<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/NCT04406662</url>
  </required_header>
  <id_info>
    <org_study_id>AC19154</org_study_id>
    <nct_id>NCT04406662</nct_id>
  </id_info>
  <brief_title>Routine Evaluation of People Living With Cancer</brief_title>
  <acronym>REVOLUTION</acronym>
  <official_title>Routine Evaluation of People Living With Cancer - Body Composition, Physical Function, Systemic Inflammatory Response, Quality of Life and Symptoms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Edinburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>NHS Lothian</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Edinburgh</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>
      People with incurable cancer often have complex individual needs, however there are several&#xD;
      common themes encountered when considering this group.&#xD;
&#xD;
      As cancer progresses there are series of interactions between the tumour and the patient,&#xD;
      producing both local and systemic effects. This altered state of illness can have multiple&#xD;
      ill effects including weight loss, fatigue, increased symptom burden and reduction in&#xD;
      physical function which all contribute to a reduced quality of life.&#xD;
&#xD;
      These areas are often studied in isolation, giving an incomplete picture. A detailed,&#xD;
      holistic characterisation of this group of people does not exist.&#xD;
&#xD;
      A robust characterisation of people with incurable cancer will allow identification and&#xD;
      prioritisation of future research and has the potential to inform new therapeutics and&#xD;
      provide justification for treatments.&#xD;
&#xD;
      This study aims to collect information about symptoms and quality of life, weight loss and&#xD;
      body composition, physical activity and the body's immune response to cancer.&#xD;
&#xD;
      Participants with incurable cancer will be recruited to the study from oncology and&#xD;
      palliative medicine services in the UK. Participants will answer questionnaires about quality&#xD;
      of life and symptoms, have bloods taken for inflammatory marker and cytokine analysis and&#xD;
      have their body composition measured by a variety of methods.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 15, 2020</start_date>
  <completion_date type="Anticipated">August 8, 2029</completion_date>
  <primary_completion_date type="Anticipated">August 8, 2029</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Association between inflammatory cytokines and clinical parameters in incurable cancer</measure>
    <time_frame>2 years</time_frame>
    <description>Correlation of serum levels of inflammatory cytokines with clinical parameters including skeletal muscle mass, symptom based scores and physical activity as measured by actigraphy.</description>
  </primary_outcome>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Cachexia; Cancer</condition>
  <condition>Advanced Cancer</condition>
  <condition>Quality of Life</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples - samples sent for routine inflammatory markers, plasma retained for analysis&#xD;
      of cytokine levels and stored in a biobank for use in future ethically approved studies&#xD;
      including potential genetic DNA analysis.&#xD;
&#xD;
      Archival tissue specimens (including fresh frozen and/or formalin fixed paraffin embedded&#xD;
      biopsy/surgical specimens) that are no longer required by the local pathologist for&#xD;
      diagnostic purposes, or are stored as part of ethically approved tissue collection/research&#xD;
      studies, may be requested from patients in the course of establishing the biobank for further&#xD;
      analysis in future studies&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        People living with incurable cancer recruited from oncology and palliative care services in&#xD;
        the UK&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with incurable cancer (metastatic cancer (Clinical, histological, cytological&#xD;
             or radiological evidence) or receiving anti-cancer therapy with palliative intent).&#xD;
&#xD;
          -  Aged 18-years and over&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any concomitant medical or psychiatric problems which, in the opinion of the&#xD;
             investigator, would increase the risk of complication for the participant and/or&#xD;
             investigator.&#xD;
&#xD;
          -  Participants will not be able to take part in bio-impedance analysis if they have a&#xD;
             pacemaker or implantable cardiac defibrillator.&#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>Barry JA Laird, MBCHB MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St Columba's Hospice/ University of Edinburgh</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Barry JA Laird, MBCHB MD</last_name>
    <phone>01316518611</phone>
    <email>barry.laird@ed.ac.uk</email>
  </overall_contact>
  <location>
    <facility>
      <name>St Columba's Hospice</name>
      <address>
        <city>Edinburgh</city>
        <zip>EH53RW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rebekah Patton</last_name>
      <phone>01315511381</phone>
      <email>rpatton@stcolumbashospice.org.uk</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>March 13, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>April 27, 2021</last_update_submitted>
  <last_update_submitted_qc>April 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cancer</keyword>
  <keyword>advanced cancer</keyword>
  <keyword>incurable cancer</keyword>
  <keyword>body composition</keyword>
  <keyword>physical function</keyword>
  <keyword>symptoms</keyword>
  <keyword>cachexia</keyword>
  <keyword>quality of life</keyword>
  <keyword>systemic inflammatory response</keyword>
  <keyword>palliative medicine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wasting Syndrome</mesh_term>
    <mesh_term>Cachexia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT04406662
org study id: AC19154
nct id: NCT04406662
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
People with incurable cancer often have complex individual needs, however there are several
      common themes encountered when considering this group.

      As cancer progresses there are series of interactions between the tumour and the patient,
      producing both local and systemic effects. This altered state of illness can have multiple
      ill effects including weight loss, fatigue, increased symptom burden and reduction in
      physical function which all contribute to a reduced quality of life.

      These areas are often studied in isolation, giving an incomplete picture. A detailed,
      holistic characterisation of this group of people does not exist.

      A robust characterisation of people with incurable cancer will allow identification and
      prioritisation of future research and has the potential to inform new therapeutics and
      provide justification for treatments.

      This study aims to collect information about symptoms and quality of life, weight loss and
      body composition, physical activity and the body's immune response to cancer.

      Participants with incurable cancer will be recruited to the study from oncology and
      palliative medicine services in the UK. Participants will answer questionnaires about quality
      of life and symptoms, have bloods taken for inflammatory marker and cytokine analysis and
      have their body composition measured by a variety of methods.
observational model: Other
time perspective: Prospective
measure: Association between inflammatory cytokines and clinical parameters in incurable cancer
time frame: 2 years
description: Correlation of serum levels of inflammatory cytokines with clinical parameters including skeletal muscle mass, symptom based scores and physical activity as measured by actigraphy.
Blood samples - samples sent for routine inflammatory markers, plasma retained for analysis
      of cytokine levels and stored in a biobank for use in future ethically approved studies
      including potential genetic DNA analysis.

      Archival tissue specimens (including fresh frozen and/or formalin fixed paraffin embedded
      biopsy/surgical specimens) that are no longer required by the local pathologist for
      diagnostic purposes, or are stored as part of ethically approved tissue collection/research
      studies, may be requested from patients in the course of establishing the biobank for further
      analysis in future studies
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Barry JA Laird, MBCHB MD
role: Principal Investigator
affiliation: St Columba's Hospice/ University of Edinburgh
last name: Barry JA Laird, MBCHB MD
phone: 01316518611
email: barry.laird@ed.ac.uk
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Wasting Syndrome
mesh term: Cachexia
sharing ipd: Yes