<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/NCT01661218</url>
  </required_header>
  <id_info>
    <org_study_id>HCH20120530</org_study_id>
    <secondary_id>HCH20120530-008</secondary_id>
    <nct_id>NCT01661218</nct_id>
  </id_info>
  <brief_title>Complications and Risk Factors Related With Central Venous Catheters in Cancer Patients</brief_title>
  <acronym>CVCCP</acronym>
  <official_title>Complications and Risk Factors Related With Central Venous Catheters in Cancer Patients(CVCCP)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Huanxing Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Huanxing Cancer Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators aim to determine the complications and risk factors related with&#xD;
      peripherally inserted central catheters (PICCs) and central venous catheters (CVCs) in cancer&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to determine the complications and risk factors related with&#xD;
      peripherally inserted central catheters (PICCs) and central venous catheters (CVCs) in cancer&#xD;
      patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">August 2019</completion_date>
  <primary_completion_date type="Actual">August 2019</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>Catheter-related venous thrombosis and catheter-related infections</measure>
    <time_frame>30 days after PICC and CVC line withdrawn</time_frame>
    <description>Catheter-related venous thrombosis and catheter-related infections</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Catheter tip position</measure>
    <time_frame>participants will be followed before PICC and CVC line withdrawn</time_frame>
    <description>Catheter tip position</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">3500</enrollment>
  <condition>Thrombosis</condition>
  <condition>Infections</condition>
  <arm_group>
    <arm_group_label>complications</arm_group_label>
    <description>catheter-related venous thrombosis catheter-related infections</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All adult cancer patients with CVC and PICC placed at BeijingHCH and with written consent&#xD;
        for this study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all adult cancer patients with central venous catheters (CVCs) or peripherally&#xD;
             inserted central catheters (PICCs) placed at BeijingHCH.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  without written informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jian DING, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Beijing Huanxing Cancer Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beijing Huanxing Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 2, 2012</study_first_submitted>
  <study_first_submitted_qc>August 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 9, 2012</study_first_posted>
  <last_update_submitted>September 2, 2020</last_update_submitted>
  <last_update_submitted_qc>September 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>catheters</keyword>
  <keyword>Central Venous</keyword>
  <keyword>complications</keyword>
  <keyword>cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombosis</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/NCT01661218
org study id: HCH20120530
secondary id: HCH20120530-008
nct id: NCT01661218
lead sponsor: 
has dmc: Yes
The investigators aim to determine the complications and risk factors related with
      peripherally inserted central catheters (PICCs) and central venous catheters (CVCs) in cancer
      patients.
The purpose of this study is to determine the complications and risk factors related with
      peripherally inserted central catheters (PICCs) and central venous catheters (CVCs) in cancer
      patients.
observational model: Cohort
time perspective: Prospective
measure: Catheter-related venous thrombosis and catheter-related infections
time frame: 30 days after PICC and CVC line withdrawn
description: Catheter-related venous thrombosis and catheter-related infections
measure: Catheter tip position
time frame: participants will be followed before PICC and CVC line withdrawn
description: Catheter tip position
arm group label: complications
description: catheter-related venous thrombosis catheter-related infections
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jian DING, MD
role: Study Chair
affiliation: Beijing Huanxing Cancer Hospital
facility: 
country: China
responsible party type: Sponsor
mesh term: Thrombosis