<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/NCT04422002</url>
  </required_header>
  <id_info>
    <org_study_id>CSPT-ONCOFRAGIL.2020-1</org_study_id>
    <nct_id>NCT04422002</nct_id>
  </id_info>
  <brief_title>Survival Analysis of Frail Patients With Localised Colorectal Cancer</brief_title>
  <official_title>Survival Analysis of Frail Patients With Localised Colorectal Cancer: Multicentre Observational Study, Comparing Surgical vs Palliative Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Corporacion Parc Tauli</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Corporacion Parc Tauli</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 purpose of this study is to analyse the survival of frail patients with localized&#xD;
      colorectal cancer who undergo surgical treatment in comparison with those with palliative&#xD;
      treatment&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with localized colorectal cancer will be visited by a colorectal surgeon who will&#xD;
      explain the disease and the surgical treatment. In this visit the patient will be screened&#xD;
      for frailty and asked for informed consent. Patients who meet the eligibility criteria will&#xD;
      be sent to the internal medicine consultant to frailty evaluation, risk assessment and&#xD;
      counselling in order to help patient decision process.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 1, 2019</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2021</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>Survival</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Surgical complications</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Colorectal Cancer</condition>
  <condition>Surgery</condition>
  <condition>Frailty</condition>
  <arm_group>
    <arm_group_label>Surgical treatment</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Palliative treatment</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adults with a recent diagnostic of localised colorectal cancer and a positive frailty&#xD;
        screening&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Localised colorectal cancer&#xD;
&#xD;
          -  Positive frailty screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#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>Ana Granados-Maturano</last_name>
    <phone>0034646339823</phone>
    <email>ana.granados@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sheila Serra-Pla</last_name>
    <phone>0034670390120</phone>
    <email>sserra@tauli.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Corporacio Parc Tauli</name>
      <address>
        <city>Sabadell</city>
        <state>Barcelona</state>
        <zip>08208</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ana Granados-Maturano</last_name>
      <phone>0034646339823</phone>
      <email>ana.granados@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Sheila Serra-Pla</last_name>
      <phone>0034670390120</phone>
      <email>sserra@tauli.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 4, 2020</last_update_submitted>
  <last_update_submitted_qc>June 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Corporacion Parc Tauli</investigator_affiliation>
    <investigator_full_name>Ana Granados-Maturano</investigator_full_name>
    <investigator_title>Dr</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>Frailty</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/NCT04422002
org study id: CSPT-ONCOFRAGIL.2020-1
nct id: NCT04422002
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to analyse the survival of frail patients with localized
      colorectal cancer who undergo surgical treatment in comparison with those with palliative
      treatment
Patients with localized colorectal cancer will be visited by a colorectal surgeon who will
      explain the disease and the surgical treatment. In this visit the patient will be screened
      for frailty and asked for informed consent. Patients who meet the eligibility criteria will
      be sent to the internal medicine consultant to frailty evaluation, risk assessment and
      counselling in order to help patient decision process.
observational model: Cohort
time perspective: Prospective
measure: Survival
time frame: 1 year
measure: Surgical complications
time frame: 30 days
arm group label: Surgical treatment
arm group label: Palliative treatment
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ana Granados-Maturano
phone: 0034646339823
email: ana.granados@gmail.com
last name: Sheila Serra-Pla
phone: 0034670390120
email: sserra@tauli.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Corporacion Parc Tauli
investigator full name: Ana Granados-Maturano
investigator title: Dr
mesh term: Colorectal Neoplasms
mesh term: Frailty
sharing ipd: Undecided