<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/NCT03789136</url>
  </required_header>
  <id_info>
    <org_study_id>NL58188.081.16</org_study_id>
    <nct_id>NCT03789136</nct_id>
  </id_info>
  <brief_title>The Effect of Colon Cancer on Muscle Gene Expression, Body Composition, Muscle Function, and Muscle Metabolism</brief_title>
  <acronym>COMUNEX</acronym>
  <official_title>The Effect of Colon Cancer on Muscle Gene Expression, Body Composition, Muscle Function, and Muscle Metabolism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wageningen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Gelderse Vallei Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Top Institute Food and Nutrition</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Wageningen University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rationale: Cancer cachexia is a complex metabolic syndrome characterized by clinically&#xD;
      relevant loss of muscle mass with or without loss of fat mass. To determine how treatment&#xD;
      methods can be most effective, full insight in changes in gene expression, body composition,&#xD;
      muscle function and muscle metabolism are of great importance.&#xD;
&#xD;
      Objective: Main aim of the study is to investigate the differences in gene expression, body&#xD;
      composition, muscle function and muscle metabolism in colon cancer patients compared to&#xD;
      controls.&#xD;
&#xD;
      Study design: Observational study Study population: 40 colon cancer patients undergoing a&#xD;
      tumor resection (30 primary tumor and 10 liver metastases) and 15 control patients undergoing&#xD;
      an inguinal hernia repair (♂, 10) or an abdominal hysterectomy (♀, 5).&#xD;
&#xD;
      Main study parameters/endpoints: Primary study parameter will be gene expression&#xD;
      (transcriptomic and polymerase chain reaction analyses of muscle biopsies). Secondary&#xD;
      parameters will be body composition (determined in available CT scans and bio impedance&#xD;
      analysis and with DEXA), muscle function parameters (grip and knee flexion/extension strength&#xD;
      and measured in a biopsy), metabolic markers (measured in fat and muscle biopsies),&#xD;
      biochemical markers (measured in blood/serum) and gene expression of fat biopsies.&#xD;
&#xD;
      Nature and extent of the burden and risks associated with participation, benefit and group&#xD;
      relatedness: The investigators expect no additional risk for the subjects due to the proposed&#xD;
      measurements. Biopsies will be taken during the planned operation and therefore is not&#xD;
      expected to cause a significant increase in burden for the patient. All other measurements&#xD;
      are non-invasive, observational measurements with no risk of any harmful side effects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 24, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Muscle gene expression</measure>
    <time_frame>Biopsy during surgery</time_frame>
    <description>Muscle gene expression measured by microarray in a muscle biopsy taken from the rectus abdominis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body composition</measure>
    <time_frame>Before surgery</time_frame>
    <description>Measured using single slice staining of CT scan made for diagnostic purposes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle function</measure>
    <time_frame>Before surgery</time_frame>
    <description>Measured using hand-grip strength</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle protein metabolism</measure>
    <time_frame>Biopsy during surgery</time_frame>
    <description>Measured in a muscle biopsy taken from the rectus abdominis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adipose tissue gene expression</measure>
    <time_frame>Biopsy during surgery</time_frame>
    <description>Adipose tissue gene expression measured using PCR or micro-array in abdominal and subcutaneous fat</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cytokine parameters in the blood</measure>
    <time_frame>Blood taken prior to surgery</time_frame>
    <description>Blood plasma cytokine levels measured using multiplex or similar technique</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Micro-nutrient parameters in the blood</measure>
    <time_frame>Blood taken prior to surgery</time_frame>
    <description>Micro-nutrient levels in the blood measured using LCMS, ELISA or similar techniques</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cholesterol levels in the blood</measure>
    <time_frame>Blood taken prior to surgery</time_frame>
    <description>Cholesterol levels in the blood measured by GCMS</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">55</enrollment>
  <condition>Cachexia; Cancer</condition>
  <arm_group>
    <arm_group_label>Primary colon cancer</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Liver metastases</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Inguinal hernia (control)</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Abdominal hysterectomy (control)</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Not applicable, observational study</intervention_name>
    <description>Not applicable, observational study</description>
    <arm_group_label>Abdominal hysterectomy (control)</arm_group_label>
    <arm_group_label>Inguinal hernia (control)</arm_group_label>
    <arm_group_label>Liver metastases</arm_group_label>
    <arm_group_label>Primary colon cancer</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        40 colon cancer (CC) patients (♀ and ♂) undergoing primary tumor resection operation (30&#xD;
        patients) or liver metastases surgery (10 patients) and 15 control patients undergoing an&#xD;
        inguinal hernia repair (♂, 10) or an abdominal hysterectomy (♀, 5) will be included in the&#xD;
        study. Since the investigators do not know the number of patients in the colon cancer group&#xD;
        willing to cooperate in the study, the investigators decided to take 5 patients of each&#xD;
        control group (50% men and women). Note: during the study the investigators see more men&#xD;
        than women joining the study so therefore the investigators raised the number of male&#xD;
        controls to 10.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  CC patients:&#xD;
&#xD;
        In order to be eligible to participate in this study, a subject must meet all of the&#xD;
        following inclusion criteria:&#xD;
&#xD;
          -  Diagnosed with primary colon cancer (30) or liver metastases due to colon cancer(10)&#xD;
&#xD;
          -  Eligible for a primary tumor or liver metastases resection procedure&#xD;
&#xD;
               -  Controls:&#xD;
&#xD;
          -  Eligible for an inguinal hernia repair (♂, 10) or an abdominal hysterectomy (♀, 5)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  CC patients:&#xD;
&#xD;
        A potential subject who meets any of the following criteria will be excluded from&#xD;
        participation in this study:&#xD;
&#xD;
          -  Having had chemotherapy or an operational procedure of the abdomen in the past 6&#xD;
             months&#xD;
&#xD;
          -  Suffering from malabsorption&#xD;
&#xD;
               -  Controls:&#xD;
&#xD;
          -  Having had treatment for previous or current tumors&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>For the control group the investigators include men with inguinal hernia and women eligible for abdominal hysterectomy.</gender_description>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Klaske van Norren, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wageningen University and Research</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Klaske van Norren, PhD</last_name>
    <phone>+31317485790</phone>
    <email>klaske.vannorrren@wur.nl</email>
  </overall_contact>
  <location>
    <facility>
      <name>Gelderse Vallei Hospital</name>
      <address>
        <city>Ede</city>
        <state>Gelderland</state>
        <zip>6716 RP</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dik Snijdelaar, md</last_name>
      <email>snijdelaarD@zgv.nl</email>
    </contact>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>December 7, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <last_update_submitted>June 28, 2021</last_update_submitted>
  <last_update_submitted_qc>June 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cachexia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03789136
org study id: NL58188.081.16
nct id: NCT03789136
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Rationale: Cancer cachexia is a complex metabolic syndrome characterized by clinically
      relevant loss of muscle mass with or without loss of fat mass. To determine how treatment
      methods can be most effective, full insight in changes in gene expression, body composition,
      muscle function and muscle metabolism are of great importance.

      Objective: Main aim of the study is to investigate the differences in gene expression, body
      composition, muscle function and muscle metabolism in colon cancer patients compared to
      controls.

      Study design: Observational study Study population: 40 colon cancer patients undergoing a
      tumor resection (30 primary tumor and 10 liver metastases) and 15 control patients undergoing
      an inguinal hernia repair (♂, 10) or an abdominal hysterectomy (♀, 5).

      Main study parameters/endpoints: Primary study parameter will be gene expression
      (transcriptomic and polymerase chain reaction analyses of muscle biopsies). Secondary
      parameters will be body composition (determined in available CT scans and bio impedance
      analysis and with DEXA), muscle function parameters (grip and knee flexion/extension strength
      and measured in a biopsy), metabolic markers (measured in fat and muscle biopsies),
      biochemical markers (measured in blood/serum) and gene expression of fat biopsies.

      Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness: The investigators expect no additional risk for the subjects due to the proposed
      measurements. Biopsies will be taken during the planned operation and therefore is not
      expected to cause a significant increase in burden for the patient. All other measurements
      are non-invasive, observational measurements with no risk of any harmful side effects.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Muscle gene expression
time frame: Biopsy during surgery
description: Muscle gene expression measured by microarray in a muscle biopsy taken from the rectus abdominis
measure: Body composition
time frame: Before surgery
description: Measured using single slice staining of CT scan made for diagnostic purposes.
measure: Muscle function
time frame: Before surgery
description: Measured using hand-grip strength
measure: Muscle protein metabolism
time frame: Biopsy during surgery
description: Measured in a muscle biopsy taken from the rectus abdominis
measure: Adipose tissue gene expression
time frame: Biopsy during surgery
description: Adipose tissue gene expression measured using PCR or micro-array in abdominal and subcutaneous fat
measure: Cytokine parameters in the blood
time frame: Blood taken prior to surgery
description: Blood plasma cytokine levels measured using multiplex or similar technique
measure: Micro-nutrient parameters in the blood
time frame: Blood taken prior to surgery
description: Micro-nutrient levels in the blood measured using LCMS, ELISA or similar techniques
measure: Cholesterol levels in the blood
time frame: Blood taken prior to surgery
description: Cholesterol levels in the blood measured by GCMS
arm group label: Primary colon cancer
arm group label: Liver metastases
arm group label: Inguinal hernia (control)
arm group label: Abdominal hysterectomy (control)
intervention type: Other
intervention name: Not applicable, observational study
description: Not applicable, observational study
arm group label: Abdominal hysterectomy (control)
arm group label: Inguinal hernia (control)
arm group label: Liver metastases
arm group label: Primary colon cancer
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
gender based: Yes
gender description: For the control group the investigators include men with inguinal hernia and women eligible for abdominal hysterectomy.
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Klaske van Norren, PhD
role: Principal Investigator
affiliation: Wageningen University and Research
last name: Klaske van Norren, PhD
phone: +31317485790
email: klaske.vannorrren@wur.nl
facility: 
status: Recruiting
contact: 
country: Netherlands
responsible party type: Sponsor
mesh term: Cachexia
sharing ipd: No