<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/NCT02975661</url>
  </required_header>
  <id_info>
    <org_study_id>HE-201601</org_study_id>
    <nct_id>NCT02975661</nct_id>
  </id_info>
  <brief_title>Registry of Huaier Granule for Prevention of Recurrence and Metastasis of Gastrointestinal Cancer After Radical Surgery</brief_title>
  <official_title>Registry of Huaier Granule for Prevention of Recurrence and Metastasis of Gastrointestinal Cancer After Radical Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Qidong Gaitianli Medicines Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Qidong Gaitianli Medicines Co., Ltd</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Registration of patients after gastrointestinal cancer radical surgery, including the&#xD;
      information of treatments, recurrence &amp; metastasis, adverse events,etc.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">October 30, 2021</completion_date>
  <primary_completion_date type="Actual">June 30, 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>Disease free survival (DFS)</measure>
    <time_frame>Up to 2 years</time_frame>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">840</enrollment>
  <condition>Gastrointestinal Cancer</condition>
  <arm_group>
    <arm_group_label>Observational 1</arm_group_label>
    <description>Huaier Granule</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Observational 2</arm_group_label>
    <description>Radiotherapy or chemotherapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Observational 3</arm_group_label>
    <description>treatment abandoned</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Observational 4</arm_group_label>
    <description>Huaier Granule &amp; Radiotherapy or chemotherapy</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients after gastrointestinal cancer radical surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with gastrointestinal cancer (stomach, colon or rectum);&#xD;
&#xD;
          2. Patients who have received gastrointestinal cancer radical surgery within a month;&#xD;
&#xD;
          3. Patients between 18 and 70 years old,no gender restriction;&#xD;
&#xD;
          4. Patients volunteer to participate this study and have signed the informed consent&#xD;
             form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. No chemotherapy or combined radiation and chemotherapy indications；&#xD;
&#xD;
          2. Unable to cooperate to complete related information collection;&#xD;
&#xD;
          3. Participation in any other clinical trial within three months;&#xD;
&#xD;
          4. Conditions that are considered not suitable for this study investigators.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>LU</name>
      <address>
        <city>Qidong</city>
        <state>Anhui</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>yonghui lu</last_name>
      <phone>13801462500</phone>
      <email>lyh307@sina.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>November 24, 2016</study_first_submitted>
  <study_first_submitted_qc>November 24, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>December 14, 2020</last_update_submitted>
  <last_update_submitted_qc>December 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastrointestinal Neoplasms</mesh_term>
    <mesh_term>Recurrence</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/NCT02975661
org study id: HE-201601
nct id: NCT02975661
lead sponsor: 
has dmc: Yes
Registration of patients after gastrointestinal cancer radical surgery, including the
      information of treatments, recurrence & metastasis, adverse events,etc.
observational model: Other
time perspective: Prospective
measure: Disease free survival (DFS)
time frame: Up to 2 years
arm group label: Observational 1
description: Huaier Granule
arm group label: Observational 2
description: Radiotherapy or chemotherapy
arm group label: Observational 3
description: treatment abandoned
arm group label: Observational 4
description: Huaier Granule & Radiotherapy or chemotherapy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Gastrointestinal Neoplasms
mesh term: Recurrence