<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/NCT03788824</url>
  </required_header>
  <id_info>
    <org_study_id>2014SDU-QILU-G05</org_study_id>
    <nct_id>NCT03788824</nct_id>
  </id_info>
  <brief_title>Evaluation of Inflammation Activity in Ulcerative Colitis by pCLE</brief_title>
  <official_title>Evaluation of Inflammation Activity in Ulcerative Colitis by Probe-based Confocal Laser Endomicroscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shandong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shandong University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim:1) To test the correlation of pCLE-obtained features with histological findings in&#xD;
      UC; comparing the real-time conventional colonoscopy Baron score with CLE assessment. 2) To&#xD;
      test the accuracy of the investigators previously proposed simplified four-grade&#xD;
      classification system of crypt architecture in evaluating inflammation activity in UC by&#xD;
      pCLE.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with acute inflammatory infiltrates seen on histological assessment are more likely&#xD;
      to experience relapse than are those without infiltrates,studies suggest that severity of&#xD;
      inflammation is a risk factor for colorectal neoplasia in UC.&#xD;
&#xD;
      The assessment of inflammation activity by conventional colonoscopy is inaccurate in the&#xD;
      prediction of acute inflammation in some cases. Confocal laser endomicroscopy (CLE) allows&#xD;
      for real-time endoscopy and histological diagnosis of gastrointestinal diseases. In our&#xD;
      previous study, we confirmed a simplified four-grade classification system of crypt&#xD;
      architecture(Grade A :normal; Grade B: an irregular arrangement of colonic crypts with normal&#xD;
      size and shape, and enlarged spaces between crypts; Type C: an enlarged crypt opening and a&#xD;
      more irregular crypt arrangement than type B; Type D: crypt destruction and / or crypt&#xD;
      abscess) by eCLE in predicting acute inflammation, and found a good correlation with&#xD;
      histology. In this study, the investigators aimed to test the accuracy of the proposed tne&#xD;
      four-grade classification system in evaluating inflammation activity in UC by pCLE.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">February 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2018</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>A valuable realtime- and offline- diagnosis of pCLE in evaluating the inflammation activity in UC.</measure>
    <time_frame>2 years</time_frame>
    <description>Recruited more than 100 UC patients,pCLE diagnostic criteria was the four-grades crypt architecture classification system ( inactive cases with Grade A or B, active with Grade C or D), histological assessment according to the Geboes Index ( inactive disease with Geboes index ≤ 3.0; active disease with a index &gt; 3.0). Using Spearman's text, calculating the corelation between pCLE real-time finding and the Geboes index, if p&lt;0.05, it means a strong corelation,vice versa. Also for the offline diagnosis.&#xD;
Also calculate the corelation between white-light colonoscopy (Baron Score) and histopathology.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Good or Excellent interobserver and intraobserver agreement of pCLE diagnosis.</measure>
    <time_frame>2 years</time_frame>
    <description>Assessment of interobserver variability of pCLE was conducted in a randomized pCLE videos' order by two independent investigators. After a 2-week interval, all pCLE videos were reassessed by the two investigators to evaluate the intraobserver agreement.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Inflammation</condition>
  <arm_group>
    <arm_group_label>pCLE group</arm_group_label>
    <description>pCLE is used to distinguish the inflammation activity of UC, and compared with histology</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      sample for histological examination&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive patients screened that fulfill the eligibility criteria at Qilu Hospital,&#xD;
        Shandong University will be enrolled into the study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or Female aged 18-80;&#xD;
&#xD;
          -  patients previously or in-process diagnosed as Ulcerative Colitis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with gastrectomy, acute GI bleeding, and advanced esophageal cancer;&#xD;
&#xD;
          -  Patients under conditions unsuitable for performing CLE including coagulopathy&#xD;
             (prothrombin time &lt;50% of control, partial thromboplastin time &gt;50 s), lactation, food&#xD;
             retention, oesophageal stenosis, postoperative cases, leiomyoma, impaired renal&#xD;
             function (creatinine level &gt;1.2 mg/dL), pregnancy or breastfeeding, and known allergy&#xD;
             to fluorescein sodium;&#xD;
&#xD;
          -  Inability to provide informed consent and other situations that could interfere with&#xD;
             the examination protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yanqing Li, MD. PhD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Qilu Hospital, Shandong University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yangqing li, PhD. MD</last_name>
    <phone>86-531-82169236</phone>
    <phone_ext>82169508</phone_ext>
    <email>liyanqing@sdu.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Gastroenterology, Qilu Hospital, Shandong University</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250012</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yanqing Li, MD. PhD.</last_name>
      <phone>86-531-82169236</phone>
      <phone_ext>82169508</phone_ext>
      <email>liyanqing@sdu.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 13, 2014</study_first_submitted>
  <study_first_submitted_qc>December 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <last_update_submitted>December 23, 2018</last_update_submitted>
  <last_update_submitted_qc>December 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shandong University</investigator_affiliation>
    <investigator_full_name>Yanqing Li</investigator_full_name>
    <investigator_title>Vice president of Qilu Hospital</investigator_title>
  </responsible_party>
  <keyword>Ulcerative Colitis</keyword>
  <keyword>probe-based Confocal Laser Endoscopy</keyword>
  <keyword>Inflammation Activity</keyword>
  <keyword>Histology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colitis</mesh_term>
    <mesh_term>Colitis, Ulcerative</mesh_term>
    <mesh_term>Inflammation</mesh_term>
    <mesh_term>Ulcer</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/NCT03788824
org study id: 2014SDU-QILU-G05
nct id: NCT03788824
lead sponsor: 
has dmc: Yes
The aim:1) To test the correlation of pCLE-obtained features with histological findings in
      UC; comparing the real-time conventional colonoscopy Baron score with CLE assessment. 2) To
      test the accuracy of the investigators previously proposed simplified four-grade
      classification system of crypt architecture in evaluating inflammation activity in UC by
      pCLE.
Patients with acute inflammatory infiltrates seen on histological assessment are more likely
      to experience relapse than are those without infiltrates,studies suggest that severity of
      inflammation is a risk factor for colorectal neoplasia in UC.

      The assessment of inflammation activity by conventional colonoscopy is inaccurate in the
      prediction of acute inflammation in some cases. Confocal laser endomicroscopy (CLE) allows
      for real-time endoscopy and histological diagnosis of gastrointestinal diseases. In our
      previous study, we confirmed a simplified four-grade classification system of crypt
      architecture(Grade A :normal; Grade B: an irregular arrangement of colonic crypts with normal
      size and shape, and enlarged spaces between crypts; Type C: an enlarged crypt opening and a
      more irregular crypt arrangement than type B; Type D: crypt destruction and / or crypt
      abscess) by eCLE in predicting acute inflammation, and found a good correlation with
      histology. In this study, the investigators aimed to test the accuracy of the proposed tne
      four-grade classification system in evaluating inflammation activity in UC by pCLE.
observational model: Cohort
time perspective: Prospective
measure: A valuable realtime- and offline- diagnosis of pCLE in evaluating the inflammation activity in UC.
time frame: 2 years
description: Recruited more than 100 UC patients,pCLE diagnostic criteria was the four-grades crypt architecture classification system ( inactive cases with Grade A or B, active with Grade C or D), histological assessment according to the Geboes Index ( inactive disease with Geboes index ≤ 3.0; active disease with a index > 3.0). Using Spearman's text, calculating the corelation between pCLE real-time finding and the Geboes index, if p<0.05, it means a strong corelation,vice versa. Also for the offline diagnosis.
Also calculate the corelation between white-light colonoscopy (Baron Score) and histopathology.
measure: Good or Excellent interobserver and intraobserver agreement of pCLE diagnosis.
time frame: 2 years
description: Assessment of interobserver variability of pCLE was conducted in a randomized pCLE videos' order by two independent investigators. After a 2-week interval, all pCLE videos were reassessed by the two investigators to evaluate the intraobserver agreement.
arm group label: pCLE group
description: pCLE is used to distinguish the inflammation activity of UC, and compared with histology
sample for histological examination
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Yanqing Li, MD. PhD.
role: Principal Investigator
affiliation: Qilu Hospital, Shandong University
last name: Yangqing li, PhD. MD
phone: 86-531-82169236
phone ext: 82169508
email: liyanqing@sdu.edu.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shandong University
investigator full name: Yanqing Li
investigator title: Vice president of Qilu Hospital
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Inflammation
mesh term: Ulcer