<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/NCT04404777</url>
  </required_header>
  <id_info>
    <org_study_id>LERIS</org_study_id>
    <nct_id>NCT04404777</nct_id>
  </id_info>
  <brief_title>Local Recurrence Due to Rectal Cancer in Sweden</brief_title>
  <acronym>LERIS</acronym>
  <official_title>Local Recurrence Due to Rectal Cancer in Sweden - the Actual Incidence, Treatment and Outcome After Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sahlgrenska University Hospital, Sweden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sahlgrenska University Hospital, Sweden</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>
      The aim of this retrospective national registry study is to validate the reporting of local&#xD;
      recurrence in the registry. Another aim is to identify preoperative risk factors for local&#xD;
      recurrence. This can in turn indicate the need for a more intense follow-up. The treatment of&#xD;
      local recurrence, including the impact of the multidisciplinary team conference (MDT) and the&#xD;
      surgical procedure and the referral pathways of local recurrences will also be determined.&#xD;
&#xD;
      We aim to evaluate treatment outcome after local recurrence for patients operated or treated&#xD;
      between 2007-2018.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 1, 2022</start_date>
  <completion_date type="Anticipated">August 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2023</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>Other</time_perspective>
  </study_design_info>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>Number of local recurrences</measure>
    <time_frame>Between 2007-2018</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>3 year survival</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage R0 resection after local recurrence</measure>
    <time_frame>1-2 months after initiated treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MDT effect on treatment of local recurrence</measure>
    <time_frame>1-3 months after diagnosis of recurrence</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">12000</enrollment>
  <condition>Rectal Neoplasms</condition>
  <arm_group>
    <arm_group_label>Patients with local recurrence</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Treatment for local recurrence with surgery or other treatments</intervention_name>
    <description>All types of treatment for local recurrence will be evaluated</description>
    <arm_group_label>Patients with local recurrence</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients treated in Sweden with a curative intent in 2007-2018 will be included. The&#xD;
        number of recurrences, patterns of recurrence and outcome after treatment will be evaluated&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Rectal cancer with a curative intent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Rectal cancer without curative intent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Dept. of Surgery, Sahlgrenska University Hospital/Ostra</name>
      <address>
        <city>Gothenburg</city>
        <zip>SE 416 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eva Angenete, MD,PhD</last_name>
      <phone>+46313438410</phone>
      <email>eva.angenete@vgregion.se</email>
    </contact>
    <contact_backup>
      <last_name>Erik Palmqvist, MD</last_name>
      <phone>+46313434000</phone>
      <email>erik.palmqvist@vgregion.se</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>May 24, 2020</study_first_submitted>
  <study_first_submitted_qc>May 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>November 4, 2022</last_update_submitted>
  <last_update_submitted_qc>November 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sahlgrenska University Hospital, Sweden</investigator_affiliation>
    <investigator_full_name>Eva Angenete</investigator_full_name>
    <investigator_title>PI</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal Neoplasms</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04404777
org study id: LERIS
nct id: NCT04404777
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this retrospective national registry study is to validate the reporting of local
      recurrence in the registry. Another aim is to identify preoperative risk factors for local
      recurrence. This can in turn indicate the need for a more intense follow-up. The treatment of
      local recurrence, including the impact of the multidisciplinary team conference (MDT) and the
      surgical procedure and the referral pathways of local recurrences will also be determined.

      We aim to evaluate treatment outcome after local recurrence for patients operated or treated
      between 2007-2018.
observational model: Cohort
time perspective: Other
measure: Number of local recurrences
time frame: Between 2007-2018
measure: 3 year survival
time frame: 3 years
measure: Percentage R0 resection after local recurrence
time frame: 1-2 months after initiated treatment
measure: MDT effect on treatment of local recurrence
time frame: 1-3 months after diagnosis of recurrence
arm group label: Patients with local recurrence
intervention type: Procedure
intervention name: Treatment for local recurrence with surgery or other treatments
description: All types of treatment for local recurrence will be evaluated
arm group label: Patients with local recurrence
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
facility: 
status: Recruiting
contact: 
contact backup: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Sahlgrenska University Hospital, Sweden
investigator full name: Eva Angenete
investigator title: PI
mesh term: Rectal Neoplasms
mesh term: Recurrence
sharing ipd: Undecided