<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/NCT03836131</url>
  </required_header>
  <id_info>
    <org_study_id>767</org_study_id>
    <nct_id>NCT03836131</nct_id>
  </id_info>
  <brief_title>Rate of Cancer of Granular Mixed Laterally Spreading Tumors (GM-LST)</brief_title>
  <acronym>LST GM</acronym>
  <official_title>Rate of Cancer of Granular Mixed Laterally Spreading Tumors (GM-LST): A Restrospective Multicentric Analysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituto Clinico Humanitas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istituto Clinico Humanitas</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 cancer (CRC) is the third most common cancer in men and the second in women&#xD;
      worldwide, with 1.65 million new cases and almost 835,000 deaths in 2015. CRC is still a&#xD;
      major cause of mortality associated with cancer, although the wide spread of the screening&#xD;
      program has led to a reduction in the mortality rate compared to the last decades.&#xD;
&#xD;
      CRCs derive from precancerous lesions that may be polypoid or non-polypoid according to the&#xD;
      Paris classification. Thus, resection in an early stage could led to a CRC mortality&#xD;
      reduction.&#xD;
&#xD;
      Laterally spreading tumors (LST) are non-polypoid lesions of at least 1 cm in diameter that&#xD;
      have lateral growth rather than upward or downward growth.&#xD;
&#xD;
      The prevalence of LSTs ranges from 1 to 6% of all colorectal lesions. LSTs can be divided&#xD;
      into two groups: granular LSTs, which include homogeneous and granular mixed forms and&#xD;
      non-granular (NG) LSTs, which include pseudo-depressed and flat-elevated forms.&#xD;
&#xD;
      Histologically, 90% of LSTs are adenomas and having a low incidence of invasive neoplasia,&#xD;
      these lesions can be removed endoscopically.&#xD;
&#xD;
      However, as evidenced by a recent meta-analysis published by Bogie Roel MM et al on&#xD;
      Endoscopy, the type of LST and the distal or proximal colonic localization could represent&#xD;
      predictors of submucosal invasion and could simplify the therapeutic decision for the removal&#xD;
      of these lesions. GM-LSTs and pseudo-depressed NG-LSTs predominantly localize in the distal&#xD;
      portion of the colon and have a submucosal invasion rate of 10,5% and 31,6% respectively.&#xD;
&#xD;
      LSTs can be removed both through endoscopic mucosal resection (EMR) and endoscopic submucosal&#xD;
      dissection (ESD). The main limitation of EMR is that large lesions require a piecemeal&#xD;
      approach, resulting in a non-optimal histological evaluation and a high risk of recurrence.&#xD;
      ESD instead allows a higher rate of en bloc resections, thus resulting more curative and&#xD;
      reducing the risk of having partial and incomplete resections, which can lead to disease&#xD;
      recurrence/non curative resection.&#xD;
&#xD;
      LST-GM are characterized by the presence of a granular appearance with a main nodule and&#xD;
      represent approximately 1/4 of the LSTs. There are no guidelines indicating the proper&#xD;
      resective technique of these lesions.&#xD;
&#xD;
      The European Society of Gastrointestinal Endoscopy (ESGE) suggests to consider ESD for the&#xD;
      removal of colorectal lesions that are &gt; 20 mm in size, with a depressed and irregular&#xD;
      morphology or a non-granular surface pattern, as these lesions have a high probability of&#xD;
      having a limited submucosal invasion. Moreover ESD can be used to treat lesions that cannot&#xD;
      be completely removed with standard polypectomy or EMR.&#xD;
&#xD;
      The investigators propose to perform a multicenter retrospective observational study to&#xD;
      define the percentage of cancer in patients with GM-LSTs treated with endoscopic resection in&#xD;
      order to evaluate the correlation between pre-resection and post-resection characteristics,&#xD;
      defining the best therapeutic approach (en bloc or piecemeal) and avoiding incomplete&#xD;
      endoscopic resections or unnecessary surgical procedures.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 31, 2018</start_date>
  <completion_date type="Actual">January 31, 2020</completion_date>
  <primary_completion_date type="Actual">January 31, 2020</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The percentage of cancer in patients with GM-LSTs treated with endoscopic resection.</measure>
    <time_frame>12 Months</time_frame>
  </primary_outcome>
  <enrollment type="Actual">2000</enrollment>
  <condition>Colorectal Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        This is a multicenter retrospective observational study. All consecutive patients with&#xD;
        GM-LST, who underwent endoscopic resection from, will be enrolled in the study.&#xD;
&#xD;
        For each procedure LST size, nodule size, location, type of technique used for removal&#xD;
        (EMR, ESD, hybrid ESD), type of removal (piecemeal or en bloc), histological examination,&#xD;
        possible surgical intervention (and attached histological examination of the operative&#xD;
        piece) and possible relapses will be reported.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  LST-GM defined according to Paris classification&#xD;
&#xD;
          -  Agree to receive follow up phone calls&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of familial adenomatous polyposis or inflammatory bowel diseases&#xD;
&#xD;
          -  Deep submucosal invasion diagnosed by distorted pit pattern (Kudo's type V)&#xD;
&#xD;
          -  Poor general clinical condition (American Society of Anesthesiologists score ≥3)&#xD;
&#xD;
          -  Coagulation disorders&#xD;
&#xD;
          -  Pregnancy and breastfeeding&#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>Humanitas Research Hospital</name>
      <address>
        <city>Milano</city>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Humanitas Research Hospital</name>
      <address>
        <city>Rozzano</city>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>February 8, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>February 11, 2020</last_update_submitted>
  <last_update_submitted_qc>February 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>


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/NCT03836131
org study id: 767
nct id: NCT03836131
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Colorectal cancer (CRC) is the third most common cancer in men and the second in women
      worldwide, with 1.65 million new cases and almost 835,000 deaths in 2015. CRC is still a
      major cause of mortality associated with cancer, although the wide spread of the screening
      program has led to a reduction in the mortality rate compared to the last decades.

      CRCs derive from precancerous lesions that may be polypoid or non-polypoid according to the
      Paris classification. Thus, resection in an early stage could led to a CRC mortality
      reduction.

      Laterally spreading tumors (LST) are non-polypoid lesions of at least 1 cm in diameter that
      have lateral growth rather than upward or downward growth.

      The prevalence of LSTs ranges from 1 to 6% of all colorectal lesions. LSTs can be divided
      into two groups: granular LSTs, which include homogeneous and granular mixed forms and
      non-granular (NG) LSTs, which include pseudo-depressed and flat-elevated forms.

      Histologically, 90% of LSTs are adenomas and having a low incidence of invasive neoplasia,
      these lesions can be removed endoscopically.

      However, as evidenced by a recent meta-analysis published by Bogie Roel MM et al on
      Endoscopy, the type of LST and the distal or proximal colonic localization could represent
      predictors of submucosal invasion and could simplify the therapeutic decision for the removal
      of these lesions. GM-LSTs and pseudo-depressed NG-LSTs predominantly localize in the distal
      portion of the colon and have a submucosal invasion rate of 10,5% and 31,6% respectively.

      LSTs can be removed both through endoscopic mucosal resection (EMR) and endoscopic submucosal
      dissection (ESD). The main limitation of EMR is that large lesions require a piecemeal
      approach, resulting in a non-optimal histological evaluation and a high risk of recurrence.
      ESD instead allows a higher rate of en bloc resections, thus resulting more curative and
      reducing the risk of having partial and incomplete resections, which can lead to disease
      recurrence/non curative resection.

      LST-GM are characterized by the presence of a granular appearance with a main nodule and
      represent approximately 1/4 of the LSTs. There are no guidelines indicating the proper
      resective technique of these lesions.

      The European Society of Gastrointestinal Endoscopy (ESGE) suggests to consider ESD for the
      removal of colorectal lesions that are > 20 mm in size, with a depressed and irregular
      morphology or a non-granular surface pattern, as these lesions have a high probability of
      having a limited submucosal invasion. Moreover ESD can be used to treat lesions that cannot
      be completely removed with standard polypectomy or EMR.

      The investigators propose to perform a multicenter retrospective observational study to
      define the percentage of cancer in patients with GM-LSTs treated with endoscopic resection in
      order to evaluate the correlation between pre-resection and post-resection characteristics,
      defining the best therapeutic approach (en bloc or piecemeal) and avoiding incomplete
      endoscopic resections or unnecessary surgical procedures.
observational model: Cohort
time perspective: Retrospective
measure: The percentage of cancer in patients with GM-LSTs treated with endoscopic resection.
time frame: 12 Months
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Colorectal Neoplasms