<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/NCT03300102</url>
  </required_header>
  <id_info>
    <org_study_id>17/0351</org_study_id>
    <nct_id>NCT03300102</nct_id>
  </id_info>
  <brief_title>Acceptability and Feasibility Study of Patient-specific 'Tumouroids' as Personalised Treatment Screening Tools</brief_title>
  <acronym>Tumouroids</acronym>
  <official_title>A Single Site Study Accessing the Acceptability and Feasibility of Patient-specific 'Tumouroids' as Personalised Treatment Screening Tools</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University College, London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University College, London</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>
      In England, more than three hundred thousand people are diagnosed with cancer each year. The&#xD;
      diagnostic and treatment pathways for multiple cancers have greatly developed over the past&#xD;
      decade. However, novel treatments are expensive and currently discrimination between&#xD;
      responders and non-responders is still suboptimal. There is a pressing need to develop tools&#xD;
      that allow for better disease characterisation and stratification. Personalised medicine,&#xD;
      whereby prevention, diagnosis, and treatment of diseases is aimed at the individual level, is&#xD;
      a growing field. Predicting patient-specific treatment response is challenging as response&#xD;
      depends not only on the characteristics of cancer cells but also on how these cells interact&#xD;
      with their immediate surrounding environment and on how the tumour interacts with the host. A&#xD;
      simplistic model is therefore insufficient to predict treatment response. Complex,&#xD;
      patient-derived animal models have been used to this effect but are expensive, may take up to&#xD;
      6 months to provide clinically relevant answers, and pose ethical issues. In the past in&#xD;
      vitro models lacked complexity as they were based solely on the two-dimensional (2D) growth&#xD;
      of cancer cells. Nowadays the use of 3D tumour models has provided an extra level of&#xD;
      complexity to in vitro studies. With these models it is possible to recreate tumour&#xD;
      characteristics that were lost in 2D, such as cell-cell interaction between cancer cells and&#xD;
      between cancer and stromal cells, cell-matrix interaction, or hypoxia.&#xD;
&#xD;
      The investigators have developed a 3D complex tumour model - named tumouroid. Using this&#xD;
      model, preliminary work has been undertaken which allows the growth of patient-derived&#xD;
      tumouroids using primary cancer cells from patients.&#xD;
&#xD;
      This personalised platform can be challenged by therapeutics used in clinical practice and&#xD;
      response to treatment can be assessed via appropriate assays.&#xD;
&#xD;
      The study goals are twofold:&#xD;
&#xD;
      To assess patient acceptability to the use of patient derived tumour models for future&#xD;
      decision-making, and To assess the feasibility of generating patient derived renal cancer&#xD;
      tumouroids and using them as platforms to test drug response.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This trial is a prospective tissue collection of renal cell carcinoma samples, including&#xD;
      collection of data using both structured Likert 12 item questionnaires and semi structured&#xD;
      interviews to assess acceptability. With the development of patient-derived tumouroids the&#xD;
      investigators would like to overcome the current over-simplified strategies that focus on&#xD;
      genetic markers as predictors of response. In the future, the investigators hope to establish&#xD;
      tumouroids as a personalised platform to predict patient response to treatment that is more&#xD;
      cost-efficient and poses less ethical issues than animal platforms.&#xD;
&#xD;
      This project will assess if patient-derived tumouroids can be therapeutically challenged and&#xD;
      if patients would be willing to accept that such platform to guide clinical treatment&#xD;
      decision making.&#xD;
&#xD;
      This study is designed to assess primarily patient acceptability. Acceptability will be&#xD;
      elicited using Likert scale non-validated questionnaires and in a semi-structured interview&#xD;
      in which the views and preferences relating the acceptability or otherwise of the patient&#xD;
      derived tumour models and their impact on future decision making will be explored.&#xD;
&#xD;
      The study will also assess feasibility of building tumouroids and challenging them.&#xD;
      Feasibility will address the successful transition between the critical phases of generating&#xD;
      a viable and responsive tumour model. This begins with the extraction of cancer cells from&#xD;
      the explanted tumour and ends with the determination of a response or otherwise to a&#xD;
      therapeutic challenge of the viable tumour model at a range of in vitro concentrations.&#xD;
&#xD;
      The findings of this study will be presented at conference(s) and manuscripts will be&#xD;
      submitted to appropriate journals for publication.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2018</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">August 1, 2018</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>Acceptability</measure>
    <time_frame>Up to 10 weeks after consent</time_frame>
    <description>Measured using a Likert scale non-validated structured questionnaire and/or complete a semi structured interview.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Feasibility : Number of tumour tissue samples collected</measure>
    <time_frame>Up to 10 weeks after consent</time_frame>
    <description>Number of tumour tissue samples that can be collected within the time frame from consented patients this will be counted.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility : Gross morphology, weight and size of each sample</measure>
    <time_frame>Up to 10 weeks after consent</time_frame>
    <description>Each sample obtained will be weighed and measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility : Cell count after isolation</measure>
    <time_frame>Up to 10 weeks after consent</time_frame>
    <description>A physical count of the number of cells isolated from each sample will be collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility: Cell growth method and time</measure>
    <time_frame>10 days after tumouroid establishment</time_frame>
    <description>Measurements will be taken of each tumouroid as it grows, each tumouroid will be given ten days to grow at day ten drug challenge will begin..</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility: Drug concentrations tested</measure>
    <time_frame>On day 10 after tumouroid establishment</time_frame>
    <description>A log will be kept of the drug concentrations used on all tumouroids.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility: Duration of drug exposure</measure>
    <time_frame>5 days of drug exposure</time_frame>
    <description>Number of days tumouroid was exposed to drug</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility: Drug challenge response</measure>
    <time_frame>within 6 days of the end of drug exposure.</time_frame>
    <description>At the end of 5 days of drug exposure tumouroids will be assessed for response to the drug using a commercially available kit that assesses cell metabolism and viability. In addition, tumouroids will be fixed so that cell morphology will be assessed within 6 days of the end of drug exposure.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">19</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Patients with suspected or confirmed renal cell carcinoma</arm_group_label>
    <description>Patients with suspected or confirmed renal cell carcinoma who have consented will either donate tissue, or complete a structured questionnaire or a semi-structured interview. Not all patients will have all three interventions, each patient must have at least one.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaires, interviews and or tissue donation</intervention_name>
    <description>Subjects will be asked to complete either structured questionnaires, semi-structured interviews or donate tissue. There will be some overlap, but each subject does not have to do all three interventions.</description>
    <arm_group_label>Patients with suspected or confirmed renal cell carcinoma</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Male or female patients aged 18 or over, sufficient command of English language to complete&#xD;
        consent forms and questionnaires, suspected or confirmed renal cell carcinoma.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (≥18 years old), of either gender, able to provide consent;&#xD;
&#xD;
          -  Suspected or confirmed renal cell carcinoma;&#xD;
&#xD;
          -  Signed informed consent by patient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-English speaker;&#xD;
&#xD;
          -  Inability to provide informed consent&#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>Mark Emberton</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor of Interventional Oncology, UCL</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Surgical &amp; Interventional Trials Unit</name>
      <address>
        <city>London</city>
        <zip>NW12BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Free Hospital</name>
      <address>
        <city>London</city>
        <zip>NW3 2QG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>July 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>January 22, 2019</last_update_submitted>
  <last_update_submitted_qc>January 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>personalised medicine</keyword>
  <!-- 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/NCT03300102
org study id: 17/0351
nct id: NCT03300102
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In England, more than three hundred thousand people are diagnosed with cancer each year. The
      diagnostic and treatment pathways for multiple cancers have greatly developed over the past
      decade. However, novel treatments are expensive and currently discrimination between
      responders and non-responders is still suboptimal. There is a pressing need to develop tools
      that allow for better disease characterisation and stratification. Personalised medicine,
      whereby prevention, diagnosis, and treatment of diseases is aimed at the individual level, is
      a growing field. Predicting patient-specific treatment response is challenging as response
      depends not only on the characteristics of cancer cells but also on how these cells interact
      with their immediate surrounding environment and on how the tumour interacts with the host. A
      simplistic model is therefore insufficient to predict treatment response. Complex,
      patient-derived animal models have been used to this effect but are expensive, may take up to
      6 months to provide clinically relevant answers, and pose ethical issues. In the past in
      vitro models lacked complexity as they were based solely on the two-dimensional (2D) growth
      of cancer cells. Nowadays the use of 3D tumour models has provided an extra level of
      complexity to in vitro studies. With these models it is possible to recreate tumour
      characteristics that were lost in 2D, such as cell-cell interaction between cancer cells and
      between cancer and stromal cells, cell-matrix interaction, or hypoxia.

      The investigators have developed a 3D complex tumour model - named tumouroid. Using this
      model, preliminary work has been undertaken which allows the growth of patient-derived
      tumouroids using primary cancer cells from patients.

      This personalised platform can be challenged by therapeutics used in clinical practice and
      response to treatment can be assessed via appropriate assays.

      The study goals are twofold:

      To assess patient acceptability to the use of patient derived tumour models for future
      decision-making, and To assess the feasibility of generating patient derived renal cancer
      tumouroids and using them as platforms to test drug response.
This trial is a prospective tissue collection of renal cell carcinoma samples, including
      collection of data using both structured Likert 12 item questionnaires and semi structured
      interviews to assess acceptability. With the development of patient-derived tumouroids the
      investigators would like to overcome the current over-simplified strategies that focus on
      genetic markers as predictors of response. In the future, the investigators hope to establish
      tumouroids as a personalised platform to predict patient response to treatment that is more
      cost-efficient and poses less ethical issues than animal platforms.

      This project will assess if patient-derived tumouroids can be therapeutically challenged and
      if patients would be willing to accept that such platform to guide clinical treatment
      decision making.

      This study is designed to assess primarily patient acceptability. Acceptability will be
      elicited using Likert scale non-validated questionnaires and in a semi-structured interview
      in which the views and preferences relating the acceptability or otherwise of the patient
      derived tumour models and their impact on future decision making will be explored.

      The study will also assess feasibility of building tumouroids and challenging them.
      Feasibility will address the successful transition between the critical phases of generating
      a viable and responsive tumour model. This begins with the extraction of cancer cells from
      the explanted tumour and ends with the determination of a response or otherwise to a
      therapeutic challenge of the viable tumour model at a range of in vitro concentrations.

      The findings of this study will be presented at conference(s) and manuscripts will be
      submitted to appropriate journals for publication.
observational model: Cohort
time perspective: Prospective
measure: Acceptability
time frame: Up to 10 weeks after consent
description: Measured using a Likert scale non-validated structured questionnaire and/or complete a semi structured interview.
measure: Feasibility : Number of tumour tissue samples collected
time frame: Up to 10 weeks after consent
description: Number of tumour tissue samples that can be collected within the time frame from consented patients this will be counted.
measure: Feasibility : Gross morphology, weight and size of each sample
time frame: Up to 10 weeks after consent
description: Each sample obtained will be weighed and measured.
measure: Feasibility : Cell count after isolation
time frame: Up to 10 weeks after consent
description: A physical count of the number of cells isolated from each sample will be collected.
measure: Feasibility: Cell growth method and time
time frame: 10 days after tumouroid establishment
description: Measurements will be taken of each tumouroid as it grows, each tumouroid will be given ten days to grow at day ten drug challenge will begin..
measure: Feasibility: Drug concentrations tested
time frame: On day 10 after tumouroid establishment
description: A log will be kept of the drug concentrations used on all tumouroids.
measure: Feasibility: Duration of drug exposure
time frame: 5 days of drug exposure
description: Number of days tumouroid was exposed to drug
measure: Feasibility: Drug challenge response
time frame: within 6 days of the end of drug exposure.
description: At the end of 5 days of drug exposure tumouroids will be assessed for response to the drug using a commercially available kit that assesses cell metabolism and viability. In addition, tumouroids will be fixed so that cell morphology will be assessed within 6 days of the end of drug exposure.
arm group label: Patients with suspected or confirmed renal cell carcinoma
description: Patients with suspected or confirmed renal cell carcinoma who have consented will either donate tissue, or complete a structured questionnaire or a semi-structured interview. Not all patients will have all three interventions, each patient must have at least one.
intervention type: Other
intervention name: Questionnaires, interviews and or tissue donation
description: Subjects will be asked to complete either structured questionnaires, semi-structured interviews or donate tissue. There will be some overlap, but each subject does not have to do all three interventions.
arm group label: Patients with suspected or confirmed renal cell carcinoma
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mark Emberton
role: Principal Investigator
affiliation: Professor of Interventional Oncology, UCL
facility: 
facility: 
country: United Kingdom
responsible party type: Sponsor