<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/NCT03840460</url>
  </required_header>
  <id_info>
    <org_study_id>CCR4753</org_study_id>
    <nct_id>NCT03840460</nct_id>
  </id_info>
  <brief_title>A Prospective Translational Tissue Collection Study in Early and Advanced Pancreatic Ductal Adenocarcinoma and Pancreatic Neuroendocrine Tumours to Enable Further Disease Characterisation and the Development of Potential Predictive and Prognostic Biomarkers</brief_title>
  <acronym>PaC-MAn</acronym>
  <official_title>A Prospective Translational Tissue Collection Study in Early and Advanced Pancreatic Ductal Adenocarcinoma (PDAC) and Pancreatic Neuroendocrine Tumours (PanNETs) to Enable Further Disease Characterisation and the Development of Potential Predictive and Prognostic Biomarkers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Royal Marsden NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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>
      There are several types of early pre-cancerous lesions found in the pancreas which have the&#xD;
      potential to develop into pancreatic cancer. Although different patients' pancreatic cancers&#xD;
      or pre-cancerous pancreatic lesions have many similarities we believe that subtle differences&#xD;
      can affect how they behave and therefore influence individual patient outcomes. Many factors&#xD;
      may account for the differences seen in pancreatic lesion behaviour, for example molecular&#xD;
      and genetic differences (the DNA and RNA present which control how a cell grows and divides),&#xD;
      differences in how the immune system responds to the lesion, differences in the environment&#xD;
      immediately around the lesion in the pancreas, known as the tumour microenvironment and&#xD;
      differences in the micro-organisms which colonize a particular patient, known as their&#xD;
      microbiota .&#xD;
&#xD;
      This project studies the molecular makeup of pancreatic lesions and their microenvironment at&#xD;
      various stages (from pre-cancerous lesions all the way through to more advanced disease) to&#xD;
      see if we can use this information to divide patients into different groups whose lesions may&#xD;
      behave in similar ways. We will be trying to find out if there are molecular reasons why some&#xD;
      patients respond to particular treatments when others do not, why some patients experience&#xD;
      more toxicity with particular treatments and why some patients' disease behaves particularly&#xD;
      aggressively when other patients' disease does not. We will also be investigating the&#xD;
      particular micro-organisms colonizing individual patients to see if these impact a patient's&#xD;
      outcome. Understanding what makes one person's pancreatic lesion behave differently to&#xD;
      another's could lead to better treatment, where a personalized therapeutic strategy could be&#xD;
      applied for every single patient.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main objective is to describe the incidence and distribution of tumour biomarkers, and to&#xD;
      identify molecular subgroups from a multicentre series of patients who are investigated for&#xD;
      and subsequently diagnosed with a pancreatic adenocarcinoma (PDAC) or a precursor lesion or a&#xD;
      pancreatic neuroendocrine tumour.&#xD;
&#xD;
      The secondary objective is to determine disease control rate (CR, PR and SD &gt;24 weeks),&#xD;
      duration of response, progression free survival (PFS) and overall survival (OS) in locally&#xD;
      advanced / metastatic patients or relapse free survival (RFS) and overall survival (OS) in&#xD;
      early stage curative / pre-cursor lesion patients, associated with the identified molecular&#xD;
      subtypes of PDAC pancreatic cancer and relevant anti-cancer therapies.&#xD;
&#xD;
      To identify molecular predictors of response or toxicity to standard of care anti-cancer&#xD;
      therapies in PDAC/PanNET. The study also has a number of exploratory objectives listed below:&#xD;
&#xD;
      Depending on the number of patients assessable for each biomarker of interest and the&#xD;
      prevalence of biomarker expression in the study population, exploratory endpoints of this&#xD;
      study include:&#xD;
&#xD;
        1. Evaluation of the predictive value of biomarker expression (i.e. the ability of a&#xD;
           biomarker to predict responsiveness or resistance to a specific anti-cancer treatment).&#xD;
&#xD;
        2. Evaluation of the prognostic value of biomarker expression (i.e. the ability of a&#xD;
           biomarker to predict outcome regardless of a specific anti-cancer treatment).&#xD;
&#xD;
        3. Comparison of biomarker expression among IPMN, MCN, and pancreatic adenocarcinoma and&#xD;
           evaluation of their prognostic value.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 10, 2019</start_date>
  <completion_date type="Anticipated">January 10, 2023</completion_date>
  <primary_completion_date type="Anticipated">January 10, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>to describe the incidence and distribution of biomarkers and identify molecular subtypes in a large, multi-centre, series of patients with pancreatic cancer and precursor lesions.</measure>
    <time_frame>4 years</time_frame>
    <description>Blood, urine, stool, saliva, bile and tissue samples from patients undergoing a tissue biopsy or surgery for suspected or known pancreatic cancer will be collected</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To describe the incidence and distribution of biomarkers and identify molecular subtypes in a large, multi-centre, population of patients with pancreatic cancer or precursor lesions.</measure>
    <time_frame>4 years</time_frame>
    <description>Molecular analyses including, but not limited to, miRNA analysis, DNA and RNA sequencing, nanostring, RT-PCR and immunohistochemistry will be carried out.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To identify molecular predictors of response or toxicity to standard of care anti-cancer therapies in PDAC/PanNET.</measure>
    <time_frame>4 years</time_frame>
    <description>Blood, urine, stool, saliva, bile and tissue samples from patients undergoing a tissue biopsy or surgery for suspected or known pancreatic cancer will be collected. Molecular analyses including, but not limited to, miRNA analysis, DNA and RNA sequencing, nanostring, RT-PCR and immunohistochemistry will be carried out.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Depending on the number of patients assessable for each biomarker of interest and the prevalence of biomarker expression in the study population, exploratory endpoints of this study include</measure>
    <time_frame>4 years</time_frame>
    <description>evaluation of the predictive value of biomarker expression (i.e. the ability of a biomarker to predict responsiveness or resistance to a specific anti-cancer treatment).</description>
  </other_outcome>
  <other_outcome>
    <measure>Depending on the number of patients assessable for each biomarker of interest and the prevalence of biomarker expression in the study population, exploratory endpoints of this study include</measure>
    <time_frame>4 years</time_frame>
    <description>evaluation of the prognostic value of biomarker expression (i.e. the ability of a biomarker to predict outcome regardless of a specific anti-cancer treatment).</description>
  </other_outcome>
  <other_outcome>
    <measure>Depending on the number of patients assessable for each biomarker of interest and the prevalence of biomarker expression in the study population, exploratory endpoints of this study include</measure>
    <time_frame>4 years</time_frame>
    <description>comparison of biomarker expression among IPMN, MCN, and pancreatic adenocarcinoma and evaluation of their prognostic value.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Pancreatic Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>Pancreatic Cancer</arm_group_label>
    <description>Patients who are investigated for and subsequently diagnosed with early/advanced pancreatic adenocarcinoma or a precursor lesion or a pancreatic neuroendocrine tumour.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      The collected blood and tissue will undergo molecular analyses, including but not limited to,&#xD;
      miRNA analysis, DNA and RNA sequencing, nanostring, real-time PCR and immunohistochemistry.&#xD;
      Molecular analysis data will be correlated with clinical outcome data and allow&#xD;
      characterization of subtypes in pancreatic cancer, considering both pancreatic ductal&#xD;
      adenocarcinoma and pancreatic neuroendocrine tumours.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        early/advanced pancreatic adenocarcinoma or a precursor lesion or a pancreatic&#xD;
        neuroendocrine tumour.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient is being investigated or treated for pancreatic cancer or precursor lesions at&#xD;
             The Royal Marsden Hospital and referring centres during the study period.&#xD;
&#xD;
          2. Patient has a histologically/cytologically confirmed diagnosis of pancreatic ductal&#xD;
             adenocarcinoma, or pancreatic neuroendocrine tumour OR Patient has a tissue lesion&#xD;
             suspicious for pancreatic cancer amenable to core needle biopsy or surgery and is&#xD;
             clinically fit enough to undergo a tumour biopsy or surgery according to investigator&#xD;
             assessment and local guidelines.&#xD;
&#xD;
          3. Patient is ≥ 18 years of age.&#xD;
&#xD;
          4. Patient can understand the patient information sheet and is able to provide written&#xD;
             informed consent.&#xD;
&#xD;
          5. Patient has sufficient tissue and/or blood and/or urine and/or stool and/or saliva&#xD;
             sampling for analysis as per the protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Patients who are not treated at all at The Royal Marsden Hospital or referring centre.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Patient is ≥ 18 years of age.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>David Cunningham</last_name>
    <role>Study Chair</role>
    <affiliation>The Royal Marsden Hospital NHS Foundation Trust</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bijal Patel</last_name>
    <phone>02086426011</phone>
    <phone_ext>4450</phone_ext>
    <email>bijal.patel@rmh.nhs.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>David Lau</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The Royal Marsden NHS Foundation Trust</name>
      <address>
        <city>Sutton</city>
        <state>Surrey</state>
        <zip>SM2 5PT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bijal Patel</last_name>
      <phone>02086426011</phone>
      <phone_ext>4450</phone_ext>
      <email>bijal.patel@rmh.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>David Lau</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>February 7, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>February 19, 2020</last_update_submitted>
  <last_update_submitted_qc>February 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2020</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>Adenocarcinoma</mesh_term>
    <mesh_term>Neuroendocrine Tumors</mesh_term>
  </condition_browse>
  <!-- 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/NCT03840460
org study id: CCR4753
nct id: NCT03840460
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
There are several types of early pre-cancerous lesions found in the pancreas which have the
      potential to develop into pancreatic cancer. Although different patients' pancreatic cancers
      or pre-cancerous pancreatic lesions have many similarities we believe that subtle differences
      can affect how they behave and therefore influence individual patient outcomes. Many factors
      may account for the differences seen in pancreatic lesion behaviour, for example molecular
      and genetic differences (the DNA and RNA present which control how a cell grows and divides),
      differences in how the immune system responds to the lesion, differences in the environment
      immediately around the lesion in the pancreas, known as the tumour microenvironment and
      differences in the micro-organisms which colonize a particular patient, known as their
      microbiota .

      This project studies the molecular makeup of pancreatic lesions and their microenvironment at
      various stages (from pre-cancerous lesions all the way through to more advanced disease) to
      see if we can use this information to divide patients into different groups whose lesions may
      behave in similar ways. We will be trying to find out if there are molecular reasons why some
      patients respond to particular treatments when others do not, why some patients experience
      more toxicity with particular treatments and why some patients' disease behaves particularly
      aggressively when other patients' disease does not. We will also be investigating the
      particular micro-organisms colonizing individual patients to see if these impact a patient's
      outcome. Understanding what makes one person's pancreatic lesion behave differently to
      another's could lead to better treatment, where a personalized therapeutic strategy could be
      applied for every single patient.
The main objective is to describe the incidence and distribution of tumour biomarkers, and to
      identify molecular subgroups from a multicentre series of patients who are investigated for
      and subsequently diagnosed with a pancreatic adenocarcinoma (PDAC) or a precursor lesion or a
      pancreatic neuroendocrine tumour.

      The secondary objective is to determine disease control rate (CR, PR and SD >24 weeks),
      duration of response, progression free survival (PFS) and overall survival (OS) in locally
      advanced / metastatic patients or relapse free survival (RFS) and overall survival (OS) in
      early stage curative / pre-cursor lesion patients, associated with the identified molecular
      subtypes of PDAC pancreatic cancer and relevant anti-cancer therapies.

      To identify molecular predictors of response or toxicity to standard of care anti-cancer
      therapies in PDAC/PanNET. The study also has a number of exploratory objectives listed below:

      Depending on the number of patients assessable for each biomarker of interest and the
      prevalence of biomarker expression in the study population, exploratory endpoints of this
      study include:

        1. Evaluation of the predictive value of biomarker expression (i.e. the ability of a
           biomarker to predict responsiveness or resistance to a specific anti-cancer treatment).

        2. Evaluation of the prognostic value of biomarker expression (i.e. the ability of a
           biomarker to predict outcome regardless of a specific anti-cancer treatment).

        3. Comparison of biomarker expression among IPMN, MCN, and pancreatic adenocarcinoma and
           evaluation of their prognostic value.
observational model: Cohort
time perspective: Prospective
measure: to describe the incidence and distribution of biomarkers and identify molecular subtypes in a large, multi-centre, series of patients with pancreatic cancer and precursor lesions.
time frame: 4 years
description: Blood, urine, stool, saliva, bile and tissue samples from patients undergoing a tissue biopsy or surgery for suspected or known pancreatic cancer will be collected
measure: To describe the incidence and distribution of biomarkers and identify molecular subtypes in a large, multi-centre, population of patients with pancreatic cancer or precursor lesions.
time frame: 4 years
description: Molecular analyses including, but not limited to, miRNA analysis, DNA and RNA sequencing, nanostring, RT-PCR and immunohistochemistry will be carried out.
measure: To identify molecular predictors of response or toxicity to standard of care anti-cancer therapies in PDAC/PanNET.
time frame: 4 years
description: Blood, urine, stool, saliva, bile and tissue samples from patients undergoing a tissue biopsy or surgery for suspected or known pancreatic cancer will be collected. Molecular analyses including, but not limited to, miRNA analysis, DNA and RNA sequencing, nanostring, RT-PCR and immunohistochemistry will be carried out.
measure: Depending on the number of patients assessable for each biomarker of interest and the prevalence of biomarker expression in the study population, exploratory endpoints of this study include
time frame: 4 years
description: evaluation of the predictive value of biomarker expression (i.e. the ability of a biomarker to predict responsiveness or resistance to a specific anti-cancer treatment).
measure: Depending on the number of patients assessable for each biomarker of interest and the prevalence of biomarker expression in the study population, exploratory endpoints of this study include
time frame: 4 years
description: evaluation of the prognostic value of biomarker expression (i.e. the ability of a biomarker to predict outcome regardless of a specific anti-cancer treatment).
measure: Depending on the number of patients assessable for each biomarker of interest and the prevalence of biomarker expression in the study population, exploratory endpoints of this study include
time frame: 4 years
description: comparison of biomarker expression among IPMN, MCN, and pancreatic adenocarcinoma and evaluation of their prognostic value.
arm group label: Pancreatic Cancer
description: Patients who are investigated for and subsequently diagnosed with early/advanced pancreatic adenocarcinoma or a precursor lesion or a pancreatic neuroendocrine tumour.
The collected blood and tissue will undergo molecular analyses, including but not limited to,
      miRNA analysis, DNA and RNA sequencing, nanostring, real-time PCR and immunohistochemistry.
      Molecular analysis data will be correlated with clinical outcome data and allow
      characterization of subtypes in pancreatic cancer, considering both pancreatic ductal
      adenocarcinoma and pancreatic neuroendocrine tumours.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
gender based: Yes
gender description: Patient is ≥ 18 years of age.
minimum age: 18 Years
maximum age: N/A
last name: David Cunningham
role: Study Chair
affiliation: The Royal Marsden Hospital NHS Foundation Trust
last name: Bijal Patel
phone: 02086426011
phone ext: 4450
email: bijal.patel@rmh.nhs.uk
last name: David Lau
facility: 
status: Recruiting
contact: 
investigator: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Adenocarcinoma
mesh term: Neuroendocrine Tumors