xml: <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/NCT06016829</url>
    </required_header>
    <id_info>
      <org_study_id>GO 21/499</org_study_id>
      <nct_id>NCT06016829</nct_id>
    </id_info>
    <brief_title>Preoperative Nutritional Status and Postoperative Outcomes in Colorectal Cancer</brief_title>
    <official_title>The Effect of Preoperative Nutritional Status, Dietary Inflammatory Index and Systemic Inflammatory Response on Postoperative Outcomes in Colorectal Cancer.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hacettepe University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Ankara City Hospital Bilkent</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Hacettepe University</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 was to evaluate the effect of preoperative nutritional status, dietary&#xD;
        inflammatory index, and systemic inflammatory response on postoperative outcomes. The study&#xD;
        will include 120 colorectal cancer patients who are scheduled for surgical treatment.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A questionnaire form containing general information, dietary habits, and food consumption&#xD;
        records will be applied by the researcher in the preoperative period to the patients who&#xD;
        volunteered to participate in the study. Body composition will be taken by bioelectrical&#xD;
        impedance analysis method, and waist circumference, hip circumference, mid upper arm&#xD;
        circumference, and calf circumference will be measured with a non-stretchable tape measure.&#xD;
        Hand grip strength will be taken with a digital hand dynamometer. The nutritional status of&#xD;
        patients will be assessed using the criteria of the Nutritional Risk Screening 2002&#xD;
        (NRS-2002), the Global Leadership Initiative on Malnutrition (GLIM) and the Patient Generated&#xD;
        Subjective Global Assessment (PG-SGA). For body composition analysis, computed tomography&#xD;
        images, known as the gold standard, will be used in cancer patients. Computed tomography&#xD;
        images of the patients will be obtained from hospital records at L3 lumbar vertebra level.&#xD;
        The software program ImageJ developed by the US National Institute of Health will be used to&#xD;
        calculate the visceral fat area (cm2), subcutaneous fat area (cm2), and skeletal muscle area&#xD;
        (cm2) from the recorded images.&#xD;
  &#xD;
        Preoperative biochemical parameters will be obtained from hospital records. The systemic&#xD;
        inflammatory response will be determined by the Prognostic Nutritional Index, Neutrophil&#xD;
        Lymphocyte Ratio, and Delta Neutrophil Index. The inflammatory load of the diet will be&#xD;
        calculated using the Dietary Inflammatory Index. The quality of life of patients will be&#xD;
        assessed using cancer-specific scales developed by the European Organisation for Research and&#xD;
        Treatment of Cancer (EORTC) during the preoperative and postoperative periods. These scales&#xD;
        are EORTC-QLQ-C30 for general quality of life and EORTC-QLQ-CR29 for colorectal&#xD;
        cancer-specific quality of life.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 25, 2021</start_date>
    <completion_date type="Anticipated">March 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Postoperative complications</measure>
      <time_frame>within 30 days after surgery</time_frame>
      <description>Complications graded by Clavien-Dindo Complication Classification System</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Postoperative quality of life</measure>
      <time_frame>within 45 days after surgery</time_frame>
      <description>Quality of life will be evaluated by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30).All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>EORTC-QLQ-CR29</measure>
      <time_frame>within 45 days after surgery</time_frame>
      <description>European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer 29 (EORTC-QLQ-CR29) is a supplementary questionnaire module to be employed in conjunction with the Quality of Life Questionnaire Core 30 (QLQ-C30). All of the scales and single-item measures range in score from 0 to 100. A high score for the functional scale and functional single-items represents a high level of functioning, whereas a high score for the symptom scales and symptom single-items represents a high level of symptomatology or problem.</description>
    </primary_outcome>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Colorectal Cancer</condition>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Nutrition Risk Screening 2002 (NRS-2002)</intervention_name>
      <description>Nutritional status assessment tool</description>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Global Leadership Initiative on Malnutrition (GLIM)</intervention_name>
      <description>Nutritional status assessment tool</description>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Patient Generated Subjective Global Assessment (PG-SGA)</intervention_name>
      <description>Nutritional status assessment tool</description>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Measurement of body composition with computed tomography (CT)</intervention_name>
      <description>The cross section of the third lumbar vertebrae in the CT scan images of the patients will be analyzed for assessment of body composition parameters including skeletal muscle area (SMA), visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT)</description>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Dietary inflammatory index (DII)</intervention_name>
      <description>The Dietary Inflammatory Index (DII) is a scoring algorithm that indicates the inflammatory potential of the diet.</description>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)</intervention_name>
      <description>Quality of life assessment tool</description>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer 29 (EORTC-QLQ-CR29)</intervention_name>
      <description>Quality of life assessment tool</description>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Prognostic Nutritional Index (PNI)</intervention_name>
      <description>Prognostic Nutritional Index is diagnostic test based on serum albumin level and total lymphocyte count</description>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Neutrophil-Lymphocyte Ratio (NLR)</intervention_name>
      <description>The neutrophil-to-lymphocyte ratio (NLR) is calculated as the simple ratio between neutrophil and lymphocyte counts.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients aged 18 years and older who have undergone surgical treatment for a diagnosis of&#xD;
          colorectal cancer&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Having been diagnosed with colorectal cancer and having surgical treatment planned&#xD;
  &#xD;
            -  Being 18 years of age or older&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Having received chemotherapy or radiotherapy&#xD;
  &#xD;
            -  Currently undergoing corticosteroid or hormone treatment.&#xD;
  &#xD;
            -  Presence of distant metastases.&#xD;
  &#xD;
            -  Presence of any malignancy other than colorectal cancer.&#xD;
  &#xD;
            -  Presence of autoimmune disease.&#xD;
  &#xD;
            -  Presence of ongoing infectious disease.&#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_official>
      <last_name>Tuba N Yildiz Kopuz</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hacettepe University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Mehmet Fisunoglu</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hacettepe University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Tuba N Yildiz Kopuz</last_name>
      <phone>+903123051094</phone>
      <email>dyttubanuryildiz@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mehmet Fisunoglu</last_name>
      <phone>+903123051094</phone>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Hacettepe University</name>
        <address>
          <city>Ankara</city>
          <zip>06100</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Tuba N Yildiz Kopuz</last_name>
      </contact>
      <contact_backup>
        <last_name>Mehmet Fisunoglu, PhD</last_name>
      </contact_backup>
      <investigator>
        <last_name>Tuba N Yildiz Kopuz</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Mehmet Fisunoglu</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Ankara City Hospital Bilkent</name>
        <address>
          <city>Ankara</city>
          <zip>06800</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sadettin Er, MD</last_name>
      </contact>
      <investigator>
        <last_name>Sadettin Er, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Furkan H Yildiz, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hacettepe University</investigator_affiliation>
      <investigator_full_name>Tuba Nur Yildiz Kopuz</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>colorectal cancer</keyword>
    <keyword>nutritional status</keyword>
    <keyword>body composition</keyword>
    <keyword>quality of life</keyword>
    <keyword>postoperative complication</keyword>
    <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>
  
  
text: 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/NCT06016829
  org study id: GO 21/499
  nct id: NCT06016829
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study was to evaluate the effect of preoperative nutritional status, dietary
        inflammatory index, and systemic inflammatory response on postoperative outcomes. The study
        will include 120 colorectal cancer patients who are scheduled for surgical treatment.
  A questionnaire form containing general information, dietary habits, and food consumption
        records will be applied by the researcher in the preoperative period to the patients who
        volunteered to participate in the study. Body composition will be taken by bioelectrical
        impedance analysis method, and waist circumference, hip circumference, mid upper arm
        circumference, and calf circumference will be measured with a non-stretchable tape measure.
        Hand grip strength will be taken with a digital hand dynamometer. The nutritional status of
        patients will be assessed using the criteria of the Nutritional Risk Screening 2002
        (NRS-2002), the Global Leadership Initiative on Malnutrition (GLIM) and the Patient Generated
        Subjective Global Assessment (PG-SGA). For body composition analysis, computed tomography
        images, known as the gold standard, will be used in cancer patients. Computed tomography
        images of the patients will be obtained from hospital records at L3 lumbar vertebra level.
        The software program ImageJ developed by the US National Institute of Health will be used to
        calculate the visceral fat area (cm2), subcutaneous fat area (cm2), and skeletal muscle area
        (cm2) from the recorded images.
  
        Preoperative biochemical parameters will be obtained from hospital records. The systemic
        inflammatory response will be determined by the Prognostic Nutritional Index, Neutrophil
        Lymphocyte Ratio, and Delta Neutrophil Index. The inflammatory load of the diet will be
        calculated using the Dietary Inflammatory Index. The quality of life of patients will be
        assessed using cancer-specific scales developed by the European Organisation for Research and
        Treatment of Cancer (EORTC) during the preoperative and postoperative periods. These scales
        are EORTC-QLQ-C30 for general quality of life and EORTC-QLQ-CR29 for colorectal
        cancer-specific quality of life.
  observational model: Case-Only
  time perspective: Prospective
  measure: Postoperative complications
  time frame: within 30 days after surgery
  description: Complications graded by Clavien-Dindo Complication Classification System
  measure: Postoperative quality of life
  time frame: within 45 days after surgery
  description: Quality of life will be evaluated by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30).All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
  measure: EORTC-QLQ-CR29
  time frame: within 45 days after surgery
  description: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer 29 (EORTC-QLQ-CR29) is a supplementary questionnaire module to be employed in conjunction with the Quality of Life Questionnaire Core 30 (QLQ-C30). All of the scales and single-item measures range in score from 0 to 100. A high score for the functional scale and functional single-items represents a high level of functioning, whereas a high score for the symptom scales and symptom single-items represents a high level of symptomatology or problem.
  intervention type: Diagnostic Test
  intervention name: Nutrition Risk Screening 2002 (NRS-2002)
  description: Nutritional status assessment tool
  intervention type: Diagnostic Test
  intervention name: Global Leadership Initiative on Malnutrition (GLIM)
  description: Nutritional status assessment tool
  intervention type: Diagnostic Test
  intervention name: Patient Generated Subjective Global Assessment (PG-SGA)
  description: Nutritional status assessment tool
  intervention type: Other
  intervention name: Measurement of body composition with computed tomography (CT)
  description: The cross section of the third lumbar vertebrae in the CT scan images of the patients will be analyzed for assessment of body composition parameters including skeletal muscle area (SMA), visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT)
  intervention type: Diagnostic Test
  intervention name: Dietary inflammatory index (DII)
  description: The Dietary Inflammatory Index (DII) is a scoring algorithm that indicates the inflammatory potential of the diet.
  intervention type: Diagnostic Test
  intervention name: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)
  description: Quality of life assessment tool
  intervention type: Diagnostic Test
  intervention name: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer 29 (EORTC-QLQ-CR29)
  description: Quality of life assessment tool
  intervention type: Diagnostic Test
  intervention name: Prognostic Nutritional Index (PNI)
  description: Prognostic Nutritional Index is diagnostic test based on serum albumin level and total lymphocyte count
  intervention type: Diagnostic Test
  intervention name: Neutrophil-Lymphocyte Ratio (NLR)
  description: The neutrophil-to-lymphocyte ratio (NLR) is calculated as the simple ratio between neutrophil and lymphocyte counts.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Tuba N Yildiz Kopuz
  role: Principal Investigator
  affiliation: Hacettepe University
  last name: Mehmet Fisunoglu
  role: Principal Investigator
  affiliation: Hacettepe University
  last name: Tuba N Yildiz Kopuz
  phone: +903123051094
  email: dyttubanuryildiz@gmail.com
  last name: Mehmet Fisunoglu
  phone: +903123051094
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Hacettepe University
  investigator full name: Tuba Nur Yildiz Kopuz
  investigator title: Principal Investigator
  mesh term: Colorectal Neoplasms