<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/NCT03832062</url>
  </required_header>
  <id_info>
    <org_study_id>CCR 4838</org_study_id>
    <nct_id>NCT03832062</nct_id>
  </id_info>
  <brief_title>HoLST-F: A Feasibility Study</brief_title>
  <official_title>Homogenization of Leftover Surgical Tissue Across Multiple Cancer Types: a Feasibility Study (HoLST-F)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Royal Marsden NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ventana Medical Systems</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Royal Marsden NHS Foundation 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>
      Intratumour heterogeneity is well recognized in multiple cancer types and ultimately leads to&#xD;
      therapeutic resistance. It also limits the ability of small samples to represent the whole&#xD;
      tumour, having implications for diagnosis, molecular analysis and understanding of the tumour&#xD;
      immune microenvironment. By blending- 'homogenizing'- leftover tumour tissue in excess of&#xD;
      that required for diagnosistic purposes, one may create a more representative sample for&#xD;
      analysis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In order to establish the feasibility of homogenization as a potential companion diagnostic&#xD;
      tool, our study aims to 1) evaluate how many surgical cases have left over tissue amenable to&#xD;
      homogenization and 2) pilot homogenization across multiple tumour types. The molecular&#xD;
      profile of the homogenate will be compared to that obtained from the diagnostic specimen&#xD;
      using next generation sequencing techniques.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 10, 2018</start_date>
  <completion_date type="Anticipated">January 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2024</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The percentage of cases from surgical lists with tumour remains greater than 1g across 8 tumour groups</measure>
    <time_frame>24 Months</time_frame>
    <description>Surgical lists will be generated providing cases of all surgeries containing excess tumour tissue. The tissue will be dissected and weighed to determine if tumour tissue available is greater than 1g</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Median time (in minutes) required for dissection of the leftover surgical tissue into tumour, tumour-adjacent and normal tissue</measure>
    <time_frame>24 Months</time_frame>
    <description>The time taken to dissected will be documented by recording the start and stop times of the procedure and noting this on a source document</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median time (in minutes) required for the blending (actual homogenization) of each tissue type</measure>
    <time_frame>24 Months</time_frame>
    <description>The time taken to homogenize will be documented by recording the start and stop times of the procedure and noting this on a source document</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in molecular profile between the diagnostic block and the homogenized sample. This will be measured by next generation sequencing techniques across the 8 primary tumour types</measure>
    <time_frame>24 Months</time_frame>
    <description>The molecular profile of the diagnostic block will be determined by next generation sequencing and the same will be done with the homogenized sample. This will allow a comparison to be made between the two sample types and determine the difference in molecular profile between the two</description>
  </secondary_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Oncology</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Leftover surgical tissue homogenization</intervention_name>
    <description>Leftover surgical tissue homogenization</description>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      The investigators will be collecting leftover formalin-fixed surgical tissue homogenate and&#xD;
      FFPE tumour blocks&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Leftover formalin-fixed tissue from cancer surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Leftover formalin-fixed tissue (ie that would be otherwise discarded by&#xD;
             histopathology) from cancer surgery.&#xD;
&#xD;
          2. Tissues for Research consent has been provided.&#xD;
&#xD;
          3. Patient age &gt;18yo.&#xD;
&#xD;
          4. Minimum of 1 gram of residual tumour remaining in leftover surgical tissue&#xD;
&#xD;
          5. Minimum of 1 gram of normal tissue present.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Advanced Practitioner in histological dissection deems tumour sample to be inadequate.&#xD;
&#xD;
          2. Leftover surgical tumour tissue greater than 20kg.&#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>Samra Turajlic</last_name>
    <role>Principal Investigator</role>
    <affiliation>Royal Marsden NHS Foundation Trust</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Samra Turajlic</last_name>
    <phone>0207 811 8576</phone>
    <email>Samra.Turajlic@rmh.nhs.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Dilruba Kabir</last_name>
    <phone>0207 811 8153</phone>
    <email>Dilruba.Kabir@rmh.nhs.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Royal Marsden Hospital NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>SW3 6JJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ann Gandolfi</last_name>
      <phone>02086613903</phone>
      <email>ann.gandolfi@rmh.nhs.uk</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>April 8, 2022</last_update_submitted>
  <last_update_submitted_qc>April 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2022</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>Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03832062
org study id: CCR 4838
nct id: NCT03832062
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Intratumour heterogeneity is well recognized in multiple cancer types and ultimately leads to
      therapeutic resistance. It also limits the ability of small samples to represent the whole
      tumour, having implications for diagnosis, molecular analysis and understanding of the tumour
      immune microenvironment. By blending- 'homogenizing'- leftover tumour tissue in excess of
      that required for diagnosistic purposes, one may create a more representative sample for
      analysis.
In order to establish the feasibility of homogenization as a potential companion diagnostic
      tool, our study aims to 1) evaluate how many surgical cases have left over tissue amenable to
      homogenization and 2) pilot homogenization across multiple tumour types. The molecular
      profile of the homogenate will be compared to that obtained from the diagnostic specimen
      using next generation sequencing techniques.
observational model: Other
time perspective: Other
measure: The percentage of cases from surgical lists with tumour remains greater than 1g across 8 tumour groups
time frame: 24 Months
description: Surgical lists will be generated providing cases of all surgeries containing excess tumour tissue. The tissue will be dissected and weighed to determine if tumour tissue available is greater than 1g
measure: Median time (in minutes) required for dissection of the leftover surgical tissue into tumour, tumour-adjacent and normal tissue
time frame: 24 Months
description: The time taken to dissected will be documented by recording the start and stop times of the procedure and noting this on a source document
measure: Median time (in minutes) required for the blending (actual homogenization) of each tissue type
time frame: 24 Months
description: The time taken to homogenize will be documented by recording the start and stop times of the procedure and noting this on a source document
measure: Difference in molecular profile between the diagnostic block and the homogenized sample. This will be measured by next generation sequencing techniques across the 8 primary tumour types
time frame: 24 Months
description: The molecular profile of the diagnostic block will be determined by next generation sequencing and the same will be done with the homogenized sample. This will allow a comparison to be made between the two sample types and determine the difference in molecular profile between the two
intervention type: Other
intervention name: Leftover surgical tissue homogenization
description: Leftover surgical tissue homogenization
The investigators will be collecting leftover formalin-fixed surgical tissue homogenate and
      FFPE tumour blocks
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Samra Turajlic
role: Principal Investigator
affiliation: Royal Marsden NHS Foundation Trust
last name: Samra Turajlic
phone: 0207 811 8576
email: Samra.Turajlic@rmh.nhs.uk
last name: Dilruba Kabir
phone: 0207 811 8153
email: Dilruba.Kabir@rmh.nhs.uk
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Neoplasms
sharing ipd: Undecided