<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/NCT03802409</url>
  </required_header>
  <id_info>
    <org_study_id>AHAT-105</org_study_id>
    <nct_id>NCT03802409</nct_id>
  </id_info>
  <brief_title>The Real Word Study of Albumin-binding Taxol for Lung Cancer Treatment</brief_title>
  <official_title>The Real Word Study of Albumin-binding Taxol for Lung Cancer Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Affiliated Hospital of Anhui Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Affiliated Hospital of Anhui Medical 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 investigators conduct the real world study to explore the efficacy and safety of&#xD;
      Albumin-binding taxol in lung cancer .&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 20, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">January 1, 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>Progress free survival</measure>
    <time_frame>1 year</time_frame>
    <description>Progress free survival is defined as the length of time from random assignment to disease progression or to death resulting from any cause other than the progress.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>3 year</time_frame>
    <description>overall survival is defined as the length of time from random assignment to death or to last contact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>disease control rate</measure>
    <time_frame>1 year</time_frame>
    <description>Investigators will assess treatment response according to Response Evaluation Criteria in Solid Tumors 1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective tumor response rate</measure>
    <time_frame>1 year</time_frame>
    <description>Objective tumor response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as best overall response according to radiological assessments</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Quality of life score</measure>
    <time_frame>1 year</time_frame>
    <description>Quality of life score is a questionnaire developed to assess the quality of life of cancer patients.</description>
  </other_outcome>
  <other_outcome>
    <measure>adverse events</measure>
    <time_frame>1 year</time_frame>
    <description>adverse events are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.</description>
  </other_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Lung Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Confirmed by Histopathology or Cytology of Lung cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female patients .&#xD;
&#xD;
          2. Confirmed by Histopathology or Cytology of Lung Cancer&#xD;
&#xD;
          3. Patients should be voluntary to the trial and provide with signed informed consent&#xD;
&#xD;
          4. The researchers believe patients can benefit from the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with a known history of allergic reactions and/or hypersensitivity attributed&#xD;
             to Albumin-binding taxol or its accessories&#xD;
&#xD;
          2. Pregnant or lactating women&#xD;
&#xD;
          3. Patients with Albumin-binding taxol contraindications&#xD;
&#xD;
          4. Patients of doctors considered unsuitable for the trial&#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>First Affiliated Hospital of Anhui Medical University</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <zip>230000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>January 18, 2019</last_update_submitted>
  <last_update_submitted_qc>January 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Albumin-binding taxol</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Within six months after the trial complete.</ipd_time_frame>
    <ipd_access_criteria>The data will be disclosed within six months after completion of the study.</ipd_access_criteria>
  </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/NCT03802409
org study id: AHAT-105
nct id: NCT03802409
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators conduct the real world study to explore the efficacy and safety of
      Albumin-binding taxol in lung cancer .
observational model: Cohort
time perspective: Prospective
measure: Progress free survival
time frame: 1 year
description: Progress free survival is defined as the length of time from random assignment to disease progression or to death resulting from any cause other than the progress.
measure: Overall Survival
time frame: 3 year
description: overall survival is defined as the length of time from random assignment to death or to last contact.
measure: disease control rate
time frame: 1 year
description: Investigators will assess treatment response according to Response Evaluation Criteria in Solid Tumors 1.1
measure: Objective tumor response rate
time frame: 1 year
description: Objective tumor response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as best overall response according to radiological assessments
measure: Quality of life score
time frame: 1 year
description: Quality of life score is a questionnaire developed to assess the quality of life of cancer patients.
measure: adverse events
time frame: 1 year
description: adverse events are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.
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: Sponsor
mesh term: Lung Neoplasms
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Within six months after the trial complete.
ipd access criteria: The data will be disclosed within six months after completion of the study.