<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/NCT04428489</url>
  </required_header>
  <id_info>
    <org_study_id>SZcytopenia01</org_study_id>
    <nct_id>NCT04428489</nct_id>
  </id_info>
  <brief_title>Follow-up Study of ICUS and CCUS Patients</brief_title>
  <official_title>A Follow-up Observational Study of ICUS and CCUS Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Affiliated Hospital of Soochow University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Affiliated Hospital of Soochow 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>
      The proposed minimal diagnostic criteria for myelodysplastic syndromes (MDS) and potential&#xD;
      pre-MDS conditions has been released by an international consensus group. Based on the&#xD;
      criteria, patients with persistent cytopenia could be diagnosed with MDS, CCUS and ICUS.&#xD;
      However, the process and outcome of pre-MDS conditions (CCUS, ICUS) is still to be&#xD;
      characterized in Chinese population. We design this prospective observational study to&#xD;
      explore the disease process and outcome in ICUS and CCUS patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">January 1, 2011</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>Culumative transformation rate</measure>
    <time_frame>5 years</time_frame>
    <description>Transformation is defined as progression from ICUS to CCUS, ICUS to MDS or CCUS to MDS. All patients are followed-up since entry into this trial and transformation events are recorded. Cumulative transformation rate is defined for all patients and estimated by competing risk methods.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Event-free survival</measure>
    <time_frame>5 years</time_frame>
    <description>Defined for all patients entry into this trial; measured from the date of entry into this trial to the date of progression or death from any cause; patients not known to have any of these events are censored on the date they were last examined.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Myelodysplastic Syndromes</condition>
  <arm_group>
    <arm_group_label>Idiopathic cytopenia of undetermined significance (ICUS)</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Clonal cytopenia of unknown significance (CCUS)</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observation and necessary supportive care</intervention_name>
    <description>For patients with ICUS and CCUS, necessary supportive care could be given. No addtitional treatment is administrated.</description>
    <arm_group_label>Clonal cytopenia of unknown significance (CCUS)</arm_group_label>
    <arm_group_label>Idiopathic cytopenia of undetermined significance (ICUS)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients diagnosed with ICUS and CCUS based on the proposed minimal diagnostic criteria for&#xD;
        myelodysplastic syndromes (MDS) and potential pre-MDS conditions&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with cytopenia of any degree in one or more lineages: erythrocytes,&#xD;
             neutrophils, or platelets. And the cytopenia has to be persistent (≥ 4 months) and&#xD;
             lacking minimal diagnostic criteria of MDS.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with cytopenia which could be explained by any other hematologic or&#xD;
             non-hematologic disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The First Affliated Hospital of Soochow University</name>
      <address>
        <city>Suzhou</city>
        <state>Jiangsu</state>
        <zip>215006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>April 26, 2023</last_update_submitted>
  <last_update_submitted_qc>April 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The First Affiliated Hospital of Soochow University</investigator_affiliation>
    <investigator_full_name>Sheng-Li Xue, MD</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Idiopathic cytopenia of undetermined significance (ICUS)</keyword>
  <keyword>Clonal cytopenia of unknown significance (CCUS)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myelodysplastic Syndromes</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/NCT04428489
org study id: SZcytopenia01
nct id: NCT04428489
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The proposed minimal diagnostic criteria for myelodysplastic syndromes (MDS) and potential
      pre-MDS conditions has been released by an international consensus group. Based on the
      criteria, patients with persistent cytopenia could be diagnosed with MDS, CCUS and ICUS.
      However, the process and outcome of pre-MDS conditions (CCUS, ICUS) is still to be
      characterized in Chinese population. We design this prospective observational study to
      explore the disease process and outcome in ICUS and CCUS patients.
observational model: Cohort
time perspective: Prospective
measure: Culumative transformation rate
time frame: 5 years
description: Transformation is defined as progression from ICUS to CCUS, ICUS to MDS or CCUS to MDS. All patients are followed-up since entry into this trial and transformation events are recorded. Cumulative transformation rate is defined for all patients and estimated by competing risk methods.
measure: Event-free survival
time frame: 5 years
description: Defined for all patients entry into this trial; measured from the date of entry into this trial to the date of progression or death from any cause; patients not known to have any of these events are censored on the date they were last examined.
arm group label: Idiopathic cytopenia of undetermined significance (ICUS)
arm group label: Clonal cytopenia of unknown significance (CCUS)
intervention type: Other
intervention name: Observation and necessary supportive care
description: For patients with ICUS and CCUS, necessary supportive care could be given. No addtitional treatment is administrated.
arm group label: Clonal cytopenia of unknown significance (CCUS)
arm group label: Idiopathic cytopenia of undetermined significance (ICUS)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: The First Affiliated Hospital of Soochow University
investigator full name: Sheng-Li Xue, MD
investigator title: Associate Professor
mesh term: Myelodysplastic Syndromes
sharing ipd: Undecided