<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/NCT03835520</url>
  </required_header>
  <id_info>
    <org_study_id>UCL-ONCO 2018-02</org_study_id>
    <secondary_id>2018/11JUI/248</secondary_id>
    <secondary_id>B403201836842</secondary_id>
    <nct_id>NCT03835520</nct_id>
  </id_info>
  <brief_title>Prospective Collection of Tumor Biopsy and Plasma Samples From Cancer Patients Treated With Molecular Targeted Therapies or Immunotherapy</brief_title>
  <acronym>Plasma-Target</acronym>
  <official_title>Prospective Collection of Tumor Biopsy and Plasma Samples From Cancer Patients Treated With Molecular Targeted Therapies or Immunotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cliniques universitaires Saint-Luc- Université Catholique de Louvain</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cliniques universitaires Saint-Luc- Université Catholique de Louvain</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>
      The purpose of this study is to collect blood samples, as well as tumor tissue for genetic&#xD;
      analysis. The collection of samples will allow the creation of a plasma bank. Targeted&#xD;
      individuals are cancer patients of all types, treated with immunotherapy or targeted therapy.&#xD;
&#xD;
      Immunotherapy or targeted agents will be administered according to standard of care and&#xD;
      reimbursement modalities in Belgium. Targeted agents will be administered according to&#xD;
      manufacturer's instructions.&#xD;
&#xD;
      With the aim to identify predictive markers of response to treatment or possible resistance&#xD;
      mechanism, the plasma samples and the tumor samples will be used for genetic analysis, for&#xD;
      example but not limited to, whole exome sequencing. This may lead to the discovery of some&#xD;
      germinal mutations implicated in other diseases than cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 11, 2018</start_date>
  <completion_date type="Anticipated">May 1, 2028</completion_date>
  <primary_completion_date type="Anticipated">May 2028</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The trial will include patients with any type of cancer treated with one of the following regimens after signing of the patient's informed consent:&#xD;
I: Molecular targeted agent&#xD;
II: Immunotherapy</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Masking and allocation tbc</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>efficacy of treatment against Cancer</measure>
    <time_frame>From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months</time_frame>
    <description>Efficacy will be determined in terms of overall responses according to standard practice by the local investigator. Disease and response assessments are defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>From date of randomization until the date of first documented progression assessed up to 120 months</time_frame>
    <description>Overall survival is defined as the time from the date of inclusion to the date of death from any cause or to the date of last follow-up (in exceptional cases where it is impossible to document the date of death). Every effort should be made to document the cause of death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival</measure>
    <time_frame>From date of randomization until the date of first documented progression , assessed up to 120 months</time_frame>
    <description>Progression free survival (PFS) will be measured from the date of inclusion to the date of progression or death, whatever the cause.&#xD;
Progression will be defined according to the RECIST criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective tumor response</measure>
    <time_frame>From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months</time_frame>
    <description>Objective tumor response will be measured according to the RECIST 1.1 criteria.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>MOLECULAR TARGETED THERAPIES</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Immunotherapy will be administered according to standard of care and reimbursement modalities in Belgium. Targeted agents will be administered according to manufacturer's instructions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IMMUNOTHERAPY</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Immunotherapy will be administered according to standard of care and reimbursement modalities in Belgium.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Immunotherapeutic Agent</intervention_name>
    <description>Immunotherapy will be administered according to standard of care and reimbursement modalities in Belgium.</description>
    <arm_group_label>IMMUNOTHERAPY</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Molecular Target</intervention_name>
    <description>Targeted agents will be administered according to standard of care and reimbursement modalities in Belgium. Targeted agents will be administered according to manufacturer's instructions.</description>
    <arm_group_label>MOLECULAR TARGETED THERAPIES</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with cancer treated with one of the following regimens: Molecular targeted&#xD;
             agents or Immunotherapy&#xD;
&#xD;
          -  Paraffin-embedded tumor tissue available for immunohistochemistry and/or DNA&#xD;
             extraction.&#xD;
&#xD;
          -  Patient able to give written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with cancer treated with other regimen&#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_contact>
    <last_name>Matthias Papier</last_name>
    <phone>+32 2 764 78 49</phone>
    <email>matthias.papier@uclouvain.be</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cliniques Universitaires Saint-Luc</name>
      <address>
        <city>Brussels</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Matthias Papier</last_name>
      <phone>+32 2 764 78 49</phone>
      <email>matthias.papier@uclouvain.be</email>
    </contact>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>October 8, 2018</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>March 18, 2021</last_update_submitted>
  <last_update_submitted_qc>March 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Immunotherapy</keyword>
  <keyword>Molecular Targeted Therapies</keyword>
  <keyword>Tumor Biopsy</keyword>
  <keyword>Plasma Samples</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Immunomodulating Agents</mesh_term>
  </intervention_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/NCT03835520
org study id: UCL-ONCO 2018-02
secondary id: 2018/11JUI/248
secondary id: B403201836842
nct id: NCT03835520
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to collect blood samples, as well as tumor tissue for genetic
      analysis. The collection of samples will allow the creation of a plasma bank. Targeted
      individuals are cancer patients of all types, treated with immunotherapy or targeted therapy.

      Immunotherapy or targeted agents will be administered according to standard of care and
      reimbursement modalities in Belgium. Targeted agents will be administered according to
      manufacturer's instructions.

      With the aim to identify predictive markers of response to treatment or possible resistance
      mechanism, the plasma samples and the tumor samples will be used for genetic analysis, for
      example but not limited to, whole exome sequencing. This may lead to the discovery of some
      germinal mutations implicated in other diseases than cancer.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: The trial will include patients with any type of cancer treated with one of the following regimens after signing of the patient's informed consent:
I: Molecular targeted agent
II: Immunotherapy
primary purpose: Treatment
masking: None (Open Label)
masking description: Masking and allocation tbc
measure: efficacy of treatment against Cancer
time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
description: Efficacy will be determined in terms of overall responses according to standard practice by the local investigator. Disease and response assessments are defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
measure: Overall survival (OS)
time frame: From date of randomization until the date of first documented progression assessed up to 120 months
description: Overall survival is defined as the time from the date of inclusion to the date of death from any cause or to the date of last follow-up (in exceptional cases where it is impossible to document the date of death). Every effort should be made to document the cause of death.
measure: Progression free survival
time frame: From date of randomization until the date of first documented progression , assessed up to 120 months
description: Progression free survival (PFS) will be measured from the date of inclusion to the date of progression or death, whatever the cause.
Progression will be defined according to the RECIST criteria.
measure: Objective tumor response
time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
description: Objective tumor response will be measured according to the RECIST 1.1 criteria.
arm group label: MOLECULAR TARGETED THERAPIES
arm group type: Experimental
description: Immunotherapy will be administered according to standard of care and reimbursement modalities in Belgium. Targeted agents will be administered according to manufacturer's instructions.
arm group label: IMMUNOTHERAPY
arm group type: Experimental
description: Immunotherapy will be administered according to standard of care and reimbursement modalities in Belgium.
intervention type: Drug
intervention name: Immunotherapeutic Agent
description: Immunotherapy will be administered according to standard of care and reimbursement modalities in Belgium.
arm group label: IMMUNOTHERAPY
intervention type: Drug
intervention name: Molecular Target
description: Targeted agents will be administered according to standard of care and reimbursement modalities in Belgium. Targeted agents will be administered according to manufacturer's instructions.
arm group label: MOLECULAR TARGETED THERAPIES
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Matthias Papier
phone: +32 2 764 78 49
email: matthias.papier@uclouvain.be
facility: 
status: Recruiting
contact: 
country: Belgium
responsible party type: Sponsor
mesh term: Immunomodulating Agents
sharing ipd: No