<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/NCT02265497</url>
  </required_header>
  <id_info>
    <org_study_id>Relinfo</org_study_id>
    <nct_id>NCT02265497</nct_id>
  </id_info>
  <brief_title>Brazilian Network for Lymphoma Registry</brief_title>
  <acronym>Relinfo</acronym>
  <official_title>Brazilian Network for Lymphoma Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Claudio Gustavo Stefanoff</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Adriana Alves de Souza Scheliga</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Claudete Esteves Nogueira Pinto Klumb</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ricardo de Sá Bigni</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Luciana Wernersbach Pinto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Rocio Hassan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Isabele Avila Small</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Monik Mariano Pinto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cecilia Ferreira da Silva</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Instituto Nacional de Cancer, Brazil</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Currently there are no official data concerning incidence, progression and prognosis of&#xD;
      patients with lymphoma in Brazil.This project aims the establishment of a network of 12&#xD;
      Brazilian Institutions to implement a Lymphoma Registry (RELINFO) with the Brazilian National&#xD;
      Cancer Institute (INCA) as the Coordinating Center.We intend to develop and implement a&#xD;
      computerized system for data entry and information management of patients with lymphomas.&#xD;
      This will enable create a virtual registry of demographic, clinical, epidemiological,&#xD;
      histopathological, molecular, and therapeutic data. This clinical record must be linked to&#xD;
      histopathological and molecular diagnosis, allowing institutions that work in the context of&#xD;
      the public health system have access to new technologies for early cancer diagnosis.We expect&#xD;
      is that this record reliably portrays the scene of lymphomas in our state and will become a&#xD;
      management model that can be replicated at the national level. Thus, the implementation of&#xD;
      RELINFO will strengthen the multidisciplinary diagnosis, promote the standardization of&#xD;
      clinical record of patients with lymphomas and provide subsidies to cooperative research&#xD;
      projects between participating institutions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Data collection and management:&#xD;
&#xD;
      For data collection will use a common system for all institutions participating.We developed&#xD;
      a computerized tool that utilizes models of case report forms (CRF) and allows the inclusion&#xD;
      and management of clinical, epidemiological, histopathological and molecular data. The&#xD;
      clinical and laboratory data of patients included in RELINFO will be obtained from the&#xD;
      hospital records. The integration of local databases allows constitute the RELINFO, conceived&#xD;
      as a virtual database of patients with lymphoma. The INCA as Coordinating Center is committed&#xD;
      to the security of this database.Standardization of diagnosisThis phase includes structuring&#xD;
      a technological platform for the standardization of histopathologic diagnosis (establishing&#xD;
      common routines in hematopathology) and the incorporation of molecular methods in the&#xD;
      diagnosis of lymphoma.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>24 Months</target_duration>
  <primary_outcome>
    <measure>rate of incidence of lymphomas in Brazil</measure>
    <time_frame>6 years</time_frame>
    <description>Identify the current situation of lymphomas, through the deployment of a Lymphoma Registry in cancer treatment centers of Rio de Janeiro, Brazil</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>epidemiological characterization of lymphomas in Brazil</measure>
    <time_frame>6 years</time_frame>
    <description>description of demographic, clinical, epidemiological, histopathological, molecular, and therapeutic data of lymphoma patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>establishing common routines in hematopathology</measure>
    <time_frame>6 years</time_frame>
    <description>Structure a technology platform that allows the standardization of histopathological diagnosis and the incorporation of molecular methods in the diagnosis of lymphoma.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">550</enrollment>
  <condition>Lymphoma</condition>
  <arm_group>
    <arm_group_label>Hodgkin's or non-Hodgkin lymphoma</arm_group_label>
    <description>All patients with diagnoses of Hodgkin's or non-Hodgkin lymphoma with available with available clinical, histopathology and treatment data.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All patients with diagnosis of Hodgkin's or non-Hodgkin lymphoma with available with&#xD;
        available clinical, histopathology and treatment data.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients (adult or child) with diagnosis of Hodgkin's or non-Hodgkin lymphoma with&#xD;
             available with available clinical, histopathology and treatment data&#xD;
&#xD;
          -  Patient enrolled on study sites included on this project&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients (adult or child) with other diagnoses of cancer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claudio Gustavo Stefanoff, Doctor</last_name>
    <role>Study Director</role>
    <affiliation>Instituto Nacional de Cancer, Brazil</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Claudio Gustavo Stefanoff, doctor</last_name>
    <phone>+55 21 32076541</phone>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Cecilia F Silva, Master</last_name>
    <phone>+55 21 32076601</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Brazilian National Cancer Institute - INCA/ Ministry Of HealthClinical Research Department</name>
      <address>
        <city>Rio de Janeiro</city>
        <state>RJ</state>
        <zip>20231-050</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Claudio Gustavo Stefanoof, Doctor</last_name>
      <phone>+55 21 32076541</phone>
    </contact>
    <contact_backup>
      <last_name>Adriana A Scheliga, Master</last_name>
      <phone>+55 21 32076585</phone>
    </contact_backup>
    <investigator>
      <last_name>Adilson José Almeida</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Monica Praxedes</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Fernando M Pinto</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Rita Elizabete G Espariz</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Luciana Conti</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Glaucia Guasti</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Juliana G Musacchio</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Leonardo G Leite</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>September 18, 2014</study_first_submitted>
  <study_first_submitted_qc>October 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2014</study_first_posted>
  <last_update_submitted>August 15, 2017</last_update_submitted>
  <last_update_submitted_qc>August 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Instituto Nacional de Cancer, Brazil</investigator_affiliation>
    <investigator_full_name>Claudio Gustavo Stefanoff</investigator_full_name>
    <investigator_title>Claudio Gustavo Stefanoff</investigator_title>
  </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/NCT02265497
org study id: Relinfo
nct id: NCT02265497
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Currently there are no official data concerning incidence, progression and prognosis of
      patients with lymphoma in Brazil.This project aims the establishment of a network of 12
      Brazilian Institutions to implement a Lymphoma Registry (RELINFO) with the Brazilian National
      Cancer Institute (INCA) as the Coordinating Center.We intend to develop and implement a
      computerized system for data entry and information management of patients with lymphomas.
      This will enable create a virtual registry of demographic, clinical, epidemiological,
      histopathological, molecular, and therapeutic data. This clinical record must be linked to
      histopathological and molecular diagnosis, allowing institutions that work in the context of
      the public health system have access to new technologies for early cancer diagnosis.We expect
      is that this record reliably portrays the scene of lymphomas in our state and will become a
      management model that can be replicated at the national level. Thus, the implementation of
      RELINFO will strengthen the multidisciplinary diagnosis, promote the standardization of
      clinical record of patients with lymphomas and provide subsidies to cooperative research
      projects between participating institutions.
Data collection and management:

      For data collection will use a common system for all institutions participating.We developed
      a computerized tool that utilizes models of case report forms (CRF) and allows the inclusion
      and management of clinical, epidemiological, histopathological and molecular data. The
      clinical and laboratory data of patients included in RELINFO will be obtained from the
      hospital records. The integration of local databases allows constitute the RELINFO, conceived
      as a virtual database of patients with lymphoma. The INCA as Coordinating Center is committed
      to the security of this database.Standardization of diagnosisThis phase includes structuring
      a technological platform for the standardization of histopathologic diagnosis (establishing
      common routines in hematopathology) and the incorporation of molecular methods in the
      diagnosis of lymphoma.
observational model: Cohort
time perspective: Prospective
measure: rate of incidence of lymphomas in Brazil
time frame: 6 years
description: Identify the current situation of lymphomas, through the deployment of a Lymphoma Registry in cancer treatment centers of Rio de Janeiro, Brazil
measure: epidemiological characterization of lymphomas in Brazil
time frame: 6 years
description: description of demographic, clinical, epidemiological, histopathological, molecular, and therapeutic data of lymphoma patients
measure: establishing common routines in hematopathology
time frame: 6 years
description: Structure a technology platform that allows the standardization of histopathological diagnosis and the incorporation of molecular methods in the diagnosis of lymphoma.
arm group label: Hodgkin's or non-Hodgkin lymphoma
description: All patients with diagnoses of Hodgkin's or non-Hodgkin lymphoma with available with available clinical, histopathology and treatment data.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Claudio Gustavo Stefanoff, Doctor
role: Study Director
affiliation: Instituto Nacional de Cancer, Brazil
last name: Claudio Gustavo Stefanoff, doctor
phone: +55 21 32076541
last name: Cecilia F Silva, Master
phone: +55 21 32076601
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Brazil
responsible party type: Sponsor-Investigator
investigator affiliation: Instituto Nacional de Cancer, Brazil
investigator full name: Claudio Gustavo Stefanoff
investigator title: Claudio Gustavo Stefanoff
mesh term: Lymphoma