<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/NCT03797170</url>
  </required_header>
  <id_info>
    <org_study_id>Oncopassport</org_study_id>
    <secondary_id>RF-2016-02363730</secondary_id>
    <nct_id>NCT03797170</nct_id>
  </id_info>
  <brief_title>Design of New Personalized Therapeutic Approaches for Diffuse Large B-cell Lymphoma</brief_title>
  <official_title>Design of New Personalized Therapeutic Approaches for Diffuse Large B-cell Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Bologna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Bologna</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 Europe diffuse large B-cell lymphoma (DLBCL) is a rare disease whereas in Italy it is not.&#xD;
      Approximately 40% of DLBCL patients has refractory disease or will relapse after initial&#xD;
      response. In onco-hematology, a role for gut microbiota (GM) in mediating immune activation&#xD;
      in response to chemotherapy, has been suggested. In this scenario, the Investigators&#xD;
      hypothesized that GM could play an important role in DLBCL prognosis and response to&#xD;
      treatment, establishing a connection between lifestyle and clinical response. The project is&#xD;
      aimed to the study of the functional GM layout in association with specific patterns of&#xD;
      treatment response in de novo DLBCL undergoing standard first line chemo-immunotherapy.&#xD;
      Results may build the scientific basis to design new and personalized intervention strategies&#xD;
      (both in treatment approach and in life-style recommendations), to enhance clinical response&#xD;
      and reduction of disease refractoriness through modulation of the gut microbial ecosystem.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 2, 2019</start_date>
  <completion_date type="Anticipated">December 20, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 20, 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>GM dysbiosis assessment (bacterial DNA of gut microbiota in all patients)</measure>
    <time_frame>18 months</time_frame>
    <description>dysbiosis index: the dysbiosis index relies on the calculation of the weighted ratio between health-promoting and disease-associated GM components&#xD;
relative abundance of GM biomarkers of an eubiotic GM state: all GM dysbiotic states share a common feature, i.e. the depletion of strategic health-promoting GM components such as Faecalibacterium prausnitzii and Lachnospiraceae. Thus, a GM dysbiotic state is determined by the assessment of a reduction of the abundance of these GM biomarkers below the thresholds characteristic of an eubiotc GM state.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Response to therapy</measure>
    <time_frame>2 years</time_frame>
    <description>Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted as long as it is PET negative and all lymph nodes and nodal masses must have regressed on CT to normal size ( 1.5 cm in their greatest transverse diameter for nodes 1.5 cm before therapy).</description>
  </secondary_outcome>
  <enrollment type="Actual">50</enrollment>
  <condition>Diffuse Large B Cell Lymphoma</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Gut microbiota samples</intervention_name>
    <description>Gut microbiota analysis from diagnosis to follow up after first line-chemo-immuntherapy</description>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Gut microbiota&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients affected by diffuse large B-cell lymphoma (DLBCL) undergoing therapy with&#xD;
        front-line R-CHOP (rituximab-cyclophosphamide, doxorubicin, vincristine, prednisone).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥18 years&#xD;
&#xD;
          2. Patients affected by histologically confirmed diffuse large B-cell lymphoma&#xD;
&#xD;
          3. Patients amenable for therapy with RCHOP (RCHOP is the standard first line therapy for&#xD;
             DLBCL and it scheduled regardless of participation in present study).&#xD;
&#xD;
          4. Patients must provide written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Concomitant second malignancy, other than lymphoma.&#xD;
&#xD;
          2. Previous anti-lymphoma therapy.&#xD;
&#xD;
          3. Pregnancy or breastfeeding.&#xD;
&#xD;
          4. Evidence of significant, uncontrolled concomitant diseases that could affect&#xD;
             compliance with the protocol or interpretation of results.&#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>Pier Luigi L Zinzani, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of Hematology &quot;L. e A. Seràgnoli&quot;, University of Bologna</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)</name>
      <address>
        <city>Meldola</city>
        <state>FC</state>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute Of Hematology &quot;Seràgnoli&quot;</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>February 6, 2023</last_update_submitted>
  <last_update_submitted_qc>February 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Bologna</investigator_affiliation>
    <investigator_full_name>Pier Luigi Zinzani</investigator_full_name>
    <investigator_title>Full Professor, MD (Hematologist)</investigator_title>
  </responsible_party>
  <keyword>RCHOP</keyword>
  <keyword>first line</keyword>
  <keyword>microbiota</keyword>
  <keyword>response</keyword>
  <keyword>disease control</keyword>
  <keyword>therapy toxicity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, B-Cell</mesh_term>
    <mesh_term>Lymphoma, Large B-Cell, Diffuse</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03797170
org study id: Oncopassport
secondary id: RF-2016-02363730
nct id: NCT03797170
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In Europe diffuse large B-cell lymphoma (DLBCL) is a rare disease whereas in Italy it is not.
      Approximately 40% of DLBCL patients has refractory disease or will relapse after initial
      response. In onco-hematology, a role for gut microbiota (GM) in mediating immune activation
      in response to chemotherapy, has been suggested. In this scenario, the Investigators
      hypothesized that GM could play an important role in DLBCL prognosis and response to
      treatment, establishing a connection between lifestyle and clinical response. The project is
      aimed to the study of the functional GM layout in association with specific patterns of
      treatment response in de novo DLBCL undergoing standard first line chemo-immunotherapy.
      Results may build the scientific basis to design new and personalized intervention strategies
      (both in treatment approach and in life-style recommendations), to enhance clinical response
      and reduction of disease refractoriness through modulation of the gut microbial ecosystem.
observational model: Cohort
time perspective: Prospective
measure: GM dysbiosis assessment (bacterial DNA of gut microbiota in all patients)
time frame: 18 months
description: dysbiosis index: the dysbiosis index relies on the calculation of the weighted ratio between health-promoting and disease-associated GM components
relative abundance of GM biomarkers of an eubiotic GM state: all GM dysbiotic states share a common feature, i.e. the depletion of strategic health-promoting GM components such as Faecalibacterium prausnitzii and Lachnospiraceae. Thus, a GM dysbiotic state is determined by the assessment of a reduction of the abundance of these GM biomarkers below the thresholds characteristic of an eubiotc GM state.
measure: Response to therapy
time frame: 2 years
description: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted as long as it is PET negative and all lymph nodes and nodal masses must have regressed on CT to normal size ( 1.5 cm in their greatest transverse diameter for nodes 1.5 cm before therapy).
intervention type: Other
intervention name: Gut microbiota samples
description: Gut microbiota analysis from diagnosis to follow up after first line-chemo-immuntherapy
Gut microbiota
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pier Luigi L Zinzani, Professor
role: Principal Investigator
affiliation: Institute of Hematology "L. e A. Seràgnoli", University of Bologna
facility: 
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Bologna
investigator full name: Pier Luigi Zinzani
investigator title: Full Professor, MD (Hematologist)
mesh term: Lymphoma
mesh term: Lymphoma, B-Cell
mesh term: Lymphoma, Large B-Cell, Diffuse
sharing ipd: Undecided