<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/NCT03000738</url>
  </required_header>
  <id_info>
    <org_study_id>PUMCH-1163</org_study_id>
    <nct_id>NCT03000738</nct_id>
  </id_info>
  <brief_title>The Value and Mechanisms for Monocytes Subpopulations in Predicting the Prognosis of Lymphomas</brief_title>
  <official_title>The Value and Potential Mechanisms for Monocytes Subpopulations in Predicting the Prognosis of Non-Hodgkin Lymphomas.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether the CD16- monocyte/CD16+ monocyte ratio&#xD;
      could help predict the prognosis of DLBCL and PTCL.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators plan to prospectively involve 100 non-hodgekin lymphoma patients, including&#xD;
      50 diffuse large B cell lymphomas and 50 peripheral T cell lymphomas without previous&#xD;
      treatment from Peking Union Medical College Hospital.&#xD;
&#xD;
      The following parameters were collected: age, sex, subtype, Eastern Cooperative Oncology&#xD;
      Group (ECOG) performance status (PS), Ann Arbor stage (I-IV), presence of B symptoms, number&#xD;
      and type of involved sites, prognostic index including International Prognostic Index (IPI)&#xD;
      for DLBCLand PIT for PTCL based on medical record review.&#xD;
&#xD;
      All patients would have regular treatment and follow up in PUMCH. During the follow up,&#xD;
      treatment response was evaluated by enhanced computed tomography or PET-CT.&#xD;
&#xD;
      The peripheral blood would be collected. The Cytodiff flow cytometric technique would be used&#xD;
      to test 16 leukocyte subpopulations from peripheral blood at the time of diagnosis, interim&#xD;
      of treatment, end of treatment, 1 year follow-up, 1.5 year of follow-up, 2 year of follow up,&#xD;
      3 year of follow-up and disease progression.&#xD;
&#xD;
      Progression-free survival (PFS) and overall survival (OS) would be estimated using the&#xD;
      Kaplan-Meier method and two-tailed log-rank test.The Cox proportional hazards model would&#xD;
      evaluate prognostic factors for OS and PFS. Specificity, sensitivity and cut-off would be&#xD;
      established using time-dependent receiver operating characteristic (ROC) curve analysis. Area&#xD;
      under curve (AUC) values &gt;0.7 indicate that the parameter can be used for diagnosis, with&#xD;
      values &gt;0.9 indicating high clinical accuracy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</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>overall survival</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>progression free survival</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Lymphoma,Non-Hodgkin</condition>
  <condition>Diffuse Large B Cell Lymphoma</condition>
  <condition>Peripheral T-Cell Lymphoma</condition>
  <arm_group>
    <arm_group_label>non-hodgekin lymphoma</arm_group_label>
    <description>100 non-hodgekin lymphoma patients (age &gt;=18y) without previous treatment would be administered, including 50 DLBCLs and 50 PTCLs.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      peripheral blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients diagnosed to be diffuse large B cell lymphoma or peripheral T cell lymphoma&#xD;
        without any previous treatment in Peking Union Medical College Hospital (PUMCH) would be&#xD;
        included.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. pathologically confirmed diffuse large B cell lymphoma (DLBCL nos, PCNSL, ALK+ DLBCL,&#xD;
             DLBCL/BL) or peripheral T cell lymphoma (AITL, ALCL, PTCL nos, NK/T nasal type, EATL,&#xD;
             HSTL)&#xD;
&#xD;
          2. no treatment before&#xD;
&#xD;
          3. hCG(-)&#xD;
&#xD;
          4. 18 years old to 80 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. other tumors&#xD;
&#xD;
          2. severe infections&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daobin Zhou, MD</last_name>
    <role>Study Director</role>
    <affiliation>Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Wei Zhang</last_name>
    <phone>+86-010-69151235</phone>
    <email>vv1223@vip.sina.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Xiao Han</last_name>
    <phone>+86 18618191308</phone>
    <email>xiaoer020@vip.sina.com</email>
  </overall_contact_backup>
  <reference>
    <citation>Wilcox RA, Ristow K, Habermann TM, Inwards DJ, Micallef IN, Johnston PB, Colgan JP, Nowakowski GS, Ansell SM, Witzig TE, Markovic SN, Porrata L. The absolute monocyte and lymphocyte prognostic score predicts survival and identifies high-risk patients in diffuse large-B-cell lymphoma. Leukemia. 2011 Sep;25(9):1502-9. doi: 10.1038/leu.2011.112. Epub 2011 May 24.</citation>
    <PMID>21606957</PMID>
  </reference>
  <reference>
    <citation>Ziegler-Heitbrock L, Ancuta P, Crowe S, Dalod M, Grau V, Hart DN, Leenen PJ, Liu YJ, MacPherson G, Randolph GJ, Scherberich J, Schmitz J, Shortman K, Sozzani S, Strobl H, Zembala M, Austyn JM, Lutz MB. Nomenclature of monocytes and dendritic cells in blood. Blood. 2010 Oct 21;116(16):e74-80. doi: 10.1182/blood-2010-02-258558. Epub 2010 Jul 13.</citation>
    <PMID>20628149</PMID>
  </reference>
  <reference>
    <citation>Subimerb C, Pinlaor S, Lulitanond V, Khuntikeo N, Okada S, McGrath MS, Wongkham S. Circulating CD14(+) CD16(+) monocyte levels predict tissue invasive character of cholangiocarcinoma. Clin Exp Immunol. 2010 Sep;161(3):471-9. doi: 10.1111/j.1365-2249.2010.04200.x.</citation>
    <PMID>20636398</PMID>
  </reference>
  <reference>
    <citation>Heagerty PJ, Lumley T, Pepe MS. Time-dependent ROC curves for censored survival data and a diagnostic marker. Biometrics. 2000 Jun;56(2):337-44. doi: 10.1111/j.0006-341x.2000.00337.x.</citation>
    <PMID>10877287</PMID>
  </reference>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>March 30, 2017</last_update_submitted>
  <last_update_submitted_qc>March 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CD16- monocyte/CD16+ monocyte ratio</keyword>
  <keyword>CytoDiff flow cytometric system</keyword>
  <keyword>Diffuse Large B Cell Lymphoma</keyword>
  <keyword>Peripheral T-Cell Lymphoma</keyword>
  <keyword>prognosis</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, T-Cell</mesh_term>
    <mesh_term>Lymphoma, T-Cell, Peripheral</mesh_term>
    <mesh_term>Lymphoma, Large B-Cell, Diffuse</mesh_term>
    <mesh_term>Lymphoma, Non-Hodgkin</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/NCT03000738
org study id: PUMCH-1163
nct id: NCT03000738
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine whether the CD16- monocyte/CD16+ monocyte ratio
      could help predict the prognosis of DLBCL and PTCL.
The investigators plan to prospectively involve 100 non-hodgekin lymphoma patients, including
      50 diffuse large B cell lymphomas and 50 peripheral T cell lymphomas without previous
      treatment from Peking Union Medical College Hospital.

      The following parameters were collected: age, sex, subtype, Eastern Cooperative Oncology
      Group (ECOG) performance status (PS), Ann Arbor stage (I-IV), presence of B symptoms, number
      and type of involved sites, prognostic index including International Prognostic Index (IPI)
      for DLBCLand PIT for PTCL based on medical record review.

      All patients would have regular treatment and follow up in PUMCH. During the follow up,
      treatment response was evaluated by enhanced computed tomography or PET-CT.

      The peripheral blood would be collected. The Cytodiff flow cytometric technique would be used
      to test 16 leukocyte subpopulations from peripheral blood at the time of diagnosis, interim
      of treatment, end of treatment, 1 year follow-up, 1.5 year of follow-up, 2 year of follow up,
      3 year of follow-up and disease progression.

      Progression-free survival (PFS) and overall survival (OS) would be estimated using the
      Kaplan-Meier method and two-tailed log-rank test.The Cox proportional hazards model would
      evaluate prognostic factors for OS and PFS. Specificity, sensitivity and cut-off would be
      established using time-dependent receiver operating characteristic (ROC) curve analysis. Area
      under curve (AUC) values >0.7 indicate that the parameter can be used for diagnosis, with
      values >0.9 indicating high clinical accuracy.
observational model: Cohort
time perspective: Prospective
measure: overall survival
time frame: 3 years
measure: progression free survival
time frame: 3 years
arm group label: non-hodgekin lymphoma
description: 100 non-hodgekin lymphoma patients (age >=18y) without previous treatment would be administered, including 50 DLBCLs and 50 PTCLs.
peripheral blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Daobin Zhou, MD
role: Study Director
affiliation: Peking Union Medical College Hospital
last name: Wei Zhang
phone: +86-010-69151235
email: vv1223@vip.sina.com
last name: Xiao Han
phone: +86 18618191308
email: xiaoer020@vip.sina.com
citation: Wilcox RA, Ristow K, Habermann TM, Inwards DJ, Micallef IN, Johnston PB, Colgan JP, Nowakowski GS, Ansell SM, Witzig TE, Markovic SN, Porrata L. The absolute monocyte and lymphocyte prognostic score predicts survival and identifies high-risk patients in diffuse large-B-cell lymphoma. Leukemia. 2011 Sep;25(9):1502-9. doi: 10.1038/leu.2011.112. Epub 2011 May 24.
PMID: 21606957
citation: Ziegler-Heitbrock L, Ancuta P, Crowe S, Dalod M, Grau V, Hart DN, Leenen PJ, Liu YJ, MacPherson G, Randolph GJ, Scherberich J, Schmitz J, Shortman K, Sozzani S, Strobl H, Zembala M, Austyn JM, Lutz MB. Nomenclature of monocytes and dendritic cells in blood. Blood. 2010 Oct 21;116(16):e74-80. doi: 10.1182/blood-2010-02-258558. Epub 2010 Jul 13.
PMID: 20628149
citation: Subimerb C, Pinlaor S, Lulitanond V, Khuntikeo N, Okada S, McGrath MS, Wongkham S. Circulating CD14(+) CD16(+) monocyte levels predict tissue invasive character of cholangiocarcinoma. Clin Exp Immunol. 2010 Sep;161(3):471-9. doi: 10.1111/j.1365-2249.2010.04200.x.
PMID: 20636398
citation: Heagerty PJ, Lumley T, Pepe MS. Time-dependent ROC curves for censored survival data and a diagnostic marker. Biometrics. 2000 Jun;56(2):337-44. doi: 10.1111/j.0006-341x.2000.00337.x.
PMID: 10877287
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, B-Cell
mesh term: Lymphoma, T-Cell
mesh term: Lymphoma, T-Cell, Peripheral
mesh term: Lymphoma, Large B-Cell, Diffuse
mesh term: Lymphoma, Non-Hodgkin
sharing ipd: Undecided