<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/NCT02231385</url>
  </required_header>
  <id_info>
    <org_study_id>The &quot;ACE&quot; Study</org_study_id>
    <nct_id>NCT02231385</nct_id>
  </id_info>
  <brief_title>Acetic Acid Colonoscopy Enhancement Study</brief_title>
  <official_title>Acetic Acid Colonoscopy Enhancement Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituto Clinico Humanitas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nuovo Regina Margherita Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Istituto Clinico Humanitas</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the additional diagnostic yield obtained by using the&#xD;
      acetic acid as vital substance to improve the detection of serrated lesions at colonoscopy.&#xD;
&#xD;
      Patients who are scheduled for screening, surveillance or diagnostic colonoscopy will be&#xD;
      recruited to the study and randomized to one of two groups. Each enrolled subject will&#xD;
      undergo two &quot;back-to-back&quot; procedures limited to the examination of the right colon.&#xD;
&#xD;
      Subjects in Group A (study group) will undergo a standard colonoscopy. Once the right colon&#xD;
      has been fully examined, acetic acid 2% will be sprayed and the right colon re-examined from&#xD;
      cecum to hepatic flexure with within a frame-time of two minutes. Subjects in Group B&#xD;
      (control group) will undergo a second examination of the right colon without acid acetic and&#xD;
      within the same frame-time.&#xD;
&#xD;
      Results from the two groups will be analyzed and compared, with primary outcome measures&#xD;
      being detection rates for serrated lesions. Secondary outcome measures will include adenoma&#xD;
      detection rate in the right colon or other locations, characteristics of polyps detected,&#xD;
      including size and histological results.&#xD;
&#xD;
      Subjects will be followed through a 24-72 hour telephone interview for analysis of unexpected&#xD;
      adverse events. Clinical results will be analyzed using various statistical measures of&#xD;
      significance.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">June 2015</completion_date>
  <primary_completion_date type="Anticipated">January 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Additional serrated lesions diagnosed after acetic acid spraying</measure>
    <time_frame>12 months</time_frame>
    <description>Primary outcome is the additional number of serrated lesions detected at the level of the right colon after spraying of acetic acid and compared with the number of the same lesions detected after a second examination of the right colon using standard white-light high definition scopes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>- Number of new adenoma detected at second right colon examination in both studies group</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of overall serrated and/or adenomatous lesions in the whole colon</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characteristic of lesions detected (size, morphology)</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complication rate</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Colorectal Cancer</condition>
  <condition>Serrated Adenomas</condition>
  <condition>Colon Nos Polypectomy Tubular Adenoma</condition>
  <arm_group>
    <arm_group_label>Acetic Acid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in Group A (study group) will undergo a standard colonoscopy. Once the right colon has been fully examined, acetic acid 2% will be sprayed and the right colon re-examined from cecum to hepatic flexure with within a frame-time of two minutes.&#xD;
Subjects in Group B (control group) will undergo a second examination of the right colon without acid acetic and within the same frame-time.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects in Group A (study group) will undergo a standard colonoscopy. Once the right colon has been fully examined, acetic acid 2% will be sprayed and the right colon re-examined from cecum to hepatic flexure with within a frame-time of two minutes.&#xD;
Subjects in Group B (control group) will undergo a second examination of the right colon without acid acetic and within the same frame-time.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acetic Acid</intervention_name>
    <description>Subjects in Group A (study group) will undergo a standard colonoscopy. Once the right colon has been fully examined, acetic acid 2% will be sprayed and the right colon re-examined from cecum to hepatic flexure with within a frame-time of two minutes.&#xD;
Subjects in Group B (control group) will undergo a second examination of the right colon without acid acetic and within the same frame-time.</description>
    <arm_group_label>Acetic Acid</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The patient is &gt;40 years old&#xD;
&#xD;
          2. The patient is undergoing colonoscopy for screening, for surveillance in follow-up of&#xD;
             previous polypectomy or for diagnostic workup;&#xD;
&#xD;
          3. The patient must understand and provide written consent for the procedure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with a history of colonic resection;&#xD;
&#xD;
          2. Patients with inflammatory bowel disease;&#xD;
&#xD;
          3. Patients with a personal history of polyposis syndrome;&#xD;
&#xD;
          4. Patients with suspected chronic stricture potentially precluding complete colonoscopy;&#xD;
&#xD;
          5. Patients with diverticulitis or toxic megacolon;&#xD;
&#xD;
          6. Patients with a history of radiation therapy to abdomen or pelvis;&#xD;
&#xD;
          7. Patients who are currently enrolled in another clinical investigation in which the&#xD;
             intervention might compromise the safety of the patient's participation in this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alessandro Repici, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Humanitas Research Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Cesare Hassan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nuovo Regina Margherita Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Alessandro Repici, MD</last_name>
    <phone>+390282247493</phone>
    <email>alessandro.repici@humanitas.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>Nuovo Regina Margherita Hospital</name>
      <address>
        <city>Rome</city>
        <zip>00153</zip>
        <country>Italy</country>
      </address>
    </facility>
    <contact>
      <last_name>Cesare Hassan, MD</last_name>
      <phone>+3906 77301</phone>
      <email>cesareh@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Cesare Hassan, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Humanitas Research Hospital</name>
      <address>
        <city>Rozzano, Milan</city>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
    <contact>
      <last_name>Alessandro Repici, MD</last_name>
      <phone>+390282247493</phone>
      <email>alessandro.repici@humanitas.it</email>
    </contact>
    <investigator>
      <last_name>Alessandro Repici, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 1, 2014</study_first_submitted>
  <study_first_submitted_qc>September 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <last_update_submitted>September 1, 2014</last_update_submitted>
  <last_update_submitted_qc>September 1, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 4, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istituto Clinico Humanitas</investigator_affiliation>
    <investigator_full_name>Michele Tedeschi</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Colorectal cancer</keyword>
  <keyword>Serrated adenomas</keyword>
  <keyword>Screening</keyword>
  <keyword>Adenoma detection rate</keyword>
  <keyword>Polypectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Adenoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetic Acid</mesh_term>
    <mesh_term>Retinol acetate</mesh_term>
  </intervention_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/NCT02231385
org study id: The "ACE" Study
nct id: NCT02231385
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to compare the additional diagnostic yield obtained by using the
      acetic acid as vital substance to improve the detection of serrated lesions at colonoscopy.

      Patients who are scheduled for screening, surveillance or diagnostic colonoscopy will be
      recruited to the study and randomized to one of two groups. Each enrolled subject will
      undergo two "back-to-back" procedures limited to the examination of the right colon.

      Subjects in Group A (study group) will undergo a standard colonoscopy. Once the right colon
      has been fully examined, acetic acid 2% will be sprayed and the right colon re-examined from
      cecum to hepatic flexure with within a frame-time of two minutes. Subjects in Group B
      (control group) will undergo a second examination of the right colon without acid acetic and
      within the same frame-time.

      Results from the two groups will be analyzed and compared, with primary outcome measures
      being detection rates for serrated lesions. Secondary outcome measures will include adenoma
      detection rate in the right colon or other locations, characteristics of polyps detected,
      including size and histological results.

      Subjects will be followed through a 24-72 hour telephone interview for analysis of unexpected
      adverse events. Clinical results will be analyzed using various statistical measures of
      significance.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Additional serrated lesions diagnosed after acetic acid spraying
time frame: 12 months
description: Primary outcome is the additional number of serrated lesions detected at the level of the right colon after spraying of acetic acid and compared with the number of the same lesions detected after a second examination of the right colon using standard white-light high definition scopes
measure: - Number of new adenoma detected at second right colon examination in both studies group
time frame: 12 months
measure: Number of overall serrated and/or adenomatous lesions in the whole colon
time frame: 12 months
measure: Characteristic of lesions detected (size, morphology)
time frame: 12 months
measure: Complication rate
time frame: 12 months
arm group label: Acetic Acid
arm group type: Experimental
description: Subjects in Group A (study group) will undergo a standard colonoscopy. Once the right colon has been fully examined, acetic acid 2% will be sprayed and the right colon re-examined from cecum to hepatic flexure with within a frame-time of two minutes.
Subjects in Group B (control group) will undergo a second examination of the right colon without acid acetic and within the same frame-time.
arm group label: Control Group
arm group type: No Intervention
description: Subjects in Group A (study group) will undergo a standard colonoscopy. Once the right colon has been fully examined, acetic acid 2% will be sprayed and the right colon re-examined from cecum to hepatic flexure with within a frame-time of two minutes.
Subjects in Group B (control group) will undergo a second examination of the right colon without acid acetic and within the same frame-time.
intervention type: Drug
intervention name: Acetic Acid
description: Subjects in Group A (study group) will undergo a standard colonoscopy. Once the right colon has been fully examined, acetic acid 2% will be sprayed and the right colon re-examined from cecum to hepatic flexure with within a frame-time of two minutes.
Subjects in Group B (control group) will undergo a second examination of the right colon without acid acetic and within the same frame-time.
arm group label: Acetic Acid
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Alessandro Repici, MD
role: Principal Investigator
affiliation: Humanitas Research Hospital
last name: Cesare Hassan, MD
role: Principal Investigator
affiliation: Nuovo Regina Margherita Hospital
last name: Alessandro Repici, MD
phone: +390282247493
email: alessandro.repici@humanitas.it
facility: 
contact: 
investigator: 
facility: 
contact: 
investigator: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Istituto Clinico Humanitas
investigator full name: Michele Tedeschi
investigator title: MD
mesh term: Colorectal Neoplasms
mesh term: Adenoma
mesh term: Acetic Acid
mesh term: Retinol acetate