<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/NCT04430231</url>
  </required_header>
  <id_info>
    <org_study_id>2019/285</org_study_id>
    <nct_id>NCT04430231</nct_id>
  </id_info>
  <brief_title>Does Delaying Curative Surgery for Colorectal Cancer Influence Long-term Disease Free Survival.</brief_title>
  <official_title>Does Delaying Curative Surgery for Colorectal Cancer Influence Long-term Disease Free Survival.: A COHORT STUDY</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundación para la Investigación del Hospital Clínico de Valencia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundación para la Investigación del Hospital Clínico de Valencia</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 work is an original clinical research article describing the relationship between wait&#xD;
      list tome for colorectal cancer patients and long-term survival. These findings are&#xD;
      particularly relevant for management of surgical wait lists during crisis such as the&#xD;
      Covid-19 pandemic. The lack of a relationship between wait list time and disease free&#xD;
      survival and tendency for improved survival in the 4-6 week imply some colorectal cancer&#xD;
      operations can be safely delayed during times of limited resources.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background Surgical wait list time is a major problem in many health-care systems and its&#xD;
      influence on survival is unclear. The aim of this study is to assess the impact of the wait&#xD;
      list time on long term disease-free survival in patients scheduled for colorectal cancer&#xD;
      resection.&#xD;
&#xD;
      Materials and Methods A prospective, single center study was carried out in patients with&#xD;
      stage I-III colorectal cancer scheduled for surgery between 2012-2017 at a Colorectal Surgery&#xD;
      Unit of a tertiary care center. Wait list time was defined as the time from completion of&#xD;
      diagnostic workup and definitive surgery and divided into 2-week intervals from 2 to 6 weeks.&#xD;
      The outcome variables were 2- and 5-year disease free survival. Screening for disease&#xD;
      progression was with carcinoembryonic antigen levels and chest/abdominal computed tomography&#xD;
      scan. Data was collected prospectively and subsequently analyzed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2012</start_date>
  <completion_date type="Actual">April 1, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Disease-free overall survival</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">602</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Wait list time 0-2 weeks</arm_group_label>
    <description>Wait list time 0-2 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait list time 2-4 weeks</arm_group_label>
    <description>Wait list time 2-4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait list time 4-6 weeks</arm_group_label>
    <description>Wait list time 4-6 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait list time &gt; 6 weeks</arm_group_label>
    <description>Wait list time &gt; 6 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Wait list time</intervention_name>
    <arm_group_label>Wait list time 0-2 weeks</arm_group_label>
    <arm_group_label>Wait list time 2-4 weeks</arm_group_label>
    <arm_group_label>Wait list time 4-6 weeks</arm_group_label>
    <arm_group_label>Wait list time &gt; 6 weeks</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who had American Joint Committee on Cancer (AJCC) stage I through III confirmed&#xD;
        adenocarcinomas were selected, with &quot;colon&quot; or &quot;upper rectum&quot; as their primary site of&#xD;
        malignancy according to International Classification of Diseases for Oncology, Third&#xD;
        Edition topography code.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Joint Committee on Cancer (AJCC) stage I through III confirmed&#xD;
             adenocarcinomas&#xD;
&#xD;
          -  With &quot;colon&quot; or &quot;upper rectum&quot; as their primary site of malignancy according to&#xD;
             International Classification of Diseases for Oncology, Third Edition topography code.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Emergency surgery,&#xD;
&#xD;
          -  More than one primary site,&#xD;
&#xD;
          -  Synchronous metastasis or peritoneal carcinomatosis at the time of surgery&#xD;
&#xD;
          -  If they received neoadjuvant chemoradiotherapy&#xD;
&#xD;
          -  If they had a local transanal excision.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>June 12, 2020</last_update_submitted>
  <last_update_submitted_qc>June 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fundación para la Investigación del Hospital Clínico de Valencia</investigator_affiliation>
    <investigator_full_name>Stephanie Garcia Botello</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</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/NCT04430231
org study id: 2019/285
nct id: NCT04430231
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This work is an original clinical research article describing the relationship between wait
      list tome for colorectal cancer patients and long-term survival. These findings are
      particularly relevant for management of surgical wait lists during crisis such as the
      Covid-19 pandemic. The lack of a relationship between wait list time and disease free
      survival and tendency for improved survival in the 4-6 week imply some colorectal cancer
      operations can be safely delayed during times of limited resources.
Background Surgical wait list time is a major problem in many health-care systems and its
      influence on survival is unclear. The aim of this study is to assess the impact of the wait
      list time on long term disease-free survival in patients scheduled for colorectal cancer
      resection.

      Materials and Methods A prospective, single center study was carried out in patients with
      stage I-III colorectal cancer scheduled for surgery between 2012-2017 at a Colorectal Surgery
      Unit of a tertiary care center. Wait list time was defined as the time from completion of
      diagnostic workup and definitive surgery and divided into 2-week intervals from 2 to 6 weeks.
      The outcome variables were 2- and 5-year disease free survival. Screening for disease
      progression was with carcinoembryonic antigen levels and chest/abdominal computed tomography
      scan. Data was collected prospectively and subsequently analyzed.
observational model: Cohort
time perspective: Prospective
measure: Disease-free overall survival
time frame: 5 years
arm group label: Wait list time 0-2 weeks
description: Wait list time 0-2 weeks
arm group label: Wait list time 2-4 weeks
description: Wait list time 2-4 weeks
arm group label: Wait list time 4-6 weeks
description: Wait list time 4-6 weeks
arm group label: Wait list time > 6 weeks
description: Wait list time > 6 weeks
intervention type: Other
intervention name: Wait list time
arm group label: Wait list time 0-2 weeks
arm group label: Wait list time 2-4 weeks
arm group label: Wait list time 4-6 weeks
arm group label: Wait list time > 6 weeks
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
responsible party type: Principal Investigator
investigator affiliation: Fundación para la Investigación del Hospital Clínico de Valencia
investigator full name: Stephanie Garcia Botello
investigator title: Clinical Professor
mesh term: Colorectal Neoplasms
sharing ipd: Undecided