<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/NCT03042442</url>
  </required_header>
  <id_info>
    <org_study_id>PCD 769/36</org_study_id>
    <nct_id>NCT03042442</nct_id>
  </id_info>
  <brief_title>Relation Between Cachexia, Diabetes and periNeural Invasion in PANcreatic Cancer- Biomarkers Substudy</brief_title>
  <acronym>CDNPAN</acronym>
  <official_title>Relation Between Cachexia, Diabetes and periNeural Invasion in PANcreatic Cancer- Biomarkers Substudy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Iuliu Hatieganu University of Medicine and Pharmacy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Iuliu Hatieganu University of Medicine and Pharmacy</source>
  <oversight_info>
    <has_dmc>Yes</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 determine the interrelationship between cachexia, neural&#xD;
      invasion and diabetes in patients with pancreatic cancer. Thus the investigators propose to&#xD;
      identify the protein expression levels of Activin and Midkine in plasma of patients with&#xD;
      different stages of pancreatic adenocarcinoma compared with healthy patients and to evaluate&#xD;
      the possible correlation with diabetes, tumor size and tumor stage.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, the investigators will prospectively evaluate pancreatic adenocarcinoma&#xD;
      patients with or without cachexia, perineural invasion and diabetes.&#xD;
&#xD;
      Patients with pancreatic ductal adenocarcinoma, based on the results of an endoscopic&#xD;
      ultrasonography (EUS) biopsy or surgery were enrolled at the diagnosis and blood samples are&#xD;
      drawn.&#xD;
&#xD;
      Thus the investigators propose to identify the protein expression levels of Activin and&#xD;
      Midkine in plasma of patients with different stages of pancreatic adenocarcinoma compared&#xD;
      with benign pancreatic disorders and healthy patients and to evaluate the possible&#xD;
      correlation with diabetes, tumor size and tumor stage.&#xD;
&#xD;
      Furthermore, the investigators propose to identify the prognostic role of these biomarkers in&#xD;
      the development of metastasis and survival in patients with adenocarcinoma, with and without&#xD;
      diabetes and cachexia; to identify a new biomarker predictive of cachexia and eventually to&#xD;
      select patients likely to benefit from treatment with antagonists of activin (or hypoglycemic&#xD;
      treatment) and investigating the role of invasion neural in the appearance of cachexia in&#xD;
      patients with pancreatic adenocarcinoma.&#xD;
&#xD;
      Follow-up: with phone-calls on an every 6 month, for up to 2 years, retaining the following&#xD;
      data: survival, date of decease and its direct cause, the presence of tumor recurrence.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">September 30, 2018</completion_date>
  <primary_completion_date type="Actual">June 30, 2018</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of patients with loss of &gt; 5% body weight</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Using the BMI at admission and BMI at 6 months after admission</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with pain as main symptom and antialgic therapy</measure>
    <time_frame>up to 12 Months</time_frame>
    <description>At baseline, throughout and at the end of the study as assessed by Visual Analogue Scale and type of antialgic treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Quality of Life of participants (EORTC QLQ-C30 )</measure>
    <time_frame>Change from baseline at 12 months</time_frame>
    <description>At baseline, throughout and at the end of the study using EORTC QLQ-C30 questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Food intake assessment of participants using SNAQ questionnaire</measure>
    <time_frame>Change from baseline at 6 months</time_frame>
    <description>At baseline, throughout and at the end of the study using SNAQ questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessing the survival rate by phone-calls follow-up every 6 months, up to 2 years</measure>
    <time_frame>up to 2 years</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">114</enrollment>
  <condition>Pancreatic Cancer, Adult</condition>
  <condition>Cachexia</condition>
  <condition>Pain</condition>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Patients with pancreatic cancer</arm_group_label>
    <description>Patients with pancreatic ductal adenocarcinoma, based on the results of an endoscopic ultrasonography (EUS) biopsy or surgery were enrolled at the diagnosis, before any therapeutic intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>health patients (controls)</arm_group_label>
    <description>Health patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Point-of care biomarkers</intervention_name>
    <description>Point-of care biomarkers(Activin,Midkine) assessed by WB and IHC</description>
    <arm_group_label>Patients with pancreatic cancer</arm_group_label>
    <arm_group_label>health patients (controls)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Clinical, venous blood samples, pancreatic tissue</intervention_name>
    <description>Clinical evaluation, venous blood samples and pancreatic tissue needed for determining point-of-care biomarkers.</description>
    <arm_group_label>Patients with pancreatic cancer</arm_group_label>
    <arm_group_label>health patients (controls)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Follow-up</intervention_name>
    <description>Participants will be assessed (by telephone) over a period of 2 years</description>
    <arm_group_label>Patients with pancreatic cancer</arm_group_label>
    <arm_group_label>health patients (controls)</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Venous blood samples and pancreatic cancer tissue (from EUS FNA and surgery) will be&#xD;
      collected from patients with pancreatic cancer adenocarcinoma at the time of diagnosis. The&#xD;
      blood sample will be immediately prepared by centrifugation at 5000 × g for 5 min. The plasma&#xD;
      samples were stored at -80 °C until use. Tissue will be embedded in paraffin.&#xD;
&#xD;
      Point-of-care bio-markers will be assessed by using western blot analyses and&#xD;
      immunohistochemistry.&#xD;
&#xD;
      The participant will be explicitly asked for consent for storing the plasma sample.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with pancreatic ductal adenocarcinoma, based on the results of an endoscopic&#xD;
        ultrasonography (EUS) biopsy or surgery were enrolled at the diagnosis, before any&#xD;
        therapeutic intervention.&#xD;
&#xD;
        Subjects of the study group were at least 18 years old, with no previous history of any&#xD;
        other cancer in the last 5 years. Written consent was given prior to entry into the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age over 18 years old&#xD;
&#xD;
          2. EUS or surgery biopsy confirming the diagnosis of adenocarcinoma&#xD;
&#xD;
          3. Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. obvious malabsorption&#xD;
&#xD;
          2. artificial nutrition&#xD;
&#xD;
          3. hyperthyroidism&#xD;
&#xD;
          4. major depression&#xD;
&#xD;
          5. other causes of malnutrition&#xD;
&#xD;
          6. refusing to enter the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Livia Petrusel, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Iuliu Hatieganu University of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Regional Institute of Gastroenterology and Hepatology</name>
      <address>
        <city>Cluj Napoca</city>
        <state>Cluj</state>
        <zip>400192</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Romania</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>March 16, 2019</last_update_submitted>
  <last_update_submitted_qc>March 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Iuliu Hatieganu University of Medicine and Pharmacy</investigator_affiliation>
    <investigator_full_name>Livia Petrusel</investigator_full_name>
    <investigator_title>MD, PhD Student</investigator_title>
  </responsible_party>
  <keyword>pancreatic cancer</keyword>
  <keyword>cachexia</keyword>
  <keyword>perineural invasion</keyword>
  <keyword>pain</keyword>
  <keyword>diabetes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Wasting Syndrome</mesh_term>
    <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/NCT03042442
org study id: PCD 769/36
nct id: NCT03042442
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine the interrelationship between cachexia, neural
      invasion and diabetes in patients with pancreatic cancer. Thus the investigators propose to
      identify the protein expression levels of Activin and Midkine in plasma of patients with
      different stages of pancreatic adenocarcinoma compared with healthy patients and to evaluate
      the possible correlation with diabetes, tumor size and tumor stage.
In this study, the investigators will prospectively evaluate pancreatic adenocarcinoma
      patients with or without cachexia, perineural invasion and diabetes.

      Patients with pancreatic ductal adenocarcinoma, based on the results of an endoscopic
      ultrasonography (EUS) biopsy or surgery were enrolled at the diagnosis and blood samples are
      drawn.

      Thus the investigators propose to identify the protein expression levels of Activin and
      Midkine in plasma of patients with different stages of pancreatic adenocarcinoma compared
      with benign pancreatic disorders and healthy patients and to evaluate the possible
      correlation with diabetes, tumor size and tumor stage.

      Furthermore, the investigators propose to identify the prognostic role of these biomarkers in
      the development of metastasis and survival in patients with adenocarcinoma, with and without
      diabetes and cachexia; to identify a new biomarker predictive of cachexia and eventually to
      select patients likely to benefit from treatment with antagonists of activin (or hypoglycemic
      treatment) and investigating the role of invasion neural in the appearance of cachexia in
      patients with pancreatic adenocarcinoma.

      Follow-up: with phone-calls on an every 6 month, for up to 2 years, retaining the following
      data: survival, date of decease and its direct cause, the presence of tumor recurrence.
observational model: Case-Control
time perspective: Prospective
measure: Rate of patients with loss of > 5% body weight
time frame: up to 6 months
description: Using the BMI at admission and BMI at 6 months after admission
measure: Number of participants with pain as main symptom and antialgic therapy
time frame: up to 12 Months
description: At baseline, throughout and at the end of the study as assessed by Visual Analogue Scale and type of antialgic treatment
measure: Evaluation of Quality of Life of participants (EORTC QLQ-C30 )
time frame: Change from baseline at 12 months
description: At baseline, throughout and at the end of the study using EORTC QLQ-C30 questionnaire
measure: Food intake assessment of participants using SNAQ questionnaire
time frame: Change from baseline at 6 months
description: At baseline, throughout and at the end of the study using SNAQ questionnaire
measure: Assessing the survival rate by phone-calls follow-up every 6 months, up to 2 years
time frame: up to 2 years
arm group label: Patients with pancreatic cancer
description: Patients with pancreatic ductal adenocarcinoma, based on the results of an endoscopic ultrasonography (EUS) biopsy or surgery were enrolled at the diagnosis, before any therapeutic intervention.
arm group label: health patients (controls)
description: Health patients
intervention type: Diagnostic Test
intervention name: Point-of care biomarkers
description: Point-of care biomarkers(Activin,Midkine) assessed by WB and IHC
arm group label: Patients with pancreatic cancer
arm group label: health patients (controls)
intervention type: Other
intervention name: Clinical, venous blood samples, pancreatic tissue
description: Clinical evaluation, venous blood samples and pancreatic tissue needed for determining point-of-care biomarkers.
arm group label: Patients with pancreatic cancer
arm group label: health patients (controls)
intervention type: Other
intervention name: Follow-up
description: Participants will be assessed (by telephone) over a period of 2 years
arm group label: Patients with pancreatic cancer
arm group label: health patients (controls)
Venous blood samples and pancreatic cancer tissue (from EUS FNA and surgery) will be
      collected from patients with pancreatic cancer adenocarcinoma at the time of diagnosis. The
      blood sample will be immediately prepared by centrifugation at 5000 × g for 5 min. The plasma
      samples were stored at -80 °C until use. Tissue will be embedded in paraffin.

      Point-of-care bio-markers will be assessed by using western blot analyses and
      immunohistochemistry.

      The participant will be explicitly asked for consent for storing the plasma sample.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
last name: Livia Petrusel, MD, PhD
role: Principal Investigator
affiliation: Iuliu Hatieganu University of Medicine
facility: 
country: Romania
responsible party type: Principal Investigator
investigator affiliation: Iuliu Hatieganu University of Medicine and Pharmacy
investigator full name: Livia Petrusel
investigator title: MD, PhD Student
mesh term: Pancreatic Neoplasms
mesh term: Diabetes Mellitus
mesh term: Wasting Syndrome
mesh term: Cachexia
sharing ipd: No