<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/NCT03040206</url>
  </required_header>
  <id_info>
    <org_study_id>nodal PTCL</org_study_id>
    <nct_id>NCT03040206</nct_id>
  </id_info>
  <brief_title>Risk Stratification of Nodal PTCL</brief_title>
  <official_title>Multicenter Study to Assess the Prognostic Significances of NCCN-IPI and Post-treatment PET Results in Patients With Newly Diagnosed Nodal PTCL</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chonbuk National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Chonnam National University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kyungpook National University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Keimyung University Dongsan Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Korea University Anam Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Korea University Guro Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dong-A University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pusan National University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Yeungnam University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Inje University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chungnam National University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chonbuk National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study is to investigate the prognostic significance of enhanced International Prognostic&#xD;
      Index (NCCN-IPI) and post-treatment PET results in patients with newly diagnosed nodal&#xD;
      peripheral T-cell lymphoma (PTCL), and establish a risk stratification model for nodal PTCL&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>progression-free survival</measure>
    <time_frame>5 year</time_frame>
    <description>Time between the date of diagnosis and any kinds of death or disease relapse/progrression</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>5 year</time_frame>
    <description>Time between the date of diagnosis and any kinds of death</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">405</enrollment>
  <condition>Peripheral T-Cell Lymphoma, Not Otherwise Specified</condition>
  <condition>Angioimmunoblastic T-cell Lymphoma</condition>
  <condition>Anaplastic Large Cell Lymphoma, ALK-negative</condition>
  <arm_group>
    <arm_group_label>Nodal PTCL</arm_group_label>
    <description>newly-diagnosed, pathologically-proven nodal PTCLs (PTCL, NOS; Angioimmunblastic T-cell lymphoma; anaplastic large cell lymphoma [ALCL], anaplastic lymphoma kinase [ALK]-negative) between January 1, 2005 and Jun 30, 2016&#xD;
initially treated with curative intent&#xD;
Standard PET or PET-CT data available at the time of diagnosis and at the end of primary treatment</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Newly diagnosed, pathologically prove nodal PTCL (PTCN-NOS; AITL; ALCL, ALK-negative)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with nodal PTCLs (PTCL, NOS; Angioimmunblastic T-cell lymphoma;&#xD;
             anaplastic large cell lymphoma [ALCL], anaplastic lymphoma kinase [ALK]-negative)&#xD;
&#xD;
          -  Patients diagnosed with between January 1, 2004 and April 30, 2016&#xD;
&#xD;
          -  initially treated with curative intent&#xD;
&#xD;
          -  Patients with standard 18F-fluorodeoxyglucose (FDG) PET or PET-CT data at the time of&#xD;
             diagnosis and at the end of primary treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with extranodal PTCLs, including followings (extranodal NK/T-cell&#xD;
             lymphoma, nasal type; enteropathy-associated T-cell lymphoma; hepatosplenic T-cell&#xD;
             lymphoma; subcutaneous panniculitis-like T-cell lymphoma; EBV-positive T-cell&#xD;
             lymphoproliferative childhood disorders, and primary cutaneous lymphomas)&#xD;
&#xD;
          -  Patients with ALCL-ALK+&#xD;
&#xD;
          -  Patients who do not have 18F-FDG PET or PET-CT data either at diagnosis or at the end&#xD;
             of treatment available for review&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Ho-Young Yhim</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chonbuk National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chonbuk Nationla University Hospital</name>
      <address>
        <city>Jeonju</city>
        <zip>561-712</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>August 5, 2019</last_update_submitted>
  <last_update_submitted_qc>August 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chonbuk National University Hospital</investigator_affiliation>
    <investigator_full_name>Ho-Young Yhim</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, T-Cell</mesh_term>
    <mesh_term>Lymphoma, T-Cell, Peripheral</mesh_term>
    <mesh_term>Lymphoma, Large-Cell, Anaplastic</mesh_term>
    <mesh_term>Immunoblastic Lymphadenopathy</mesh_term>
  </condition_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/NCT03040206
org study id: nodal PTCL
nct id: NCT03040206
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is to investigate the prognostic significance of enhanced International Prognostic
      Index (NCCN-IPI) and post-treatment PET results in patients with newly diagnosed nodal
      peripheral T-cell lymphoma (PTCL), and establish a risk stratification model for nodal PTCL
      patients.
observational model: Cohort
time perspective: Retrospective
measure: progression-free survival
time frame: 5 year
description: Time between the date of diagnosis and any kinds of death or disease relapse/progrression
measure: overall survival
time frame: 5 year
description: Time between the date of diagnosis and any kinds of death
arm group label: Nodal PTCL
description: newly-diagnosed, pathologically-proven nodal PTCLs (PTCL, NOS; Angioimmunblastic T-cell lymphoma; anaplastic large cell lymphoma [ALCL], anaplastic lymphoma kinase [ALK]-negative) between January 1, 2005 and Jun 30, 2016
initially treated with curative intent
Standard PET or PET-CT data available at the time of diagnosis and at the end of primary treatment
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Ho-Young Yhim
role: Principal Investigator
affiliation: Chonbuk National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Chonbuk National University Hospital
investigator full name: Ho-Young Yhim
investigator title: Assistant professor
mesh term: Lymphoma
mesh term: Lymphoma, T-Cell
mesh term: Lymphoma, T-Cell, Peripheral
mesh term: Lymphoma, Large-Cell, Anaplastic
mesh term: Immunoblastic Lymphadenopathy
sharing ipd: No