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/NCT06033976</url>
    </required_header>
    <id_info>
      <org_study_id>ESDREG</org_study_id>
      <nct_id>NCT06033976</nct_id>
    </id_info>
    <brief_title>Endoscopic Submucosal Dissection Registry</brief_title>
    <acronym>ESDREG</acronym>
    <official_title>Endoscopic Submucosal Dissection Patients Registry in &quot;Agrippa Ionescu&quot; Hospital, Bucharest, Romania</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Carol Davila University of Medicine and Pharmacy</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Carol Davila University of Medicine and Pharmacy</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>
        This is a patient registry for all cases of pre-neoplastic or early neoplastic digestive&#xD;
        tract lesions treated with curative intention by endoscopic submucosal dissection (ESD)&#xD;
        technique.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Cases will be registered one by one in an electronic record, with the consent of the patient&#xD;
        and respecting all legal requirements.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2021</start_date>
    <completion_date type="Anticipated">January 2031</completion_date>
    <primary_completion_date type="Anticipated">January 2031</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>10 Years</target_duration>
    <primary_outcome>
      <measure>Rate of curative resection</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Rate of R0 resection</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
    </secondary_outcome>
    <other_outcome>
      <measure>Rate of perforation</measure>
      <time_frame>30 days</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Rate of delayed bleeding</measure>
      <time_frame>30 days</time_frame>
    </other_outcome>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Neoplasm, Stomach</condition>
    <condition>Neoplasm, Colorectal</condition>
    <condition>Neoplasm, Esophagus</condition>
    <condition>Neoplasm, Duodenal</condition>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Endoscopic submucosal dissection (ESD)</intervention_name>
      <description>Endoscopic injection of fluid into the gastrointestinal submucosal space followed by endoscopic knife dissection around and under the lesion so as to remove the lesion specimen in one piece with lesion free resection margins.</description>
      <other_name>ESD</other_name>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Resected specimens of the gastrointestinal tract, fixed in formalin&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Patients diagnosed at or referred to Gastroenterology Clinic, University of Medicine and&#xD;
          Pharmacy, &quot;Agrippa Ionescu&quot; Hospital, Bucharest, Romania&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  epithelial pre-neoplastic (eg. adenoma, dysplasia) lesion on the esophageal, gastric,&#xD;
               duodenal or colorectal mucosa&#xD;
  &#xD;
            -  non-epithelial (eg. neuroendocrine tumor) lesion on the esophageal, gastric, duodenal&#xD;
               or colorectal mucosa&#xD;
  &#xD;
            -  age &gt; 18 years old&#xD;
  &#xD;
            -  informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  age &lt; 18 years old&#xD;
  &#xD;
            -  no informed consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mihai L Ciocirlan, Associate Professor</last_name>
      <role>Principal Investigator</role>
      <affiliation>Carol Davila University of Medicine and Pharmacy</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ciocirlan L Mihai, Associate Professor</last_name>
      <phone>0040722322625</phone>
      <email>mihai.ciocirlan@umfcd.ro</email>
    </overall_contact>
    <location>
      <facility>
        <name>&quot;Agrippa Ionescu&quot; Hospital</name>
        <address>
          <city>Bucharest</city>
          <country>Romania</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mihai L Ciocirlan</last_name>
        <phone>0040722322625</phone>
        <email>mihai.ciocirlan@umfcd.ro</email>
      </contact>
    </location>
    <location_countries>
      <country>Romania</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 3, 2023</study_first_submitted>
    <study_first_submitted_qc>September 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 10, 2023</last_update_submitted>
    <last_update_submitted_qc>September 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Carol Davila University of Medicine and Pharmacy</investigator_affiliation>
      <investigator_full_name>Mihai Ciocirlan</investigator_full_name>
      <investigator_title>Clinical Professor (Associate Professor)</investigator_title>
    </responsible_party>
    <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>Stomach Neoplasms</mesh_term>
      <mesh_term>Esophageal Neoplasms</mesh_term>
      <mesh_term>Duodenal 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>
  
  
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/NCT06033976
  org study id: ESDREG
  nct id: NCT06033976
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a patient registry for all cases of pre-neoplastic or early neoplastic digestive
        tract lesions treated with curative intention by endoscopic submucosal dissection (ESD)
        technique.
  Cases will be registered one by one in an electronic record, with the consent of the patient
        and respecting all legal requirements.
  observational model: Cohort
  time perspective: Prospective
  measure: Rate of curative resection
  time frame: through study completion, an average of 1 year
  measure: Rate of R0 resection
  time frame: through study completion, an average of 1 year
  measure: Rate of perforation
  time frame: 30 days
  measure: Rate of delayed bleeding
  time frame: 30 days
  intervention type: Procedure
  intervention name: Endoscopic submucosal dissection (ESD)
  description: Endoscopic injection of fluid into the gastrointestinal submucosal space followed by endoscopic knife dissection around and under the lesion so as to remove the lesion specimen in one piece with lesion free resection margins.
  other name: ESD
  Resected specimens of the gastrointestinal tract, fixed in formalin
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: No
  last name: Mihai L Ciocirlan, Associate Professor
  role: Principal Investigator
  affiliation: Carol Davila University of Medicine and Pharmacy
  last name: Ciocirlan L Mihai, Associate Professor
  phone: 0040722322625
  email: mihai.ciocirlan@umfcd.ro
  facility: 
  status: Recruiting
  contact: 
  country: Romania
  responsible party type: Principal Investigator
  investigator affiliation: Carol Davila University of Medicine and Pharmacy
  investigator full name: Mihai Ciocirlan
  investigator title: Clinical Professor (Associate Professor)
  mesh term: Neoplasms
  mesh term: Colorectal Neoplasms
  mesh term: Stomach Neoplasms
  mesh term: Esophageal Neoplasms
  mesh term: Duodenal Neoplasms
  sharing ipd: No