<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/NCT04406974</url>
  </required_header>
  <id_info>
    <org_study_id>Lokalrecidiv i VGR</org_study_id>
    <nct_id>NCT04406974</nct_id>
  </id_info>
  <brief_title>Locally Advanced Colorectal Cancer and Local Recurrences in Västra Götaland</brief_title>
  <official_title>Locally Advanced Colorectal Cancer and Recurrence After Colorectal Cancer in Region Västra Götaland</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 study is to review the treatment strategies of locally advanced colorectal&#xD;
      cancer and locally recurrent rectal cancer in Västra Götaland during 1995-2016. The aim is to&#xD;
      evaluate time trends and outcome both related to morbidity and cancer specific survival, we&#xD;
      will also evaluate the results after advanced reconstruction. The study will identify the&#xD;
      population using the Swedish ColoRectal Cancer Registry and then the individual patient&#xD;
      charts will be reviewed. The data will be collected in a clinical record form covering&#xD;
      demography (age, sex, co-morbidity, BMI and diagnoses) as well as treatments strategy,&#xD;
      surgical procedures, re-operations, complications, readmissions, hospital stay, stoma&#xD;
      formation etc.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Anticipated">December 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2022</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>Survival after local recurrence</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Risk factors for local recurrence</measure>
    <time_frame>Preoperative data, about 1 month prior surgery</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Complications after urinary reconstruction surgery for locally advanced cancer</measure>
    <time_frame>90 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient experiences after local recurrence</measure>
    <time_frame>3 years postopeartively after local recurrence</time_frame>
    <description>Indepth interviews with patients with local recurrence</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">4000</enrollment>
  <condition>Colorectal Neoplasms</condition>
  <arm_group>
    <arm_group_label>Patients with local recurrence</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients with advanced colorectal cancer</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgery or treatment for local recurrence</intervention_name>
    <description>Surgery or treatment for local recurrence</description>
    <arm_group_label>Patients with advanced colorectal cancer</arm_group_label>
    <arm_group_label>Patients with local recurrence</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgery for advanced colorectal cancer</intervention_name>
    <description>Surgery for advanced colorectal cancer</description>
    <arm_group_label>Patients with advanced colorectal cancer</arm_group_label>
    <arm_group_label>Patients with local recurrence</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients treated in Region Västra Götaland 1995-2018 for colorectal cancer will be&#xD;
        identified using the local Swedish Colorectal Cancer Registry. Further selection will&#xD;
        depend on the primary outcome in substudies.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Locally advanced rectal cancer&#xD;
&#xD;
          -  Local recurrence for colorectal cancer&#xD;
&#xD;
          -  Curative treatment for colorectal cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#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_contact>
    <last_name>Eva Angenete, MD. PhD</last_name>
    <phone>0760514441</phone>
    <email>eva.angenete@vgregion.se</email>
  </overall_contact>
  <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>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>April 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 29, 2020</study_first_posted>
  <last_update_submitted>April 16, 2022</last_update_submitted>
  <last_update_submitted_qc>April 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 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>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal 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/NCT04406974
org study id: Lokalrecidiv i VGR
nct id: NCT04406974
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to review the treatment strategies of locally advanced colorectal
      cancer and locally recurrent rectal cancer in Västra Götaland during 1995-2016. The aim is to
      evaluate time trends and outcome both related to morbidity and cancer specific survival, we
      will also evaluate the results after advanced reconstruction. The study will identify the
      population using the Swedish ColoRectal Cancer Registry and then the individual patient
      charts will be reviewed. The data will be collected in a clinical record form covering
      demography (age, sex, co-morbidity, BMI and diagnoses) as well as treatments strategy,
      surgical procedures, re-operations, complications, readmissions, hospital stay, stoma
      formation etc.
observational model: Cohort
time perspective: Retrospective
measure: Survival after local recurrence
time frame: 3 years
measure: Risk factors for local recurrence
time frame: Preoperative data, about 1 month prior surgery
measure: Complications after urinary reconstruction surgery for locally advanced cancer
time frame: 90 days
measure: Patient experiences after local recurrence
time frame: 3 years postopeartively after local recurrence
description: Indepth interviews with patients with local recurrence
arm group label: Patients with local recurrence
arm group label: Patients with advanced colorectal cancer
intervention type: Procedure
intervention name: Surgery or treatment for local recurrence
description: Surgery or treatment for local recurrence
arm group label: Patients with advanced colorectal cancer
arm group label: Patients with local recurrence
intervention type: Procedure
intervention name: Surgery for advanced colorectal cancer
description: Surgery for advanced colorectal cancer
arm group label: Patients with advanced colorectal cancer
arm group label: Patients with local recurrence
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eva Angenete, MD. PhD
phone: 0760514441
email: eva.angenete@vgregion.se
facility: 
status: Recruiting
contact: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Sahlgrenska University Hospital, Sweden
investigator full name: Eva Angenete
investigator title: Professor
mesh term: Colorectal Neoplasms
mesh term: Recurrence
sharing ipd: Undecided