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/NCT06000306</url>
    </required_header>
    <id_info>
      <org_study_id>IIT20230588C-R1</org_study_id>
      <nct_id>NCT06000306</nct_id>
    </id_info>
    <brief_title>MRD Monitoring by Digital Droplet PCR in the Early Period After Allo-HSCT to Predict Patients at High Risk of Relapse</brief_title>
    <official_title>Measurable Residual Disease Monitoring by Digital Droplet PCR in the Early Period After Allogeneic Hematopoietic Stem Cell Transplantation to Predict Patients at High Risk of Relapse</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zhejiang University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Zhejiang University</source>
    <oversight_info>
      <has_dmc>No</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>
        A study on the Effectiveness of digital droplet PCR in monitoring measurable residual disease&#xD;
        during the early period after allogeneic hematopoietic stem cell transplantation to predict&#xD;
        patients at high risk of relapse&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a retrospective and multicenter clinical study.This study is indicated for patients&#xD;
        with hematological malignancies who underwent allo-HSCT. It aims to evaluate the&#xD;
        effectiveness of digital droplet PCR in monitoring measurable residual disease during the&#xD;
        early period after allogeneic hematopoietic stem cell transplantation to predict patients at&#xD;
        high risk of relapse. 192 patients will be enrolled. The clinical end points include&#xD;
        cumulative incidence of relapse, relapse-free survival, non-relapse mortality, and overall&#xD;
        survival.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2018</start_date>
    <completion_date type="Actual">July 31, 2023</completion_date>
    <primary_completion_date type="Actual">August 31, 2021</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>Cumulative incidence of relapse (CIR)</measure>
      <time_frame>At Year 2</time_frame>
      <description>The time from the date of transplantation to disease recurrence:&#xD;
  Disease recurrence, defined as one of the following:&#xD;
  Leukemia blasts reappeared in peripheral blood, or blasts ≥ 5%, naive monocytes ≥ 5% in bone marrow, or extramedullary lesions.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Relapse-free survival (RFS)</measure>
      <time_frame>At Year 2</time_frame>
      <description>The time from the date of treatment to the occurrence of any of the following:&#xD;
  Death from any cause&#xD;
  Disease recurrence</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Non-relapse mortality (NRM)</measure>
      <time_frame>At Year 2</time_frame>
      <description>Assessment of NRM at Year 2</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival (OS)</measure>
      <time_frame>At Year 2</time_frame>
      <description>Assessment of OS at Year 2</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">192</enrollment>
    <condition>Measurable Residual Disease</condition>
    <arm_group>
      <arm_group_label>ddPCR MRD positivity</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>ddPCR MRD negativity</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Digital Droplet PCR</intervention_name>
      <description>Measurable residual disease Monitoring by Digital Droplet PCR in the Early Posttransplant Period</description>
      <arm_group_label>ddPCR MRD negativity</arm_group_label>
      <arm_group_label>ddPCR MRD positivity</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with hematological malignancies who underwent allo-HSCT were enrolled for MRD&#xD;
          mornitoring in the early period of allo-HSCT&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. The presence of at least one haematological tumour-associated mutation or fusion gene&#xD;
               detected at diagnosis by NGS or real-time qPCR provided for posttransplant MRD&#xD;
               monitoring;&#xD;
  &#xD;
            2. Successful stem cell engraftment&#xD;
  &#xD;
            3. Received at least one bone marrow MRD detection by ddPCR in +30 days to +120 days&#xD;
               after HSCT;&#xD;
  &#xD;
            4. Age 12-70&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients who relapsed or died before the first ddPCR monitoring;&#xD;
  &#xD;
            2. Patients with only germline mutations.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
    </eligibility>
    <location>
      <facility>
        <name>The First Hospital of Zhejiang Medical Colleage Zhejiang University</name>
        <address>
          <city>Hangzhou</city>
          <state>Zhejiang</state>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Zhejiang University</investigator_affiliation>
      <investigator_full_name>He Huang</investigator_full_name>
      <investigator_title>The President of The First Affiliated Hospital, College of Medicine, Zhejiang University</investigator_title>
    </responsible_party>
    <keyword>droplet digital PCR</keyword>
    <keyword>allogeneic hematopoietic stem cell transplantation</keyword>
    <keyword>relapse</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasm, Residual</mesh_term>
      <mesh_term>Recurrence</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/NCT06000306
  org study id: IIT20230588C-R1
  nct id: NCT06000306
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  A study on the Effectiveness of digital droplet PCR in monitoring measurable residual disease
        during the early period after allogeneic hematopoietic stem cell transplantation to predict
        patients at high risk of relapse
  This is a retrospective and multicenter clinical study.This study is indicated for patients
        with hematological malignancies who underwent allo-HSCT. It aims to evaluate the
        effectiveness of digital droplet PCR in monitoring measurable residual disease during the
        early period after allogeneic hematopoietic stem cell transplantation to predict patients at
        high risk of relapse. 192 patients will be enrolled. The clinical end points include
        cumulative incidence of relapse, relapse-free survival, non-relapse mortality, and overall
        survival.
  observational model: Cohort
  time perspective: Retrospective
  measure: Cumulative incidence of relapse (CIR)
  time frame: At Year 2
  description: The time from the date of transplantation to disease recurrence:
  Disease recurrence, defined as one of the following:
  Leukemia blasts reappeared in peripheral blood, or blasts ≥ 5%, naive monocytes ≥ 5% in bone marrow, or extramedullary lesions.
  measure: Relapse-free survival (RFS)
  time frame: At Year 2
  description: The time from the date of treatment to the occurrence of any of the following:
  Death from any cause
  Disease recurrence
  measure: Non-relapse mortality (NRM)
  time frame: At Year 2
  description: Assessment of NRM at Year 2
  measure: Overall survival (OS)
  time frame: At Year 2
  description: Assessment of OS at Year 2
  arm group label: ddPCR MRD positivity
  arm group label: ddPCR MRD negativity
  intervention type: Diagnostic Test
  intervention name: Digital Droplet PCR
  description: Measurable residual disease Monitoring by Digital Droplet PCR in the Early Posttransplant Period
  arm group label: ddPCR MRD negativity
  arm group label: ddPCR MRD positivity
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 12 Years
  maximum age: 70 Years
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Zhejiang University
  investigator full name: He Huang
  investigator title: The President of The First Affiliated Hospital, College of Medicine, Zhejiang University
  mesh term: Neoplasm, Residual
  mesh term: Recurrence