<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/NCT03303547</url>
  </required_header>
  <id_info>
    <org_study_id>DOCUMAS: 23HH8158</org_study_id>
    <nct_id>NCT03303547</nct_id>
  </id_info>
  <brief_title>Concordance of Imaging and Pathology Diagnosis of Extranodal Tumour Deposits</brief_title>
  <acronym>COMET</acronym>
  <official_title>Concordance of Imaging and Pathology Diagnosis of Extranodal Tumour Deposits</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Imperial College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pelican Cancer Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Imperial College London</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>
      Any patient with a suspected primary adenocarcinoma of the colon, sigmoid or rectum&#xD;
      undergoing surgery are eligible. The date of surgery must be known prior to registration.&#xD;
      This trial aims to determine if image mapping techniques can improve the concordance between&#xD;
      imaging and pathology detection of tumour deposits. Lymph nodes and tumour deposits will be&#xD;
      identified on pre-operative scans and mapped by radiologists then shared with pathologists&#xD;
      prior to processing the resected specimen. Patients will be managed at their local hospital&#xD;
      with standard follow-up. Patients will be followed up for 5 years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective interventional multi-centre study, COMET aims to prove the accuracy of imaging&#xD;
      diagnosis of extranodal tumour deposits (TD) and their adverse effect on prognosis of&#xD;
      colorectal cancers. The proposed intervention will be additional radiological and&#xD;
      pathological assessment and the reporting of supplementary diagnostic information which would&#xD;
      not otherwise have been available. This may affect treatment according to local MDT protocols&#xD;
      and also affect the provision of prognostic information to patients in subsequent&#xD;
      discussions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 16, 2017</start_date>
  <completion_date type="Anticipated">December 2029</completion_date>
  <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To determine whether the prevalence of TD on pathology is found to be higher if imaging mapping is used.</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Comparison of the proportion of patients with TD on imaging with proportion of patients with TD on histopathology defined as 'nodules without definite features of lymph node architecture'</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To determine whether lesions classified as TD on Imaging correspond to the pathological diagnosis of TD.</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Correspondence of nodules identified as tumour deposits on imaging and nodules identified as tumour deposits on the corresponding pathology slice</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine the effect of Imaging and pathological diagnosis of TD on disease free survival (at one, three and five years), overall survival (at one, three and five years) and time to local recurrence.</measure>
    <time_frame>1, 3 and 5 years</time_frame>
    <description>Survival and recurrence outcomes according to Imaging and histopathology TD status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To investigate features of the primary tumour compared with tumour deposits</measure>
    <time_frame>Up to 2 years and up to 5 years follow up</time_frame>
    <description>Comparison of immunohistochemical and morphological features of tumour</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To investigate features of the primary tumour compared with lymph nodes</measure>
    <time_frame>Up to 2 years and up to 5 years follow up</time_frame>
    <description>Comparison of immunohistochemical and morphological features of tumour</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To objectively record the features seen which help distinguish a LN from an TD and attempt to refine and clarify the definitions used in pathology.</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Comparison of histopathological known features in patients with MR defined TD vs lymph nodes e.g. capsule, peripheral lymphocyte ring, vessel wall, &quot;lone arteriole sign&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To objectively record the features seen which help distinguish a LN from an TD</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Comparison of histopathological known features in patients with MR defined TD vs lymph nodes e.g. capsule, peripheral lymphocyte ring, vessel wall, &quot;lone arteriole sign&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess inter-observer agreement between the local pathologist and the central reviewing pathologist.</measure>
    <time_frame>Up to 2 years0</time_frame>
    <description>Overall comparison of professional agreement between specialists on TD status at recruiting site vs central review - description of location and number of tumour deposits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess inter-observer agreement between the local radiologist and central reviewing radiologist.</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Overall comparison of professional agreement between specialists on TD status at recruiting site vs central review - description of location and number of tumour deposits</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Adenocarcinoma of the Rectum</condition>
  <arm_group>
    <arm_group_label>MRI-Pathology N1c matching group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MRI mapping will be used to guide pathologists to sample areas of the mesorectum where tumour deposits are likely to be present.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>MRI mapping to guide pathological sampling of extranodal tumour deposits</intervention_name>
    <description>Radiologist to mark areas where extranodal disease is identified on MRI. The pathologist will use this to take additional samples for analysis. This will allow better pathological staging and will affect treatment decisions for patients.</description>
    <arm_group_label>MRI-Pathology N1c matching group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Suspected primary adenocarcinoma of the colon, sigmoid or rectum (proven by biopsy&#xD;
             taken as part of routine clinical practice, patients to be withdrawn if not&#xD;
             subsequently adenocarcinoma on pathology).&#xD;
&#xD;
          2. Amenable to surgical resection.&#xD;
&#xD;
          3. Disease spread assessed on imaging&#xD;
&#xD;
          4. Patients having primary surgery and those undergoing neoadjuvant treatment will be&#xD;
             included.&#xD;
&#xD;
          5. All must have had baseline staging scans and those undergoing neoadjuvant therapy must&#xD;
             also have had a post-treatment scan.&#xD;
&#xD;
          6. Patients aged 16 years and over&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with recurrent tumours&#xD;
&#xD;
          2. Synchronous tumours&#xD;
&#xD;
          3. Under the age of 16 years&#xD;
&#xD;
          4. Unable to give informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gina Brown, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Imperial College London</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Caroline Martin</last_name>
    <phone>+44 (0) 7749 655 817</phone>
    <email>c.martin1@imperial.ac.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Syvella Ellis</last_name>
    <phone>+44 (0) 7732 315 234</phone>
    <email>giclinicaltrials@imperial.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Royal Marsden Hospital NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <state>Surrey</state>
        <zip>SM2 5PT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cordelia Grant</last_name>
      <email>cordelia.grant@rmh.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>Monica Terlizzo, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <last_update_submitted>September 1, 2023</last_update_submitted>
  <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>MRI</keyword>
  <keyword>Tissue</keyword>
  <keyword>Imaging</keyword>
  <keyword>Pathology</keyword>
  <keyword>Rectal</keyword>
  <keyword>Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Extranodal Extension</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/NCT03303547
org study id: DOCUMAS: 23HH8158
nct id: NCT03303547
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Any patient with a suspected primary adenocarcinoma of the colon, sigmoid or rectum
      undergoing surgery are eligible. The date of surgery must be known prior to registration.
      This trial aims to determine if image mapping techniques can improve the concordance between
      imaging and pathology detection of tumour deposits. Lymph nodes and tumour deposits will be
      identified on pre-operative scans and mapped by radiologists then shared with pathologists
      prior to processing the resected specimen. Patients will be managed at their local hospital
      with standard follow-up. Patients will be followed up for 5 years.
A prospective interventional multi-centre study, COMET aims to prove the accuracy of imaging
      diagnosis of extranodal tumour deposits (TD) and their adverse effect on prognosis of
      colorectal cancers. The proposed intervention will be additional radiological and
      pathological assessment and the reporting of supplementary diagnostic information which would
      not otherwise have been available. This may affect treatment according to local MDT protocols
      and also affect the provision of prognostic information to patients in subsequent
      discussions.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: To determine whether the prevalence of TD on pathology is found to be higher if imaging mapping is used.
time frame: Up to 2 years
description: Comparison of the proportion of patients with TD on imaging with proportion of patients with TD on histopathology defined as 'nodules without definite features of lymph node architecture'
measure: To determine whether lesions classified as TD on Imaging correspond to the pathological diagnosis of TD.
time frame: Up to 2 years
description: Correspondence of nodules identified as tumour deposits on imaging and nodules identified as tumour deposits on the corresponding pathology slice
measure: To determine the effect of Imaging and pathological diagnosis of TD on disease free survival (at one, three and five years), overall survival (at one, three and five years) and time to local recurrence.
time frame: 1, 3 and 5 years
description: Survival and recurrence outcomes according to Imaging and histopathology TD status
measure: To investigate features of the primary tumour compared with tumour deposits
time frame: Up to 2 years and up to 5 years follow up
description: Comparison of immunohistochemical and morphological features of tumour
measure: To investigate features of the primary tumour compared with lymph nodes
time frame: Up to 2 years and up to 5 years follow up
description: Comparison of immunohistochemical and morphological features of tumour
measure: To objectively record the features seen which help distinguish a LN from an TD and attempt to refine and clarify the definitions used in pathology.
time frame: Up to 2 years
description: Comparison of histopathological known features in patients with MR defined TD vs lymph nodes e.g. capsule, peripheral lymphocyte ring, vessel wall, "lone arteriole sign"
measure: To objectively record the features seen which help distinguish a LN from an TD
time frame: Up to 2 years
description: Comparison of histopathological known features in patients with MR defined TD vs lymph nodes e.g. capsule, peripheral lymphocyte ring, vessel wall, "lone arteriole sign"
measure: To assess inter-observer agreement between the local pathologist and the central reviewing pathologist.
time frame: Up to 2 years0
description: Overall comparison of professional agreement between specialists on TD status at recruiting site vs central review - description of location and number of tumour deposits
measure: To assess inter-observer agreement between the local radiologist and central reviewing radiologist.
time frame: Up to 2 years
description: Overall comparison of professional agreement between specialists on TD status at recruiting site vs central review - description of location and number of tumour deposits
arm group label: MRI-Pathology N1c matching group
arm group type: Experimental
description: MRI mapping will be used to guide pathologists to sample areas of the mesorectum where tumour deposits are likely to be present.
intervention type: Diagnostic Test
intervention name: MRI mapping to guide pathological sampling of extranodal tumour deposits
description: Radiologist to mark areas where extranodal disease is identified on MRI. The pathologist will use this to take additional samples for analysis. This will allow better pathological staging and will affect treatment decisions for patients.
arm group label: MRI-Pathology N1c matching group
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Gina Brown, MD
role: Principal Investigator
affiliation: Imperial College London
last name: Caroline Martin
phone: +44 (0) 7749 655 817
email: c.martin1@imperial.ac.uk
last name: Syvella Ellis
phone: +44 (0) 7732 315 234
email: giclinicaltrials@imperial.ac.uk
facility: 
status: Recruiting
contact: 
investigator: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Extranodal Extension
sharing ipd: No