiver operating characteristic (ROC) is evaluated. A cut-off is then chosen from this ROC curve to maximize both sensitivity and specificity.<Method>1. create an ROC curve using the measured concentrations, 2. set a threshold, 3. report how many patients in each group would are exceeded the threshold. (The rate of exceeded threshold in Test subject group is sensitivity, The rate of 1-(the rate of exceeded threshold in Control group) is specificity.)
arm group label: Test subject
arm group type: Experimental
intervention type: Other
intervention name: Tumor markers
description: Duodenal juice are collected using endoscope and cannula. Tumor markers of collected samples are analyzed. The marker concentration is applied to statistical analysis.
arm group label: Test subject
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Massimo Raimondo, M.D.
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
facility: 
country: Japan
country: United States
citation: Pungpapong S, Noh KW, Woodward TA, Wallace MB, Al-Haddad M, Raimondo M. Endoscopic ultrasound and IL-8 in pancreatic juice to diagnose chronic pancreatitis. Pancreatology. 2007;7(5-6):491-6. doi: 10.1159/000108966. Epub 2007 Oct 1.
PMID: 17912013
responsible party type: Sponsor
mesh term: Adenocarcinoma
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 