<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/NCT03297476</url>
  </required_header>
  <id_info>
    <org_study_id>ZDYYGZ201708</org_study_id>
    <nct_id>NCT03297476</nct_id>
  </id_info>
  <brief_title>Clinical Application of Novel Panels for Early Precision Diagnosis and Relapse Prediction in High-risk Leukemia</brief_title>
  <official_title>Early Precision Diagnosis and Relapse Prediction Technology Development in High-risk Acute Leukemia and Clinical Application</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhongda Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zhongda Hospital</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>
      Based on the investigator's previous data on risk classification for acute leukemia,the&#xD;
      investigators will design a set of panels to detect the gene expression and genomic variants&#xD;
      (SNPs, mutation, insertion, deletion and fusion genes, etc), and identify the high-risk&#xD;
      subtypes of acute leukemia, such as Ph-like acute lymphoblastic leukemia. Furthermore, the&#xD;
      target therapy (Tyrosine Kinase Inhibitors,et.al) will be used to treat the identified&#xD;
      patients. In addition, more sensitive minimal residual disease (MRD) detection technology&#xD;
      will be designed and used to detect the MRD in patients to early predict the disease relapse.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      patient eligibility criteria: newly diagnosed acute leukemia patients with clinical high-risk&#xD;
      markers, reflactory and relapsed patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</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>complete remission</measure>
    <time_frame>From date of randomization or initial treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months</time_frame>
    <description>Patients achieve complete remission after initial treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>relapse</measure>
    <time_frame>From date of randomization or complete remission until the date of first documented relapse from any cause, whichever came first, assessed up to 100 weeks</time_frame>
    <description>Patients' disease progress after complete remission</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Leukemia, Acute</condition>
  <arm_group>
    <arm_group_label>high-risk group</arm_group_label>
    <description>Selected by &quot;High-risk subtype detection panels&quot;</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non high-risk group</arm_group_label>
    <description>Selected by &quot;High-risk subtype detection panels&quot;</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>High-risk subtype detection panels</intervention_name>
    <description>The designed detection technology were used to identify the high-risk patients cohort.</description>
    <arm_group_label>high-risk group</arm_group_label>
    <arm_group_label>non high-risk group</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Patients' samples from bone marrow&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        patients with acute leukemia (newly diagnosis)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newly diagnostic acute lymphoblastic leukemia Be willing to start treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  chronic leukemia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Hematology, Zhongda Hospital Southeast University, Institute of Hematology Southeast University</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>March 23, 2022</last_update_submitted>
  <last_update_submitted_qc>March 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zhongda Hospital</investigator_affiliation>
    <investigator_full_name>Ge Zheng</investigator_full_name>
    <investigator_title>Director of Hematology Department</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</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/NCT03297476
org study id: ZDYYGZ201708
nct id: NCT03297476
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Based on the investigator's previous data on risk classification for acute leukemia,the
      investigators will design a set of panels to detect the gene expression and genomic variants
      (SNPs, mutation, insertion, deletion and fusion genes, etc), and identify the high-risk
      subtypes of acute leukemia, such as Ph-like acute lymphoblastic leukemia. Furthermore, the
      target therapy (Tyrosine Kinase Inhibitors,et.al) will be used to treat the identified
      patients. In addition, more sensitive minimal residual disease (MRD) detection technology
      will be designed and used to detect the MRD in patients to early predict the disease relapse.
patient eligibility criteria: newly diagnosed acute leukemia patients with clinical high-risk
      markers, reflactory and relapsed patients.
observational model: Cohort
time perspective: Prospective
measure: complete remission
time frame: From date of randomization or initial treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
description: Patients achieve complete remission after initial treatment
measure: relapse
time frame: From date of randomization or complete remission until the date of first documented relapse from any cause, whichever came first, assessed up to 100 weeks
description: Patients' disease progress after complete remission
arm group label: high-risk group
description: Selected by "High-risk subtype detection panels"
arm group label: non high-risk group
description: Selected by "High-risk subtype detection panels"
intervention type: Diagnostic Test
intervention name: High-risk subtype detection panels
description: The designed detection technology were used to identify the high-risk patients cohort.
arm group label: high-risk group
arm group label: non high-risk group
Patients' samples from bone marrow
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 14 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Zhongda Hospital
investigator full name: Ge Zheng
investigator title: Director of Hematology Department
mesh term: Leukemia