<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/NCT04417803</url>
  </required_header>
  <id_info>
    <org_study_id>ROSSI 2020</org_study_id>
    <nct_id>NCT04417803</nct_id>
  </id_info>
  <brief_title>Interest of Individual Biomarkers From the Identification of Tumor Genotype by High-throughput Molecular Techniques</brief_title>
  <acronym>BIOLYMPH2020</acronym>
  <official_title>Interest of Individual Biomarkers From the Identification of Tumor Genotype in Plasma (ctDNA: Circulating Tumor DNA) by High-throughput Molecular Next Generation Techniques(CAPP Seq, PhAsE Seq, VIRCAPP-seq) in the Diagnosis and Personalized Management of Lymphomas in a Prospective Monocentric Cohort</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Dijon</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Lymphomas are the most common haemopathic malignancy. The 3 most common types are diffuse&#xD;
      large B-cell lymphoma (DLBCL), Hodgkin's lymphoma (HL) and follicular lymphoma (FL). In these&#xD;
      three subtypes, the treatment strategy is most often curative. The therapeutic strategy is&#xD;
      guided by PET (positron emission tomography), which optimises the risk-benefit balance&#xD;
      between the efficacy and toxicity of the treatment and makes it possible to limit the&#xD;
      intensity of treatment for good responders and to intensify the treatment of poor responders&#xD;
      with a worse prognosis. PET therefore plays a central role in the pre-therapeutic evaluation&#xD;
      of the disease and in the assessment of response to treatment. However, other complementary&#xD;
      approaches could improve characterization prior to initiating lymphoma t-treatment and&#xD;
      individual patient management during treatment and beyond. In DLBCL, it has been shown that&#xD;
      the risk of relapse of good and bad responders is decreased by combining the PET response&#xD;
      with a reduction in the amount of tumor DNA (ctDNA) in the blood, i.e. the genetic program of&#xD;
      lymphoma cells that circulates freely in the blood. This evaluation of ctDNA has been made&#xD;
      possible by the development of innovative techniques such as Next Generation Sequencing&#xD;
      (NGS). In lymphomas, several approaches have been developed, the most sensitive and promising&#xD;
      being CAPP-Seq (CAncer Personalized Profiling by deep Sequencing) developed at Stanford&#xD;
      University.&#xD;
&#xD;
      It is therefore useful to study the description of ctDNA in the 3 types of lymphomas and to&#xD;
      analyse the progression profiles under treatment by trying to establish the major potential&#xD;
      usefulness of these techniques: modifying treatment in case of poor response based on ctDNA&#xD;
      +/- and PET, detecting relapses earlier than at present in patients without any other sign of&#xD;
      relapse (clinical, blood or PET).&#xD;
&#xD;
      The project presented here aims to build a collection of plasma samples taken before&#xD;
      treatment, during treatment and during the first 2 years of follow-up in patients with one of&#xD;
      the 3 most frequent types of lymphoma and undergoing curative treatment. The hypothesis is&#xD;
      that sequential evaluation of ctDNA could improve the individualized management of future&#xD;
      patients based on the results generated by the analyses of patients in this cohort.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 17, 2021</start_date>
  <completion_date type="Anticipated">May 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>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>biomarkers</measure>
    <time_frame>through study completion, an average of 7 years</time_frame>
    <description>identification of individual plasma biomarkers, based on cfDNA (cell-free DNA), by high-throughput sequencing of circulating ctDNA tumor DNA</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>tumour mutation profile</measure>
    <time_frame>through study completion, an average of 7 years</time_frame>
    <description>Description of the tumour mutation profile using different molecular biology techniques (CAPP-seq, PHASE-seq, VIRCAPP-seq) by analysing circulating tumour DNA (ctDNA) from cfDNA</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">900</enrollment>
  <condition>Lymphomas</condition>
  <arm_group>
    <arm_group_label>diffuse large B-cell lymphoma</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>follicular lymphoma</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Hodgkin's lymphoma</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Blood sampling</intervention_name>
    <description>plasmatic sampling</description>
    <arm_group_label>Hodgkin's lymphoma</arm_group_label>
    <arm_group_label>diffuse large B-cell lymphoma</arm_group_label>
    <arm_group_label>follicular lymphoma</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Person who has not opposed to their inclusion in the trial&#xD;
&#xD;
          -  Confirmation of the diagnosis of one of the three lymphomas (DGLBL, LF or classic LH)&#xD;
             according to the WHO 2016 international classification (Smerdlow et al, 2016)&#xD;
&#xD;
          -  Patients not currently taking treatment for their haemopathy (or who have received&#xD;
             corticosteroid therapy alone within 14 days prior to the 1st sampling, dose limited to&#xD;
             500mg total)&#xD;
&#xD;
          -  Patients requiring systemic treatment within 30 days of screening&#xD;
&#xD;
          -  PET images available for pre-therapy and follow-up (mid-treatment, end of treatment)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Person subject to legal protection (curatorship, guardianship)&#xD;
&#xD;
          -  Person under partial judicial control&#xD;
&#xD;
          -  Pregnant, parturient or breastfeeding woman&#xD;
&#xD;
          -  Adult incapable or incapable of giving consent&#xD;
&#xD;
          -  Minor&#xD;
&#xD;
          -  Localized lymphoma treated by surgery and/or localized radiotherapy&#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>Olivier CASASNOVAS</last_name>
    <phone>0380295041</phone>
    <phone_ext>+33</phone_ext>
    <email>olivier.casasnovas@chu-dijon.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chu Dijon Bourgogne</name>
      <address>
        <city>Dijon</city>
        <zip>21000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Olivier Casasnovas</last_name>
      <phone>03.80.29.50.41</phone>
      <phone_ext>+33</phone_ext>
      <email>olivier.casasnovas@chu-dijon.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>December 7, 2021</last_update_submitted>
  <last_update_submitted_qc>December 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 22, 2021</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>Lymphoma</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/NCT04417803
org study id: ROSSI 2020
nct id: NCT04417803
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Lymphomas are the most common haemopathic malignancy. The 3 most common types are diffuse
      large B-cell lymphoma (DLBCL), Hodgkin's lymphoma (HL) and follicular lymphoma (FL). In these
      three subtypes, the treatment strategy is most often curative. The therapeutic strategy is
      guided by PET (positron emission tomography), which optimises the risk-benefit balance
      between the efficacy and toxicity of the treatment and makes it possible to limit the
      intensity of treatment for good responders and to intensify the treatment of poor responders
      with a worse prognosis. PET therefore plays a central role in the pre-therapeutic evaluation
      of the disease and in the assessment of response to treatment. However, other complementary
      approaches could improve characterization prior to initiating lymphoma t-treatment and
      individual patient management during treatment and beyond. In DLBCL, it has been shown that
      the risk of relapse of good and bad responders is decreased by combining the PET response
      with a reduction in the amount of tumor DNA (ctDNA) in the blood, i.e. the genetic program of
      lymphoma cells that circulates freely in the blood. This evaluation of ctDNA has been made
      possible by the development of innovative techniques such as Next Generation Sequencing
      (NGS). In lymphomas, several approaches have been developed, the most sensitive and promising
      being CAPP-Seq (CAncer Personalized Profiling by deep Sequencing) developed at Stanford
      University.

      It is therefore useful to study the description of ctDNA in the 3 types of lymphomas and to
      analyse the progression profiles under treatment by trying to establish the major potential
      usefulness of these techniques: modifying treatment in case of poor response based on ctDNA
      +/- and PET, detecting relapses earlier than at present in patients without any other sign of
      relapse (clinical, blood or PET).

      The project presented here aims to build a collection of plasma samples taken before
      treatment, during treatment and during the first 2 years of follow-up in patients with one of
      the 3 most frequent types of lymphoma and undergoing curative treatment. The hypothesis is
      that sequential evaluation of ctDNA could improve the individualized management of future
      patients based on the results generated by the analyses of patients in this cohort.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: biomarkers
time frame: through study completion, an average of 7 years
description: identification of individual plasma biomarkers, based on cfDNA (cell-free DNA), by high-throughput sequencing of circulating ctDNA tumor DNA
measure: tumour mutation profile
time frame: through study completion, an average of 7 years
description: Description of the tumour mutation profile using different molecular biology techniques (CAPP-seq, PHASE-seq, VIRCAPP-seq) by analysing circulating tumour DNA (ctDNA) from cfDNA
arm group label: diffuse large B-cell lymphoma
arm group type: Other
arm group label: follicular lymphoma
arm group type: Other
arm group label: Hodgkin's lymphoma
arm group type: Other
intervention type: Biological
intervention name: Blood sampling
description: plasmatic sampling
arm group label: Hodgkin's lymphoma
arm group label: diffuse large B-cell lymphoma
arm group label: follicular lymphoma
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Olivier CASASNOVAS
phone: 0380295041
phone ext: +33
email: olivier.casasnovas@chu-dijon.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Lymphoma