<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/NCT01704742</url>
  </required_header>
  <id_info>
    <org_study_id>WVU1411</org_study_id>
    <nct_id>NCT01704742</nct_id>
  </id_info>
  <brief_title>Prospective Study of Lymphoproliferative Diseases</brief_title>
  <official_title>A Prospective Clinicopathological Cohort Study of Lymphoproliferative Diseases at Kenyatta National Hospital in Nairobi, Kenya</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>West Virginia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kenyatta National Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>West Virginia University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will help researchers learn more about non-Hodgkin's lymphoma and Hodgkin's&#xD;
      lymphoma and how it is treated in Kenya. Researchers want to see if having certain viruses&#xD;
      like Epstein Barr Virus (EBV), Human Immunodeficiency Virus (HIV), and Kaposi's Sarcoma&#xD;
      Herpes Virus (KSHV) affects lymphoma. Patients in Kenya who agree to be in this study will&#xD;
      let the resesarchers look at their medical record, follow their normal cancer care, and have&#xD;
      blood drawn to look at different proteins and viruses. Researchers would also like to look at&#xD;
      part of the original tumor that was taken out of each patient. Some of these samples will be&#xD;
      stored at Kenyatta National Hospital and research will be done on them later. This study does&#xD;
      not involve any change in treatment, but only allows the study team to follow how a patient&#xD;
      in Kenya with lymphoma is treated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Comprehensive prospective cohort study of lymphoproliferative diseases in Nairobi, Kenya.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Protocol not considered a clinical trial for registration purposes; no subjects enrolled to&#xD;
    date pending further grant funding&#xD;
  </why_stopped>
  <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>To determine the spectrum and natural history of lymphoproliferative disorders in Nairobi, Kenya</measure>
    <time_frame>2.5 Years</time_frame>
    <description>To determine the spectrum and natural history of lymophoproliferative disorders in Nairobi, Kenya by prospectively recruiting subjects with biopsy-proven malignant lymphoma including non-Hodgkin's and Hodgkin's lymphoma regardless of age, sex and HIV-serostatus (cohort study), who are seen at the Kenyatta National Hospital for treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To perform a comprehensive clinicopathological study in these subjects.</measure>
    <time_frame>2.5 Years</time_frame>
    <description>To perform a comprehensive clinicopathological study in these subjects with complete virological, immunophenotypic, and molecular characterization of retrieved tumor tissues and peripheral blood samples for purposes of identifying prognostic and predictive biomarkers of clinical outcome (i.e. treatment response, freedom from disease progression, and overall survival) in which to begin to frame pragmatic, risk-adapted therapeutic interventions suitable for the resource constrained setting in sub-Saharan Africa.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Companion R01 proposal: Clinicopathological Cohort Study of EBV-Associated Lymphomas in Kenya</measure>
    <time_frame>To be submitted next 6 months to 1 year</time_frame>
    <description>Aim 1: Determine the tissue biomarkers of EBV infection in AIDS-related lymphomas (ARL) in Kenya&#xD;
Aim 2: Compare the pattern of EBV persistence in patients with EBV+ and EBV- lymphoma&#xD;
Aim 3: Determine predictors of treatment outcome in AIDS-related lymphomas (ARL)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Non-Hodgkin's Lymphoma</condition>
  <condition>Hodgkin's Lymphoma</condition>
  <arm_group>
    <arm_group_label>No treatment</arm_group_label>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Tumor tissue, blood plasma and serum upon consent and suitability of sample preparation.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients at Kenyatta National Hospital in Kenya being treated for non-Hodgkin's lymphoma or&#xD;
        Hodgkin's lymphoma.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All subjects regardless of age, sex or HIV serostatus must have biopsy-proven&#xD;
             non-Hodgkin's (NHL), including primary effusion lymphoma, Hodgkin's lymphoma (HD) or&#xD;
             other lymphoproliferative disorder (e.g., Castleman's disease) with measurable or&#xD;
             evaluable stage I through IV disease.&#xD;
&#xD;
        [Note: Lymphomas will be categorized on the basis of current WHO classification scheme, but&#xD;
        it is recognized that initial pathological categorization at time of study enrollment will&#xD;
        more than likely be classified or graded as low-, intermediate-, or high-grade lymphoma by&#xD;
        Working Formulation criteria. This is the current standard of practice in Kenya.]&#xD;
&#xD;
          -  All subjects must receive some form of systemic chemotherapy. Subjects not receiving&#xD;
             chemotherapy of any kind are not eligible. Subjects must not have had any prior&#xD;
             chemotherapy for lymphoma.&#xD;
&#xD;
          -  Subjects may have received prior radiotherapy for localized stage I or stage II&#xD;
             disease that is clearly documented to have progressed beyond initial radiotherapy&#xD;
             ports.&#xD;
&#xD;
          -  All subjects must give written informed consent to participate on study. In Kenya, a&#xD;
             child is considered &lt; 18 years of age and an adult ≥ 18 years of age. All children&#xD;
             will have their parental or legal guardian provide consent.. Children between the ages&#xD;
             of 7 and &lt; 18 years old should be given the opportunity to provide their assent. For&#xD;
             children between the ages of 7 and 11 years old this should be done using the parental&#xD;
             consent form assent statement. For children &gt; 11 years old assent should be documented&#xD;
             using the IRB approved assent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who do not fulfill the criteria as listed in Sections 3.1.1 through 3.1.4 are&#xD;
             ineligible.&#xD;
&#xD;
          -  Subjects who received prior chemotherapy (i.e., first-line treatment) or are not&#xD;
             receiving any chemotherapy for their non-Hodgkin's (NHL) or Hodgkin's lymphoma (HD)&#xD;
             are ineligible.&#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>Scot C Remick, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>West Virginia University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Walter O Mwanda, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kenyatta National Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>West Virginia University Mary Babb Randolph Cancer Center</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kenyatta National Hospital (University of Nairobi)</name>
      <address>
        <city>Nairobi</city>
        <zip>00202</zip>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Kenya</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4. Erratum In: CA Cancer J Clin. 2011 Mar-Apr;61(2):134.</citation>
    <PMID>21296855</PMID>
  </reference>
  <reference>
    <citation>World Health Organization. Cancer. Fact Sheet No. 297, February 2011. Available at http://www.who.int/mediacentre/factsheets /fs297/en/index.html. Accessioned March 28, 2011.</citation>
  </reference>
  <reference>
    <citation>World Health Organization. The Global Burden of Disease: 2004 Update. Geneva: WHO, 2008.</citation>
  </reference>
  <reference>
    <citation>Ferlay J, Shin HR, Bray F, Forman D, Mathers C, and Parkin DM. Globocan 2008: cancer incidence and mortality worldwide. Lyon: International Agency for Research on Cancer, 2010. Available at: http://www.iarc/fr/. Accessioned March 28, 2011.</citation>
  </reference>
  <reference>
    <citation>Remick SC. Responding to the global cancer burden through partnerships. In: Am. Soc. Clin. Oncol. Ed. Book 2009; 670-4.</citation>
  </reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <last_update_submitted>November 4, 2016</last_update_submitted>
  <last_update_submitted_qc>November 4, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 8, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Non-Hodgkin's Lymphoma</keyword>
  <keyword>Hodgkin's Lymphoma</keyword>
  <keyword>Kenya</keyword>
  <keyword>Epstein Barr Virus (EBV)</keyword>
  <keyword>Human Immunodeficiency Virus (HIV)</keyword>
  <keyword>Kaposi's Sarcoma Herpes Virus (KSHV)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, Non-Hodgkin</mesh_term>
    <mesh_term>Hodgkin Disease</mesh_term>
    <mesh_term>Lymphoproliferative Disorders</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/NCT01704742
org study id: WVU1411
nct id: NCT01704742
lead sponsor: 
collaborator: 
has dmc: No
This study will help researchers learn more about non-Hodgkin's lymphoma and Hodgkin's
      lymphoma and how it is treated in Kenya. Researchers want to see if having certain viruses
      like Epstein Barr Virus (EBV), Human Immunodeficiency Virus (HIV), and Kaposi's Sarcoma
      Herpes Virus (KSHV) affects lymphoma. Patients in Kenya who agree to be in this study will
      let the resesarchers look at their medical record, follow their normal cancer care, and have
      blood drawn to look at different proteins and viruses. Researchers would also like to look at
      part of the original tumor that was taken out of each patient. Some of these samples will be
      stored at Kenyatta National Hospital and research will be done on them later. This study does
      not involve any change in treatment, but only allows the study team to follow how a patient
      in Kenya with lymphoma is treated.
Comprehensive prospective cohort study of lymphoproliferative diseases in Nairobi, Kenya.
observational model: Cohort
time perspective: Prospective
measure: To determine the spectrum and natural history of lymphoproliferative disorders in Nairobi, Kenya
time frame: 2.5 Years
description: To determine the spectrum and natural history of lymophoproliferative disorders in Nairobi, Kenya by prospectively recruiting subjects with biopsy-proven malignant lymphoma including non-Hodgkin's and Hodgkin's lymphoma regardless of age, sex and HIV-serostatus (cohort study), who are seen at the Kenyatta National Hospital for treatment.
measure: To perform a comprehensive clinicopathological study in these subjects.
time frame: 2.5 Years
description: To perform a comprehensive clinicopathological study in these subjects with complete virological, immunophenotypic, and molecular characterization of retrieved tumor tissues and peripheral blood samples for purposes of identifying prognostic and predictive biomarkers of clinical outcome (i.e. treatment response, freedom from disease progression, and overall survival) in which to begin to frame pragmatic, risk-adapted therapeutic interventions suitable for the resource constrained setting in sub-Saharan Africa.
measure: Companion R01 proposal: Clinicopathological Cohort Study of EBV-Associated Lymphomas in Kenya
time frame: To be submitted next 6 months to 1 year
description: Aim 1: Determine the tissue biomarkers of EBV infection in AIDS-related lymphomas (ARL) in Kenya
Aim 2: Compare the pattern of EBV persistence in patients with EBV+ and EBV- lymphoma
Aim 3: Determine predictors of treatment outcome in AIDS-related lymphomas (ARL)
arm group label: No treatment
Tumor tissue, blood plasma and serum upon consent and suitability of sample preparation.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Scot C Remick, MD
role: Principal Investigator
affiliation: West Virginia University
last name: Walter O Mwanda, MD
role: Principal Investigator
affiliation: Kenyatta National Hospital
facility: 
facility: 
country: Kenya
country: United States
citation: Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4. Erratum In: CA Cancer J Clin. 2011 Mar-Apr;61(2):134.
PMID: 21296855
citation: World Health Organization. Cancer. Fact Sheet No. 297, February 2011. Available at http://www.who.int/mediacentre/factsheets /fs297/en/index.html. Accessioned March 28, 2011.
citation: World Health Organization. The Global Burden of Disease: 2004 Update. Geneva: WHO, 2008.
citation: Ferlay J, Shin HR, Bray F, Forman D, Mathers C, and Parkin DM. Globocan 2008: cancer incidence and mortality worldwide. Lyon: International Agency for Research on Cancer, 2010. Available at: http://www.iarc/fr/. Accessioned March 28, 2011.
citation: Remick SC. Responding to the global cancer burden through partnerships. In: Am. Soc. Clin. Oncol. Ed. Book 2009; 670-4.
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, Non-Hodgkin
mesh term: Hodgkin Disease
mesh term: Lymphoproliferative Disorders