<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/NCT04484311</url>
  </required_header>
  <id_info>
    <org_study_id>Non-Curative ESDs Registry</org_study_id>
    <nct_id>NCT04484311</nct_id>
  </id_info>
  <brief_title>Non-curative ESDs: Assessing the Rates and Risk Factors for Residual Neoplasia</brief_title>
  <acronym>NC-ESD</acronym>
  <official_title>Multi-center Survey on Non-curative ESDs: Assessing the Rates and Risk Factors for Residual Neoplasia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade do Porto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade do Porto</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>
      Short and long outcomes of ESD are well described, particularly in Eastern series. However,&#xD;
      the outcome of non-curative ESDs is scarcely reported in the west (particularly among&#xD;
      non-gastric or submucosal lesions). Therefore, the aim of this project is to describe the&#xD;
      European experience with non-curative ESDs, analysing all the consecutive ESDs performed in&#xD;
      several reference centers, assessing the presence of residual lesion in the endoscopic&#xD;
      follow-up or in the surgical specimen.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 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>Residual neoplasia</measure>
    <time_frame>2010-2020</time_frame>
    <description>Presence of residual neoplasia after non-curative ESD</description>
  </primary_outcome>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Gastric Neoplasm</condition>
  <condition>Esophageal Neoplasms</condition>
  <condition>Colorectal Neoplasms</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All patients submitted to ESD due to neoplastic lesions of the gastrointestinal tract.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients submitted to ESD due to neoplastic lesions of the gastrointestinal tract&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients without endoscopic follow-up or surgery will be excluded from the analysis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>João Santos-Antunes</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gastrointestinal Department, Centro Hospitalar S. João, Porto, Portugal</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Guilherme Macedo, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Gastrointestinal Department, Centro Hospitalar S. João, Porto, Portugal</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>João Santos-Antunes, MD, MSc</last_name>
    <phone>+351917490406</phone>
    <email>joao.claudio.antunes@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Guilherme Macedo, MD, PhD</last_name>
    <email>guilhermemacedo59@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital S. João</name>
      <address>
        <city>Porto</city>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>João Antunes</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>September 21, 2020</last_update_submitted>
  <last_update_submitted_qc>September 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Endoscopic therapy</keyword>
  <keyword>Endoscopic submucosal dissection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Esophageal Neoplasms</mesh_term>
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <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/NCT04484311
org study id: Non-Curative ESDs Registry
nct id: NCT04484311
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Short and long outcomes of ESD are well described, particularly in Eastern series. However,
      the outcome of non-curative ESDs is scarcely reported in the west (particularly among
      non-gastric or submucosal lesions). Therefore, the aim of this project is to describe the
      European experience with non-curative ESDs, analysing all the consecutive ESDs performed in
      several reference centers, assessing the presence of residual lesion in the endoscopic
      follow-up or in the surgical specimen.
observational model: Cohort
time perspective: Retrospective
measure: Residual neoplasia
time frame: 2010-2020
description: Presence of residual neoplasia after non-curative ESD
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: João Santos-Antunes
role: Principal Investigator
affiliation: Gastrointestinal Department, Centro Hospitalar S. João, Porto, Portugal
last name: Guilherme Macedo, MD, PhD
role: Study Director
affiliation: Gastrointestinal Department, Centro Hospitalar S. João, Porto, Portugal
last name: João Santos-Antunes, MD, MSc
phone: +351917490406
email: joao.claudio.antunes@gmail.com
last name: Guilherme Macedo, MD, PhD
email: guilhermemacedo59@gmail.com
facility: 
status: Recruiting
contact: 
country: Portugal
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Colorectal Neoplasms
mesh term: Esophageal Neoplasms
mesh term: Stomach Neoplasms
sharing ipd: No