<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/NCT03288402</url>
  </required_header>
  <id_info>
    <org_study_id>MW165915/IRAS ID 197653</org_study_id>
    <nct_id>NCT03288402</nct_id>
  </id_info>
  <brief_title>Investigation of the Effects of Diet on the Measurement of Plasma Chromogranin in NET Patients</brief_title>
  <acronym>DIB-NET</acronym>
  <official_title>Investigation of the Effects of Breakfast or Caffeine Containing Beverages on the Measurement of Plasma Chromogranin A in Patients With Gastro-entero-pancreatic Neuroendocrine Tumours (GEP-NET)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospitals Coventry and Warwickshire NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospitals Coventry and Warwickshire NHS Trust</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>
      Measurement of plasma chromogranin A remains the most commonly used biomarkers for both&#xD;
      screening and monitoring of patients with gastro-entero-pancreatic neuroendocrine tumours&#xD;
      (GEP-NET), despite several limitations that include: lack of a reference CgA standard; wide&#xD;
      variations depending on the used assay in different laboratories; and varying sensitivity&#xD;
      ranges from 60 to 90% with low specificity &lt;50%, depending on the population studied.&#xD;
&#xD;
      Surprisingly, and to the best of our knowledge, only three studies with small numbers of&#xD;
      participants have been published that have investigated possible effects of food intake on&#xD;
      the measurement of CgA. Most have been performed in healthy controls or patients on treatment&#xD;
      with proton pump inhibitors for chronic gastritis (up to n = 11 per group) but only one study&#xD;
      has investigated patients with GEP-NET, where n = 6 patients with gastric NET were included.&#xD;
&#xD;
      In this study, the investigators aim to assess the time dependent effects of normally&#xD;
      ingested diet (5-item English breakfast; or tea or coffee; or ongoing fasted state) on plasma&#xD;
      chromogranin A measurements, using timed measurements over 180 min following an &gt; 10 hours&#xD;
      overnight fast, in a randomised double-crossover design. The investigators aimed to include&#xD;
      25 - 35 patients with a histologically confirmed diagnosis of a GEP-NET of varying primary&#xD;
      tumour location, tumour stage, grade; and presence or absence of treatment with long acting&#xD;
      somatostatin analogues; as well as 10 - 15 healthy controls. In an additional small subgroup&#xD;
      of patients who are initiated on treatment with GLP-1 analogues i.e. for type 2 diabetes or&#xD;
      obesity, the investigators aim to establish whether injection of GLP-1 analogues has any&#xD;
      effects on plasma CgA measurements.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Anticipated">January 31, 2020</completion_date>
  <primary_completion_date type="Actual">August 3, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>double crossover (ongoing fasted; or caffeine containing beverages; of 5-item English breakfast)</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>changes in plasma CgA measurements related to intake of food or caffeine containing beverages, as compared to ongoing fasted state</measure>
    <time_frame>up to 180 min</time_frame>
    <description>plasma CgA 0, 30, 60, 90, 120, 150 and 180 min</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Neuroendocrine Tumors</condition>
  <arm_group>
    <arm_group_label>ongoing fasted</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ongoing fasted following 10 h overnight fast; series blood samples CgA over 180 min</description>
  </arm_group>
  <arm_group>
    <arm_group_label>intake of caffeine containing beverages</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 h overnight fast; intake of caffeine containing beverages; series blood samples CgA over 180 min</description>
  </arm_group>
  <arm_group>
    <arm_group_label>intake of 5 item English breakfast</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 h overnight fast; intake of 5-item English breakfast; series blood samples CgA over 180 min</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ongoing fasted state, intake of caffeine containing beverages or 5-item English breakfast</intervention_name>
    <description>effects of ongoing fasted state; or intake caffeine containing beverages; or 5-item English breakfast on plasma CgA measurements, in series blood tests every 30 min over 180 min</description>
    <arm_group_label>intake of 5 item English breakfast</arm_group_label>
    <arm_group_label>intake of caffeine containing beverages</arm_group_label>
    <arm_group_label>ongoing fasted</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        GEP-NET patients:&#xD;
&#xD;
          -  Confirmed diagnosis of NET&#xD;
&#xD;
          -  Aged 18 or over&#xD;
&#xD;
          -  Able to provide written informed consent&#xD;
&#xD;
          -  Able to commit to 3 visits within a 4 week period&#xD;
&#xD;
          -  Able to fast overnight&#xD;
&#xD;
          -  Able to adequately read/write/speak English&#xD;
&#xD;
        CONTROLS:&#xD;
&#xD;
          -  No known diagnosis of NET&#xD;
&#xD;
          -  Aged 18 or over&#xD;
&#xD;
          -  Able to provide written informed consent&#xD;
&#xD;
          -  Able to commit to 3 visits within a 4 week period&#xD;
&#xD;
          -  Able to fast overnight&#xD;
&#xD;
          -  Able to adequately read/write/speak English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - GEP-NET patients&#xD;
&#xD;
          -  No confirmed diagnosis of a NET&#xD;
&#xD;
          -  Under the age of 18&#xD;
&#xD;
          -  Unable to provide written informed consent&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Any patients who are un well on the day of their routine appointment&#xD;
&#xD;
          -  Unable to fast overnight&#xD;
&#xD;
          -  Unable to adequately read/write/speak English&#xD;
&#xD;
        CONTROLS&#xD;
&#xD;
          -  Confirmed diagnosis of NET&#xD;
&#xD;
          -  Under the age of 18&#xD;
&#xD;
          -  Unable to provide written informed consent&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Any patients who are un well on the day&#xD;
&#xD;
          -  Unable to fast overnight&#xD;
&#xD;
          -  Unable to adequately read/write/speak English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martin O Weickert, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>The ARDEN NET Centre, ENETS CoE</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Megan Symington, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>The ARDEN NET Centre, ENETS CoE</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Helen Robbins, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>The ARDEN NET Centre, ENETS CoE</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The ARDEN NET Centre, ENETS Centre of Excellence</name>
      <address>
        <city>Coventry</city>
        <zip>CV2 2DX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/?term=weickert+mo</url>
    <description>publication list MO Weickert</description>
  </link>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>March 5, 2018</last_update_submitted>
  <last_update_submitted_qc>March 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2018</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>Neuroendocrine Tumors</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Caffeine</mesh_term>
  </intervention_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/NCT03288402
org study id: MW165915/IRAS ID 197653
nct id: NCT03288402
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Measurement of plasma chromogranin A remains the most commonly used biomarkers for both
      screening and monitoring of patients with gastro-entero-pancreatic neuroendocrine tumours
      (GEP-NET), despite several limitations that include: lack of a reference CgA standard; wide
      variations depending on the used assay in different laboratories; and varying sensitivity
      ranges from 60 to 90% with low specificity <50%, depending on the population studied.

      Surprisingly, and to the best of our knowledge, only three studies with small numbers of
      participants have been published that have investigated possible effects of food intake on
      the measurement of CgA. Most have been performed in healthy controls or patients on treatment
      with proton pump inhibitors for chronic gastritis (up to n = 11 per group) but only one study
      has investigated patients with GEP-NET, where n = 6 patients with gastric NET were included.

      In this study, the investigators aim to assess the time dependent effects of normally
      ingested diet (5-item English breakfast; or tea or coffee; or ongoing fasted state) on plasma
      chromogranin A measurements, using timed measurements over 180 min following an > 10 hours
      overnight fast, in a randomised double-crossover design. The investigators aimed to include
      25 - 35 patients with a histologically confirmed diagnosis of a GEP-NET of varying primary
      tumour location, tumour stage, grade; and presence or absence of treatment with long acting
      somatostatin analogues; as well as 10 - 15 healthy controls. In an additional small subgroup
      of patients who are initiated on treatment with GLP-1 analogues i.e. for type 2 diabetes or
      obesity, the investigators aim to establish whether injection of GLP-1 analogues has any
      effects on plasma CgA measurements.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: double crossover (ongoing fasted; or caffeine containing beverages; of 5-item English breakfast)
primary purpose: Screening
masking: None (Open Label)
measure: changes in plasma CgA measurements related to intake of food or caffeine containing beverages, as compared to ongoing fasted state
time frame: up to 180 min
description: plasma CgA 0, 30, 60, 90, 120, 150 and 180 min
arm group label: ongoing fasted
arm group type: Experimental
description: ongoing fasted following 10 h overnight fast; series blood samples CgA over 180 min
arm group label: intake of caffeine containing beverages
arm group type: Experimental
description: 10 h overnight fast; intake of caffeine containing beverages; series blood samples CgA over 180 min
arm group label: intake of 5 item English breakfast
arm group type: Experimental
description: 10 h overnight fast; intake of 5-item English breakfast; series blood samples CgA over 180 min
intervention type: Other
intervention name: ongoing fasted state, intake of caffeine containing beverages or 5-item English breakfast
description: effects of ongoing fasted state; or intake caffeine containing beverages; or 5-item English breakfast on plasma CgA measurements, in series blood tests every 30 min over 180 min
arm group label: intake of 5 item English breakfast
arm group label: intake of caffeine containing beverages
arm group label: ongoing fasted
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Martin O Weickert, Professor
role: Study Chair
affiliation: The ARDEN NET Centre, ENETS CoE
last name: Megan Symington, Dr
role: Principal Investigator
affiliation: The ARDEN NET Centre, ENETS CoE
last name: Helen Robbins, Dr
role: Principal Investigator
affiliation: The ARDEN NET Centre, ENETS CoE
facility: 
country: United Kingdom
url: https://www.ncbi.nlm.nih.gov/pubmed/?term=weickert+mo
description: publication list MO Weickert
responsible party type: Sponsor
mesh term: Neuroendocrine Tumors
mesh term: Caffeine
sharing ipd: No