xml: <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/NCT06042660</url>
    </required_header>
    <id_info>
      <org_study_id>PALG CML Comorbidity</org_study_id>
      <nct_id>NCT06042660</nct_id>
    </id_info>
    <brief_title>Comorbidity Burden and Use of Concomitant Medications at CML Diagnosis</brief_title>
    <official_title>Comorbidity Burden and Use of Concomitant Medications at CML Diagnosis: A Retrospective Analysis of 527 Patients From the Polish Adult Leukemia Group Registry</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Polish Adult Leukemia Group</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Polish Adult Leukemia Group</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of the retrospective study was to further characterize the prevalence of comorbid&#xD;
        conditions as well as the use of concomitant medications in newly diagnosed CML patients in a&#xD;
        real-world setting. Hematologists from ten Polish hematological tertiary care centers were&#xD;
        asked to analyze medical records for all consecutive CML patients diagnosed with chronic&#xD;
        phase CML between January 1st 2005 and December 31st 2014.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        All three TKIs used as first line treatment of CML, (imatinib, dasatinib and nilotinib), may&#xD;
        be associated with the so called &quot;off-target&quot; effects causing specific adverse events (AEs).&#xD;
  &#xD;
        Interestingly, some co-morbidities may predispose towards developing these specific TKIs'&#xD;
        &quot;offtarget&quot; AEs.&#xD;
  &#xD;
        The aim of the retrospective study was to further characterize the prevalence of comorbid&#xD;
        conditions as well as the use of concomitant medications in newly diagnosed CML patients in a&#xD;
        real-world setting. Hematologists from ten Polish hematological tertiary care centers were&#xD;
        asked to analyze medical records for all consecutive CML patients diagnosed with chronic&#xD;
        phase CML between January 1st 2005 and December 31st 2014. Data were collected through&#xD;
        on-line case report form of the Polish Adult Leukemia Group (PALG) Registry. Baseline&#xD;
        patients' characteristics including sex, age, body mass index (BMI), risk group according to&#xD;
        Sokal score, as well as comorbidities and concomitant therapies, were recorded at the time of&#xD;
        CML diagnosis. The study was conducted in accordance with the provisions of the Declaration&#xD;
        of Helsinki.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 2016</start_date>
    <completion_date type="Actual">August 2016</completion_date>
    <primary_completion_date type="Actual">July 2016</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>the prevalence of comorbid conditions in newly diagnosed CML patients</measure>
      <time_frame>February - July 2016</time_frame>
      <description>data collected through an on-line questionnaire, descriptive data</description>
    </primary_outcome>
    <primary_outcome>
      <measure>the number of concomitant medications in newly diagnosed CML patients</measure>
      <time_frame>February - July 2016</time_frame>
      <description>data collected through an on-line questionnaire, descriptive data</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">527</enrollment>
    <condition>Chronic Myeloid Leukemia</condition>
    <arm_group>
      <arm_group_label>newly diagnosed CML patients</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>the prevalence of comorbid conditions</intervention_name>
      <description>analysis of history of comorbidities at the time of CML diagnosis</description>
      <arm_group_label>newly diagnosed CML patients</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adult patients with diagnosis of chronic phase CML diagnosed between January 1st and&#xD;
          December 31st 2014, treated with TKI (imatinib, dasatinib, nilotynib)&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1) age ≥ 18 years; 2) diagnosis of chronic phase CML between January 1st 2005 and&#xD;
               December 31st 2014.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  primary diagnosis of CML in accelerated or blastic phase&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <link>
      <url>https://pubmed.ncbi.nlm.nih.gov/29778693/</url>
      <description>Related Info</description>
    </link>
    <results_reference>
      <citation>Gora-Tybor J, Sacha T, Waclaw J, Niesiobedzka-Krezel J, Grzybowska-Izydorczyk O, Medras E, Deren-Wagemann I, Patkowska E, Seferynska I, Lewandowski K, Wache A, Blajer-Olszewska B, Watek M, Kotwica-Mojzych K, Wasilewska E, Warzocha K, Jamroziak K. Comorbidity Burden and Use of Concomitant Medications at CML Diagnosis: A Retrospective Analysis of 527 Patients From the Polish Adult Leukemia Group Registry. Clin Lymphoma Myeloma Leuk. 2018 Jul;18(7):e283-e285. doi: 10.1016/j.clml.2018.05.001. Epub 2018 May 9. No abstract available. Erratum In: Clin Lymphoma Myeloma Leuk. 2018 Oct;18(10):692.</citation>
      <PMID>29778693</PMID>
    </results_reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 11, 2023</study_first_submitted>
    <study_first_submitted_qc>September 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 16, 2023</last_update_submitted>
    <last_update_submitted_qc>September 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Polish Adult Leukemia Group</investigator_affiliation>
      <investigator_full_name>Anna Krec</investigator_full_name>
      <investigator_title>Project Manager of Polish Adult Leukemia Group</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Leukemia</mesh_term>
      <mesh_term>Leukemia, Myelogenous, Chronic, BCR-ABL Positive</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06042660
  org study id: PALG CML Comorbidity
  nct id: NCT06042660
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the retrospective study was to further characterize the prevalence of comorbid
        conditions as well as the use of concomitant medications in newly diagnosed CML patients in a
        real-world setting. Hematologists from ten Polish hematological tertiary care centers were
        asked to analyze medical records for all consecutive CML patients diagnosed with chronic
        phase CML between January 1st 2005 and December 31st 2014.
  All three TKIs used as first line treatment of CML, (imatinib, dasatinib and nilotinib), may
        be associated with the so called "off-target" effects causing specific adverse events (AEs).
  
        Interestingly, some co-morbidities may predispose towards developing these specific TKIs'
        "offtarget" AEs.
  
        The aim of the retrospective study was to further characterize the prevalence of comorbid
        conditions as well as the use of concomitant medications in newly diagnosed CML patients in a
        real-world setting. Hematologists from ten Polish hematological tertiary care centers were
        asked to analyze medical records for all consecutive CML patients diagnosed with chronic
        phase CML between January 1st 2005 and December 31st 2014. Data were collected through
        on-line case report form of the Polish Adult Leukemia Group (PALG) Registry. Baseline
        patients' characteristics including sex, age, body mass index (BMI), risk group according to
        Sokal score, as well as comorbidities and concomitant therapies, were recorded at the time of
        CML diagnosis. The study was conducted in accordance with the provisions of the Declaration
        of Helsinki.
  observational model: Cohort
  time perspective: Retrospective
  measure: the prevalence of comorbid conditions in newly diagnosed CML patients
  time frame: February - July 2016
  description: data collected through an on-line questionnaire, descriptive data
  measure: the number of concomitant medications in newly diagnosed CML patients
  time frame: February - July 2016
  description: data collected through an on-line questionnaire, descriptive data
  arm group label: newly diagnosed CML patients
  intervention type: Other
  intervention name: the prevalence of comorbid conditions
  description: analysis of history of comorbidities at the time of CML diagnosis
  arm group label: newly diagnosed CML patients
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  url: https://pubmed.ncbi.nlm.nih.gov/29778693/
  description: Related Info
  citation: Gora-Tybor J, Sacha T, Waclaw J, Niesiobedzka-Krezel J, Grzybowska-Izydorczyk O, Medras E, Deren-Wagemann I, Patkowska E, Seferynska I, Lewandowski K, Wache A, Blajer-Olszewska B, Watek M, Kotwica-Mojzych K, Wasilewska E, Warzocha K, Jamroziak K. Comorbidity Burden and Use of Concomitant Medications at CML Diagnosis: A Retrospective Analysis of 527 Patients From the Polish Adult Leukemia Group Registry. Clin Lymphoma Myeloma Leuk. 2018 Jul;18(7):e283-e285. doi: 10.1016/j.clml.2018.05.001. Epub 2018 May 9. No abstract available. Erratum In: Clin Lymphoma Myeloma Leuk. 2018 Oct;18(10):692.
  PMID: 29778693
  responsible party type: Principal Investigator
  investigator affiliation: Polish Adult Leukemia Group
  investigator full name: Anna Krec
  investigator title: Project Manager of Polish Adult Leukemia Group
  mesh term: Leukemia
  mesh term: Leukemia, Myelogenous, Chronic, BCR-ABL Positive