<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/NCT03798665</url>
  </required_header>
  <id_info>
    <org_study_id>CB-RWS</org_study_id>
    <nct_id>NCT03798665</nct_id>
  </id_info>
  <brief_title>A Real World Study Evaluating the Clinical Application of PEG-rhG-CSF During Chemotherapy in Patients With Solid Tumors</brief_title>
  <official_title>A Prospective, Multicenter, Non-interventional Registry Study Evaluating the Clinical Application of PEG-rhG-CSF During Chemotherapy in Patients With Malignant Solid Tumors in Sichuan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Afﬁliated Hospital of North Sichuan Medical College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Afﬁliated Hospital of North Sichuan Medical College</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>
      Prospective, multicenter, non-interventional registration studies were used in this project .&#xD;
      Eight hundreds patients with solid tumors who met the inclusion criteria in six hospitals in&#xD;
      Sichuan Province, Sichuan Province, were selected from the first chemotherapy cycle using&#xD;
      PEG-rhG-CSF (can be any chemotherapy cycle of the patient), and each subsequent chemotherapy&#xD;
      cycle was recorded. The use of PEG-rhG-CSF and related patient outcomes until the end of&#xD;
      chemotherapy. Analyze the clinical practice of using PEG-rhG-CSF in the real world.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 6, 2018</start_date>
  <completion_date type="Anticipated">July 6, 2019</completion_date>
  <primary_completion_date type="Anticipated">July 6, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Dosage of PEG-rhG-CSF in chemotherapy</measure>
    <time_frame>1 YEAR</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Administration time of PEG-rhG-CSF in chemotherapy</measure>
    <time_frame>1 YEAR</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>dosing frequency of PEG-rhG-CSF in chemotherapy</measure>
    <time_frame>1 YEAR</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">800</enrollment>
  <condition>Neutropenia</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pegfilgrastim（PEG-rhG-CSF）</intervention_name>
    <description>From the first chemotherapy cycle using PEG-rhG-CSF (which can be any chemotherapy cycle of the patient), record the use of PEG-rhG-CSF in this cycle and each subsequent chemotherapy cycle, including dosage, administration time and dosing frequency</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        1. Age ≥ 18 years old;&#xD;
&#xD;
          2. Diagnosed as a malignant solid tumor by histology and cytology, requiring chemotherapy&#xD;
             patients;&#xD;
&#xD;
          3. The first use of PEG-rhG-CSF during the chemotherapy cycle (not limited to the first&#xD;
             chemotherapy cycle, can be any chemotherapy cycle of the patient);&#xD;
&#xD;
          4. Subjects volunteered to participate in this clinical trial and signed informed&#xD;
             consent.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 18 years old;&#xD;
&#xD;
          2. Diagnosed as a malignant solid tumor by histology and cytology, requiring chemotherapy&#xD;
             patients;&#xD;
&#xD;
          3. The first use of PEG-rhG-CSF during the chemotherapy cycle (not limited to the first&#xD;
             chemotherapy cycle, can be any chemotherapy cycle of the patient);&#xD;
&#xD;
          4. Subjects volunteered to participate in this clinical trial and signed informed&#xD;
             consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. PEG-rhG-CSF was used in the current chemotherapy cycle;&#xD;
&#xD;
          2. Have received hematopoietic stem cell transplantation or bone marrow transplantation;&#xD;
&#xD;
          3. Other drug clinical trials are currently underway.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Xian Bang Tan</last_name>
    <phone>13458406996</phone>
    <email>tbx-n9mB@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Affiliated Hospital of North Sichuan Medical College</name>
      <address>
        <city>Nanchong</city>
        <state>Sichuan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xian Bang Tan</last_name>
      <phone>13458406996</phone>
      <email>tbx-n9mB@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>January 8, 2019</last_update_submitted>
  <last_update_submitted_qc>January 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Afﬁliated Hospital of North Sichuan Medical College</investigator_affiliation>
    <investigator_full_name>DaiYuan Ma</investigator_full_name>
    <investigator_title>Director of Cancer Center Affiliation: Afﬁliated Hospital of North Sichuan Medical College</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neutropenia</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/NCT03798665
org study id: CB-RWS
nct id: NCT03798665
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Prospective, multicenter, non-interventional registration studies were used in this project .
      Eight hundreds patients with solid tumors who met the inclusion criteria in six hospitals in
      Sichuan Province, Sichuan Province, were selected from the first chemotherapy cycle using
      PEG-rhG-CSF (can be any chemotherapy cycle of the patient), and each subsequent chemotherapy
      cycle was recorded. The use of PEG-rhG-CSF and related patient outcomes until the end of
      chemotherapy. Analyze the clinical practice of using PEG-rhG-CSF in the real world.
observational model: Other
time perspective: Prospective
measure: Dosage of PEG-rhG-CSF in chemotherapy
time frame: 1 YEAR
measure: Administration time of PEG-rhG-CSF in chemotherapy
time frame: 1 YEAR
measure: dosing frequency of PEG-rhG-CSF in chemotherapy
time frame: 1 YEAR
intervention type: Drug
intervention name: Pegfilgrastim（PEG-rhG-CSF）
description: From the first chemotherapy cycle using PEG-rhG-CSF (which can be any chemotherapy cycle of the patient), record the use of PEG-rhG-CSF in this cycle and each subsequent chemotherapy cycle, including dosage, administration time and dosing frequency
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Xian Bang Tan
phone: 13458406996
email: tbx-n9mB@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Afﬁliated Hospital of North Sichuan Medical College
investigator full name: DaiYuan Ma
investigator title: Director of Cancer Center Affiliation: Afﬁliated Hospital of North Sichuan Medical College
mesh term: Neutropenia