<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/NCT04482491</url>
  </required_header>
  <id_info>
    <org_study_id>Endoscopic Characterization</org_study_id>
    <nct_id>NCT04482491</nct_id>
  </id_info>
  <brief_title>Histological Prediction and Choice of the Resection Strategy in Front of a Colorectal Lesion &gt; 2 cm: Prospective Comparison of Endoscopic Characterization, Non-targeted and Targeted Biopsies</brief_title>
  <official_title>Histological Prediction and Choice of the Resection Strategy in Front of a Colorectal Lesion &gt; 2 cm: Prospective Comparison of Endoscopic Characterization, Non-targeted and Targeted Biopsies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hôpital Edouard Herriot</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hôpital Edouard Herriot</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Colorectal cancer has become a public health priority considering its increased prevalence&#xD;
      and high mortality rate when diagnosed late. As a consequence, many countries have promoted&#xD;
      and uptaken of colorectal cancer screening programs leading to an increasing detection of&#xD;
      advanced but also superficial lesions ESGE (European Society of Gastrointestinal Endoscopy)&#xD;
      guidelines states that the majority of those colonic and rectal superficial lesions can be&#xD;
      removed in a curative way by standard polypectomy and/or by EMR (Endoscopic Mucosal&#xD;
      Resection) and that ESD (Endoscopic Submucosal Dissection) can be considered for removal of&#xD;
      colonic and rectal lesions with high suspicion of limited submucosal invasion.&#xD;
      Histologically, a resection is curative for the patient when the adenocarcinoma is&#xD;
      well-differentiated (G1/G2), with a depth of invasion ≤ sm1 (≤ 1 mm submucosal invasion),&#xD;
      with no lymphovascular invasion nor budding and with lateral and deep margins free of cancer&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">January 1, 2020</completion_date>
  <primary_completion_date type="Actual">January 1, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>correlation between the histological prediction according to the CONECCT classification, the directed biopsy, the non-directed biopsy and the final histology of the completely resected part (R0).</measure>
    <time_frame>1 Year</time_frame>
  </primary_outcome>
  <enrollment type="Actual">90</enrollment>
  <condition>Endoscopic Submucosal Dissection</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoscopic Submucosal Dissection</intervention_name>
    <description>Endoscopic Submucosal Dissection</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Hgh Risk Colorectal Cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients with colorectal lesions&gt; 2 cm because any gastroenterologist must be able to&#xD;
        resect 2 cm polyps on their own and therefore should never need to take biopsies to clarify&#xD;
        the histology before resection.&#xD;
&#xD;
        Patient consenting after information If the lesion is defined by an endoscopist as CONECCT&#xD;
        IIA, simple adenoma, the lesion will be resected by en bloc mucosectomy or piece meal&#xD;
        depending on its size (after a biopsy, secondary objective).&#xD;
&#xD;
        If the lesion is defined by an endoscopist as CONECCT IIC, adenoma at risk or superficial&#xD;
        cancer (&lt;1000µm depth), the lesion will be resected by R0 en bloc by mucosectomy or&#xD;
        dissection if the lesion is greater than 20mm (after a biopsy, secondary objective).&#xD;
&#xD;
        If the lesion is defined by an endoscopist as CONECCT III, deep adenocarcinoma (≥1000µm&#xD;
        depth), it will be sampled from the most severe part by biopsy forceps and the patient will&#xD;
        be referred to oncology or surgery according to the extension assessment .&#xD;
&#xD;
        Pathology available of endoscopic or surgical resection piece Follow-up at 6 months after&#xD;
        treatment for CONECCT IS, IIA, IIC lesions by endoscopic control and III by clinical or&#xD;
        imaging control.&#xD;
&#xD;
        .&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Metastatic lesion immediately before colonoscopy Patients under guardianship Age &lt;18&#xD;
        Pregnant woman Contraindication to colonoscopy.&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Edouard Herriot Hospital</name>
      <address>
        <city>Lyon</city>
        <state>Rhône Alpes</state>
        <zip>69473</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 18, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>July 21, 2020</last_update_submitted>
  <last_update_submitted_qc>July 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hôpital Edouard Herriot</investigator_affiliation>
    <investigator_full_name>Jean Christophe Saurin</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04482491
org study id: Endoscopic Characterization
nct id: NCT04482491
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Colorectal cancer has become a public health priority considering its increased prevalence
      and high mortality rate when diagnosed late. As a consequence, many countries have promoted
      and uptaken of colorectal cancer screening programs leading to an increasing detection of
      advanced but also superficial lesions ESGE (European Society of Gastrointestinal Endoscopy)
      guidelines states that the majority of those colonic and rectal superficial lesions can be
      removed in a curative way by standard polypectomy and/or by EMR (Endoscopic Mucosal
      Resection) and that ESD (Endoscopic Submucosal Dissection) can be considered for removal of
      colonic and rectal lesions with high suspicion of limited submucosal invasion.
      Histologically, a resection is curative for the patient when the adenocarcinoma is
      well-differentiated (G1/G2), with a depth of invasion ≤ sm1 (≤ 1 mm submucosal invasion),
      with no lymphovascular invasion nor budding and with lateral and deep margins free of cancer
observational model: Cohort
time perspective: Prospective
measure: correlation between the histological prediction according to the CONECCT classification, the directed biopsy, the non-directed biopsy and the final histology of the completely resected part (R0).
time frame: 1 Year
intervention type: Procedure
intervention name: Endoscopic Submucosal Dissection
description: Endoscopic Submucosal Dissection
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Hôpital Edouard Herriot
investigator full name: Jean Christophe Saurin
investigator title: Professor
sharing ipd: No