<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/NCT03280394</url>
  </required_header>
  <id_info>
    <org_study_id>IOSI-EMA003</org_study_id>
    <nct_id>NCT03280394</nct_id>
  </id_info>
  <brief_title>Liquid Biopsy in Mature B-cell Tumors</brief_title>
  <official_title>Prospective, Observational, Multi-centred, Non-interventional Research Project on Plasma Cell Free DNA Genotyping as a Tool to Inform Mature B-cell Tumor Management</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oncology Institute of Southern Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oncology Institute of Southern Switzerland</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study aims at assessing whether cell free DNA genotyping can improve the accuracy of&#xD;
      early prediction of cure in mature B-cell tumor patients and whether it represents an&#xD;
      accessible source of tumor DNA for the sensitive identification of genetic biomarkers that&#xD;
      refine the diagnostic workup, stratify prognosis and identify the emergence of&#xD;
      drug-resistance mutations during treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Clinical data and peripheral blood samples (20 ml in EDTA tubes and 20 ml in Cell-Free DNA&#xD;
      BCT tubes) will be collected during the clinico/laboratory visits that are planned as per&#xD;
      clinical routine at the time of mature B-cell tumor diagnosis, before treatment, at the time&#xD;
      of interim PET/CT, at the time of end of treatment PET/CT and at the time of disease relapse.&#xD;
&#xD;
      Clinical variables, international prognostic index, results of plasma cell free DNA&#xD;
      genotyping and of PET-CT will be analyzed descriptively.&#xD;
&#xD;
      The sensitivity, specificity, positive predictive value, negative predictive value and&#xD;
      accuracy of the compiled results of plasma cell free DNA genotyping and interim PET-CT (for&#xD;
      cHL and DLBCL), or plasma cell free DNA genotyping and baseline international prognostic&#xD;
      index (for FL and MCL) in identifying patients that are progression free for &gt;24 months after&#xD;
      first line therapy will be calculated and compared with those obtained by the sole interim&#xD;
      PET-CT (cHL and DLBCL) or the sole international prognostic index (FL, MCL).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2027</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2027</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>Accuracy of interim plasma cell free DNA genotyping for cHL patients</measure>
    <time_frame>24 months from treatment</time_frame>
    <description>Assessment of interim plasma cell free DNA genotyping accuracy in the identification of cured vs non cured patients in cHL (patients not progressed after 24 months)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Accuracy of interim plasma cell free DNA genotyping for DLBCL patients</measure>
    <time_frame>24 months from treatment</time_frame>
    <description>Assessment of interim plasma cell free DNA genotyping accuracy in the identification of cured vs non cured patients in DLBCL (patients not progressed after 24 months)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Accuracy of interim plasma cell free DNA genotyping for FL patients</measure>
    <time_frame>24 months from treatment</time_frame>
    <description>Assessment of interim plasma cell free DNA genotyping accuracy in the identification of patients in continuous complete remission at 24 months from first line treatment vs patients not in continuous complete remission at 24 months from first line treatment in FL and other indolent B-cell lymphoproliferative disorders</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Accuracy of interim plasma cell free DNA genotyping for MCL patients</measure>
    <time_frame>24 months from treatment</time_frame>
    <description>Assessment of interim plasma cell free DNA genotyping accuracy in the identification of patients in continuous complete remission at 24 months from first line treatment vs patients not in continuous complete remission at 24 months from first line treatment in MCL</description>
  </primary_outcome>
  <enrollment type="Anticipated">444</enrollment>
  <condition>Mature B-Cell Neoplasm</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Liquid Biopsy</intervention_name>
    <description>Assessing whether plasma cell free DNA improves the accuracy of early prediction of cure in mature B-cell tumor patients and whether it represents an accessible source of tumor DNA for the sensitive identification of genetic biomarkers that, at disease presentation, refine the diagnostic workup in mature B-cell tumor patients and, upon treatment, early identify the emergence of resistance mutations.</description>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples (20 ml in EDTA tubes and 20 ml in Cell-Free DNA BCT tubes)&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Male or female adults 18 years or older with a documented diagnosis of mature B-cell tumor&#xD;
        according to WHO 2008 criteria&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female adults 18 years or older&#xD;
&#xD;
          -  Documented diagnosis of mature B-cell tumor according to WHO 2008 criteria&#xD;
&#xD;
          -  Willing and able to comply with scheduled study procedures&#xD;
&#xD;
          -  Evidence of a signed 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>Davide Rossi, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oncology Institute of Southern Switzerland</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Davide Rossi, MD, PhD</last_name>
    <phone>+41 091 811 8540</phone>
    <email>davide.rossi@eoc.ch</email>
  </overall_contact>
  <location>
    <facility>
      <name>Institute of Oncology Research</name>
      <address>
        <city>Bellinzona</city>
        <state>Tessin</state>
        <zip>6500</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Davide Rossi, MD, PhD</last_name>
      <email>davide.rossi@eoc.ch</email>
    </contact>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>September 19, 2022</last_update_submitted>
  <last_update_submitted_qc>September 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oncology Institute of Southern Switzerland</investigator_affiliation>
    <investigator_full_name>Davide Rossi</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Liquid biopsy</keyword>
  <keyword>Classical Hodgkin Lymphoma</keyword>
  <keyword>Diffuse Large B Cell Lymphoma</keyword>
  <keyword>Follicular Lymphoma</keyword>
  <keyword>Mantle Cell Lymphoma</keyword>
  <keyword>Mutations</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma, B-Cell</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/NCT03280394
org study id: IOSI-EMA003
nct id: NCT03280394
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The study aims at assessing whether cell free DNA genotyping can improve the accuracy of
      early prediction of cure in mature B-cell tumor patients and whether it represents an
      accessible source of tumor DNA for the sensitive identification of genetic biomarkers that
      refine the diagnostic workup, stratify prognosis and identify the emergence of
      drug-resistance mutations during treatment.
Clinical data and peripheral blood samples (20 ml in EDTA tubes and 20 ml in Cell-Free DNA
      BCT tubes) will be collected during the clinico/laboratory visits that are planned as per
      clinical routine at the time of mature B-cell tumor diagnosis, before treatment, at the time
      of interim PET/CT, at the time of end of treatment PET/CT and at the time of disease relapse.

      Clinical variables, international prognostic index, results of plasma cell free DNA
      genotyping and of PET-CT will be analyzed descriptively.

      The sensitivity, specificity, positive predictive value, negative predictive value and
      accuracy of the compiled results of plasma cell free DNA genotyping and interim PET-CT (for
      cHL and DLBCL), or plasma cell free DNA genotyping and baseline international prognostic
      index (for FL and MCL) in identifying patients that are progression free for >24 months after
      first line therapy will be calculated and compared with those obtained by the sole interim
      PET-CT (cHL and DLBCL) or the sole international prognostic index (FL, MCL).
observational model: Cohort
time perspective: Prospective
measure: Accuracy of interim plasma cell free DNA genotyping for cHL patients
time frame: 24 months from treatment
description: Assessment of interim plasma cell free DNA genotyping accuracy in the identification of cured vs non cured patients in cHL (patients not progressed after 24 months)
measure: Accuracy of interim plasma cell free DNA genotyping for DLBCL patients
time frame: 24 months from treatment
description: Assessment of interim plasma cell free DNA genotyping accuracy in the identification of cured vs non cured patients in DLBCL (patients not progressed after 24 months)
measure: Accuracy of interim plasma cell free DNA genotyping for FL patients
time frame: 24 months from treatment
description: Assessment of interim plasma cell free DNA genotyping accuracy in the identification of patients in continuous complete remission at 24 months from first line treatment vs patients not in continuous complete remission at 24 months from first line treatment in FL and other indolent B-cell lymphoproliferative disorders
measure: Accuracy of interim plasma cell free DNA genotyping for MCL patients
time frame: 24 months from treatment
description: Assessment of interim plasma cell free DNA genotyping accuracy in the identification of patients in continuous complete remission at 24 months from first line treatment vs patients not in continuous complete remission at 24 months from first line treatment in MCL
intervention type: Diagnostic Test
intervention name: Liquid Biopsy
description: Assessing whether plasma cell free DNA improves the accuracy of early prediction of cure in mature B-cell tumor patients and whether it represents an accessible source of tumor DNA for the sensitive identification of genetic biomarkers that, at disease presentation, refine the diagnostic workup in mature B-cell tumor patients and, upon treatment, early identify the emergence of resistance mutations.
Blood samples (20 ml in EDTA tubes and 20 ml in Cell-Free DNA BCT tubes)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Davide Rossi, MD, PhD
role: Principal Investigator
affiliation: Oncology Institute of Southern Switzerland
last name: Davide Rossi, MD, PhD
phone: +41 091 811 8540
email: davide.rossi@eoc.ch
facility: 
status: Recruiting
contact: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: Oncology Institute of Southern Switzerland
investigator full name: Davide Rossi
investigator title: MD, PhD
mesh term: Lymphoma, B-Cell