<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/NCT01675752</url>
  </required_header>
  <id_info>
    <org_study_id>CE ICH 37/11</org_study_id>
    <nct_id>NCT01675752</nct_id>
  </id_info>
  <brief_title>Small Hyperplastic and Adenomatous Reliability Protocol</brief_title>
  <acronym>SHARP</acronym>
  <official_title>Accuracy of Narrow Band Imaging in Predicting Colonoscopy Surveillance Intervals and Histology of Distal Diminutive Polyps (Small Hyperplastic and Adenomatous Reliability Protocol; SHARP Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituto Clinico Humanitas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Olympus</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Istituto Clinico Humanitas</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      1. Protocol Summary Title: SHARP: Small Hyperplastic and Adenomatous Reliability Protocol&#xD;
      Purpose: To compare the accuracy of NBI-in vivo differentiation between hyperplastic and&#xD;
      adenomatous &lt;10 mm polyps with that of histology in an European multi-center study. To assess&#xD;
      variability among endoscopists in NBI accuracy. We also aim to assess whether this technology&#xD;
      impacts the appropriateness of surveillance intervals.&#xD;
&#xD;
      Design: 1) Before starting the patient enrollment, the participating endoscopists will attend&#xD;
      an internet-based training program on the in vivo differentiation between hyperplastic and&#xD;
      adenomatous polyps. Following this course, a qualifying examination will be required for each&#xD;
      endoscopist to be included.&#xD;
&#xD;
      2) Patients who are scheduled for screening or diagnostic colonoscopy will be considered for&#xD;
      inclusion. Patients with at least one histologically verified &lt;10 mm polyp will be included.&#xD;
      In order to measure NBI feasibility, each included polyp will be in vivo assessed by NBI in&#xD;
      order to rank between a high- and a low- level of diagnostic confidence, and thereafter will&#xD;
      be sent for histological assessment. NBI- and histological accuracy in differentiating&#xD;
      between hyperplastic and adenomatous lesions will be analyzed and compared, in order to&#xD;
      assess the NBI-sensitivity and specificity. The primary outcomes are to measure the NBI&#xD;
      feasibility and accuracy in the study population, and to assess the variability among the&#xD;
      endoscopists. Secondary outcome measures will be a cost analysis on how much savings would be&#xD;
      achieved by not referring NBI-diagnosed hyperplastic polyps to histology, and a clinical&#xD;
      inference on how many patients would be scheduled for an inappropriate post-polypectomy&#xD;
      follow up, when follow up schedule is based on NBI classification. Clinical results will be&#xD;
      analyzed using various statistical measures of significance.&#xD;
&#xD;
      Clinical Site Locations: 10 European centres with NBI-technology&#xD;
&#xD;
      1 NBI-expert endoscopist for each centre Enrollment: 160 small (&lt;10 mm) polyps at each site&#xD;
      Study technology: NBI-Olympus without optical magnification Risk: Non-interventional study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2011</start_date>
  <completion_date type="Actual">July 2012</completion_date>
  <primary_completion_date type="Actual">May 2012</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <enrollment type="Actual">300</enrollment>
  <condition>Adenomatous Polyp</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive adult patients who were referred for elective outpatient colonoscopy will be&#xD;
        asked to enroll into this trial if the candidate meets the study inclusion and exclusion&#xD;
        criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. The patient is undergoing colonoscopy for screening, for surveillance in follow-up&#xD;
             of previous polypectomy or for diagnostic work-up; 2. The patient is at satisfactory&#xD;
             risk to undergo abdominal surgery; 3. The patient must understand and provide written&#xD;
             consent for the procedure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. The patient is undergoing colonoscopy for screening, for surveillance in follow-up&#xD;
             of previous polypectomy or for diagnostic work-up; 2. The patient is at satisfactory&#xD;
             risk to undergo abdominal surgery; 3. The patient must understand and provide written&#xD;
             consent for the procedure.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <last_update_submitted>August 28, 2012</last_update_submitted>
  <last_update_submitted_qc>August 28, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 30, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>colonoscopy, narrow-band imaging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenomatous Polyps</mesh_term>
    <mesh_term>Polyps</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/NCT01675752
org study id: CE ICH 37/11
nct id: NCT01675752
lead sponsor: 
collaborator: 
has dmc: No
1. Protocol Summary Title: SHARP: Small Hyperplastic and Adenomatous Reliability Protocol
      Purpose: To compare the accuracy of NBI-in vivo differentiation between hyperplastic and
      adenomatous <10 mm polyps with that of histology in an European multi-center study. To assess
      variability among endoscopists in NBI accuracy. We also aim to assess whether this technology
      impacts the appropriateness of surveillance intervals.

      Design: 1) Before starting the patient enrollment, the participating endoscopists will attend
      an internet-based training program on the in vivo differentiation between hyperplastic and
      adenomatous polyps. Following this course, a qualifying examination will be required for each
      endoscopist to be included.

      2) Patients who are scheduled for screening or diagnostic colonoscopy will be considered for
      inclusion. Patients with at least one histologically verified <10 mm polyp will be included.
      In order to measure NBI feasibility, each included polyp will be in vivo assessed by NBI in
      order to rank between a high- and a low- level of diagnostic confidence, and thereafter will
      be sent for histological assessment. NBI- and histological accuracy in differentiating
      between hyperplastic and adenomatous lesions will be analyzed and compared, in order to
      assess the NBI-sensitivity and specificity. The primary outcomes are to measure the NBI
      feasibility and accuracy in the study population, and to assess the variability among the
      endoscopists. Secondary outcome measures will be a cost analysis on how much savings would be
      achieved by not referring NBI-diagnosed hyperplastic polyps to histology, and a clinical
      inference on how many patients would be scheduled for an inappropriate post-polypectomy
      follow up, when follow up schedule is based on NBI classification. Clinical results will be
      analyzed using various statistical measures of significance.

      Clinical Site Locations: 10 European centres with NBI-technology

      1 NBI-expert endoscopist for each centre Enrollment: 160 small (<10 mm) polyps at each site
      Study technology: NBI-Olympus without optical magnification Risk: Non-interventional study.
observational model: Cohort
time perspective: Cross-Sectional
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Adenomatous Polyps
mesh term: Polyps