xml: <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/NCT05983315</url>
    </required_header>
    <id_info>
      <org_study_id>69HCL21_0780</org_study_id>
      <nct_id>NCT05983315</nct_id>
    </id_info>
    <brief_title>Prospective Assessment of CONECCT's Classification for Colorectal Lesions.</brief_title>
    <acronym>pro-CONECCT</acronym>
    <official_title>Prospective Assessment of CONECCT's Classification for Histological Predictive Diagnostic Value in Conducting Therapeutic Choice for Colorectal Lesions. Pro-CONECCT</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hospices Civils de Lyon</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hospices Civils de Lyon</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Colorectal neoplastic lesion endoscopic characterization is a key element for histological&#xD;
        predictive diagnostic value in conducting best appropriate resection choice. Six&#xD;
        classifications are necessary for fully correct characterization of different colorectal&#xD;
        lesions. Nonetheless, it can be tricky to use so many diagnostic tools with so many&#xD;
        subcategories in the 6 existing classifications. That's why we decided to integrate all 6&#xD;
        existing classification validated factors in one single chart (CONECCT chart) allowing to&#xD;
        both predict histological diagnostic value and to propose the best appropriate resection&#xD;
        strategy. A previous prospective and multicentre study with all French medical residents in&#xD;
        gastroenterology was conducted in order to prove pedagogic interest of this diagnostic tool.&#xD;
        Each student was asked to review 20 files with lesion pictures before and after lecture about&#xD;
        CONECCT chart. This allowed us to prove that this diagnostic tool could significantly improve&#xD;
        both histological predictive diagnostic value and therapeutic choice by French medical&#xD;
        residents and gastroenterologists. Our hypothesis is that CONECCT's classification can&#xD;
        improve predictive diagnostic value of colorectal lesions in over 80% of cases. Now that&#xD;
        pedagogic interest of this diagnostic tool has been proven, we would like to carry out a&#xD;
        larger prospective assessment in term of performance (value) of this instrument in order to&#xD;
        both facilitate endoscopic characterization and allow a most appropriate diagnostic and&#xD;
        therapeutic management of each colorectal lesion category.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 1, 2021</start_date>
    <completion_date type="Actual">November 1, 2022</completion_date>
    <primary_completion_date type="Actual">July 1, 2022</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>Correlation between endoscopic CONECCT's classification</measure>
      <time_frame>Time point can be reached either 2 weeks after endoscopic resection at V1 or between 2-4 months later in case of surgery at V3</time_frame>
      <description>assessed by one of research site operators and final histology reading of neoplastic lesion by anatomopathologist:&#xD;
  CONECCT 0E : neuroendocrine tumor&#xD;
  CONECCT IH : hyperplastic polyp&#xD;
  CONECCT IS : sessile serrated lesion with or without dysplasia&#xD;
  CONECCT IIA : low or high grade adenoma&#xD;
  CONECCT IIC : low or high grade adenoma or intramucosal or submucosal &lt;1000 micron adenocarcinoma&#xD;
  CONECCT III : deep invasive submucosal &gt; 1000 microns adenocarcinoma</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">750</enrollment>
    <condition>Colorectal Cancer</condition>
    <arm_group>
      <arm_group_label>CONECCT's classification assessment</arm_group_label>
      <description>Every patient who needs diagnostic colonoscopy because of digestive symptoms, medical or family history of colorectal cancer/polyps, positive colorectal screening test, acromegaly or referred by another gastroenterologist upon discovery of colorectal polyp after colonoscopy can join the cohort of this study and can get CONECCT's classification histological assessment of their neoplastic lesion by experienced endoscopist.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Every patient who needs diagnostic colonoscopy because of digestive symptoms, medical or&#xD;
          family history of colorectal cancer/polyps, positive colorectal screening test, acromegaly&#xD;
          or referred by another gastroenterologist upon discovery of colorectal polyp after&#xD;
          colonoscopy can join the cohort of this study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          -  Inclusion Criteria :&#xD;
  &#xD;
                 -  both gender patients even or older than 18 years old&#xD;
  &#xD;
                 -  patient in need of proven diagnostic or therapeutic colonoscopy for colorectal&#xD;
                    lesion resection&#xD;
  &#xD;
                 -  patient with French Health Insurance coverage&#xD;
  &#xD;
                 -  obtaining of oral non opposition to research after loyal, clear and complete&#xD;
                    delivery of information&#xD;
  &#xD;
            -  Exclusion Criteria :&#xD;
  &#xD;
                 -  previous attempt of lesion resection by mucosectomy&#xD;
  &#xD;
                 -  patient with a metastatic lesion diagnosed prior to colonoscopy&#xD;
  &#xD;
                 -  patient with no colorectal lesion&#xD;
  &#xD;
                 -  adenomatous or sessile serrated polyposis syndrome&#xD;
  &#xD;
                 -  patient with bowel chronic inflammatory disease&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Hôpital Edouard Herriot</name>
        <address>
          <city>Lyon</city>
          <zip>69437</zip>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>diagnostic tool</keyword>
    <keyword>colorectal cancer</keyword>
    <keyword>therapeutic choice guidance</keyword>
    <keyword>CONECCT</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Colorectal Neoplasms</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05983315
  org study id: 69HCL21_0780
  nct id: NCT05983315
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Colorectal neoplastic lesion endoscopic characterization is a key element for histological
        predictive diagnostic value in conducting best appropriate resection choice. Six
        classifications are necessary for fully correct characterization of different colorectal
        lesions. Nonetheless, it can be tricky to use so many diagnostic tools with so many
        subcategories in the 6 existing classifications. That's why we decided to integrate all 6
        existing classification validated factors in one single chart (CONECCT chart) allowing to
        both predict histological diagnostic value and to propose the best appropriate resection
        strategy. A previous prospective and multicentre study with all French medical residents in
        gastroenterology was conducted in order to prove pedagogic interest of this diagnostic tool.
        Each student was asked to review 20 files with lesion pictures before and after lecture about
        CONECCT chart. This allowed us to prove that this diagnostic tool could significantly improve
        both histological predictive diagnostic value and therapeutic choice by French medical
        residents and gastroenterologists. Our hypothesis is that CONECCT's classification can
        improve predictive diagnostic value of colorectal lesions in over 80% of cases. Now that
        pedagogic interest of this diagnostic tool has been proven, we would like to carry out a
        larger prospective assessment in term of performance (value) of this instrument in order to
        both facilitate endoscopic characterization and allow a most appropriate diagnostic and
        therapeutic management of each colorectal lesion category.
  observational model: Cohort
  time perspective: Prospective
  measure: Correlation between endoscopic CONECCT's classification
  time frame: Time point can be reached either 2 weeks after endoscopic resection at V1 or between 2-4 months later in case of surgery at V3
  description: assessed by one of research site operators and final histology reading of neoplastic lesion by anatomopathologist:
  CONECCT 0E : neuroendocrine tumor
  CONECCT IH : hyperplastic polyp
  CONECCT IS : sessile serrated lesion with or without dysplasia
  CONECCT IIA : low or high grade adenoma
  CONECCT IIC : low or high grade adenoma or intramucosal or submucosal <1000 micron adenocarcinoma
  CONECCT III : deep invasive submucosal > 1000 microns adenocarcinoma
  arm group label: CONECCT's classification assessment
  description: Every patient who needs diagnostic colonoscopy because of digestive symptoms, medical or family history of colorectal cancer/polyps, positive colorectal screening test, acromegaly or referred by another gastroenterologist upon discovery of colorectal polyp after colonoscopy can join the cohort of this study and can get CONECCT's classification histological assessment of their neoplastic lesion by experienced endoscopist.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: France
  responsible party type: Sponsor
  mesh term: Colorectal Neoplasms