<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/NCT04443816</url>
  </required_header>
  <id_info>
    <org_study_id>NL6152310017</org_study_id>
    <nct_id>NCT04443816</nct_id>
  </id_info>
  <brief_title>Advanced Geriatric Evaluation and Quality of Life in Colorectal Cancer Surgery</brief_title>
  <acronym>AGE CRC</acronym>
  <official_title>Advanced Geriatric Evaluation in Predicting Health Related Quality of Life in Patients With Colorectal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Antonius Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Antonius Hospital</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>
      Colorectal cancer (CRC) disproportionately affects patients aged 70 years and older. Surgery&#xD;
      is the main treatment modality for CRC, but is associated with increased risk of&#xD;
      postoperative morbidity, disability and loss of health related quality of life (HRQL).Frailty&#xD;
      is an age related state of functional decline and considered to be an important risk factor&#xD;
      for adverse outcome in geriatric oncology.Risk models for adverse outcome may be used for&#xD;
      treatment decisions in the elderly, but are often not designed to predict patient related&#xD;
      outcome measures and do not include frailty characteristics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Multicentre, prospective, observational cohort study with a follow up time of one year. After&#xD;
      initial diagnosis of CRC subjects will be screened for frailty using validated&#xD;
      questionnaires, physical tests and non-invasive measurements. Frailty characteristics and&#xD;
      HRQL are determined by Geriatric 8 (G8), Hospital Anxiety and Depression Scale(HADS),&#xD;
      Euroqol- 5 dimensional (EQ-5D), Lawton Instrumental Activity of Daily Living scale(IADL),&#xD;
      Mini Nutrition Assessment (MNA), 6 Item Cognitive Impairment Test (6-CIT), Identification of&#xD;
      Seniors At Risk - Hospitalized Patients(ISAR-HP) and the EORTC-QLQ-C30/CR29 (HRQL in CRC&#xD;
      patients). Physical tests include the Timed to Get Up (TUG) test and the hand grip strength&#xD;
      test. Furthermore, the non-invasive measurements consist of a sarcopenia analysis using an&#xD;
      existing CT/MRI scan and measurement of Advanced Glycation Endproducts (AGE reader).&#xD;
&#xD;
      Additional patients characteristics including medication use, medical history, tumor&#xD;
      characteristics, neoadjuvant therapy and laboratory results of preoperative routine blood&#xD;
      sampling will be collected. At three, six and twelve months after diagnosis, EORTC&#xD;
      QLQ-C30/EORTC QLQ-CR29 and EQ-5D questionnaires are used to determine HRQL and disability&#xD;
      free survival.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">July 6, 2021</completion_date>
  <primary_completion_date type="Actual">July 6, 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>Loss of health related quality of life (HRQL)</measure>
    <time_frame>12 months</time_frame>
    <description>Change in EORTC QLQ-C30</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Loss of health related quality of life (HRQL)</measure>
    <time_frame>3 months</time_frame>
    <description>Change in EORTC QLQ-C30</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative complications</measure>
    <time_frame>30 days</time_frame>
    <description>Complication after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disability</measure>
    <time_frame>12 months</time_frame>
    <description>EQ-5D</description>
  </secondary_outcome>
  <enrollment type="Actual">273</enrollment>
  <condition>Colorectal Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        aged ≥ 70 years with a new diagnosis of non-metastatic CRC&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 70 years&#xD;
&#xD;
          -  Histologically proven non-metastatic colorectal cancer&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  - Emergency surgical procedures&#xD;
&#xD;
          -  Insufficient understanding of the Dutch language&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Meander medical center</name>
      <address>
        <city>Amersfoort</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tergooi hospital</name>
      <address>
        <city>Hilversum</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Antonius Hospital</name>
      <address>
        <city>Nieuwegein</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rivierenland ziekenhuis</name>
      <address>
        <city>Tiel</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diakonessenhuis</name>
      <address>
        <city>Utrecht</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMCU</name>
      <address>
        <city>Utrecht</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>September 24, 2021</last_update_submitted>
  <last_update_submitted_qc>September 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Antonius Hospital</investigator_affiliation>
    <investigator_full_name>dr. P. Noordzij</investigator_full_name>
    <investigator_title>Principal Investigator</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>
  <!-- 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/NCT04443816
org study id: NL6152310017
nct id: NCT04443816
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Colorectal cancer (CRC) disproportionately affects patients aged 70 years and older. Surgery
      is the main treatment modality for CRC, but is associated with increased risk of
      postoperative morbidity, disability and loss of health related quality of life (HRQL).Frailty
      is an age related state of functional decline and considered to be an important risk factor
      for adverse outcome in geriatric oncology.Risk models for adverse outcome may be used for
      treatment decisions in the elderly, but are often not designed to predict patient related
      outcome measures and do not include frailty characteristics.
Multicentre, prospective, observational cohort study with a follow up time of one year. After
      initial diagnosis of CRC subjects will be screened for frailty using validated
      questionnaires, physical tests and non-invasive measurements. Frailty characteristics and
      HRQL are determined by Geriatric 8 (G8), Hospital Anxiety and Depression Scale(HADS),
      Euroqol- 5 dimensional (EQ-5D), Lawton Instrumental Activity of Daily Living scale(IADL),
      Mini Nutrition Assessment (MNA), 6 Item Cognitive Impairment Test (6-CIT), Identification of
      Seniors At Risk - Hospitalized Patients(ISAR-HP) and the EORTC-QLQ-C30/CR29 (HRQL in CRC
      patients). Physical tests include the Timed to Get Up (TUG) test and the hand grip strength
      test. Furthermore, the non-invasive measurements consist of a sarcopenia analysis using an
      existing CT/MRI scan and measurement of Advanced Glycation Endproducts (AGE reader).

      Additional patients characteristics including medication use, medical history, tumor
      characteristics, neoadjuvant therapy and laboratory results of preoperative routine blood
      sampling will be collected. At three, six and twelve months after diagnosis, EORTC
      QLQ-C30/EORTC QLQ-CR29 and EQ-5D questionnaires are used to determine HRQL and disability
      free survival.
observational model: Cohort
time perspective: Prospective
measure: Loss of health related quality of life (HRQL)
time frame: 12 months
description: Change in EORTC QLQ-C30
measure: Loss of health related quality of life (HRQL)
time frame: 3 months
description: Change in EORTC QLQ-C30
measure: Postoperative complications
time frame: 30 days
description: Complication after surgery
measure: Disability
time frame: 12 months
description: EQ-5D
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: St. Antonius Hospital
investigator full name: dr. P. Noordzij
investigator title: Principal Investigator
mesh term: Colorectal Neoplasms