<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/NCT03831828</url>
  </required_header>
  <id_info>
    <org_study_id>HebeiMUFH-ESCC</org_study_id>
    <nct_id>NCT03831828</nct_id>
  </id_info>
  <brief_title>Correlation of Gene Status and Clinical Outcomes in ESCC</brief_title>
  <acronym>ESCC</acronym>
  <official_title>Retrospective Study of Gene Status and Clinical Outcome of Esophageal Squamous Cell Carcinoma(ESCC).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>LiuJunFeng</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>OrigiMed</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Hebei Medical University Fourth Hospital</source>
  <brief_summary>
    <textblock>
      The incidence of esophageal squamous cell carcinoma is highly regional and familial. The&#xD;
      current treatment plan is based on the stage and location of the tumor.By studying the&#xD;
      relationship between the status of different genes and prognosis, it can help doctors to&#xD;
      develop precise and individualized treatment plans.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 26, 2018</start_date>
  <completion_date type="Anticipated">April 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">April 1, 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Gene test</measure>
    <time_frame>2019-2 to 2019-4</time_frame>
    <description>466 Tumor-associated gene test by next-generation sequencing(NGS)</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">46</enrollment>
  <condition>Prognosis of Patients With ESCC</condition>
  <arm_group>
    <arm_group_label>Lymph node metastasis Positive</arm_group_label>
    <description>good prognosis; without Lymph node metastasis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lymph node metastasis Negative</arm_group_label>
    <description>poor prognosis; with Lymph node metastasis.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Taihang Mountain area population in northern China.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Esophageal cancer patients who underwent surgery treatment, and postoperative&#xD;
             pathological diagnosis was squamous cell carcinoma. Patients with ESCC have complete&#xD;
             clinical information.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who also suffering from other tumors.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Junfeng Liu, MD</last_name>
    <phone>13931152296</phone>
    <email>13931152296@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Junfeng Liu</name>
      <address>
        <city>Shijiazhuang</city>
        <state>Hebei</state>
        <zip>050000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Junfeng Liu, Professor</last_name>
      <phone>13931152296</phone>
      <email>13931152296@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>February 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>February 6, 2019</last_update_submitted>
  <last_update_submitted_qc>February 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Hebei Medical University Fourth Hospital</investigator_affiliation>
    <investigator_full_name>LiuJunFeng</investigator_full_name>
    <investigator_title>Director of thoracic surgery</investigator_title>
  </responsible_party>
  <!-- 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/NCT03831828
org study id: HebeiMUFH-ESCC
nct id: NCT03831828
lead sponsor: 
collaborator: 
The incidence of esophageal squamous cell carcinoma is highly regional and familial. The
      current treatment plan is based on the stage and location of the tumor.By studying the
      relationship between the status of different genes and prognosis, it can help doctors to
      develop precise and individualized treatment plans.
observational model: Cohort
time perspective: Retrospective
measure: Gene test
time frame: 2019-2 to 2019-4
description: 466 Tumor-associated gene test by next-generation sequencing(NGS)
arm group label: Lymph node metastasis Positive
description: good prognosis; without Lymph node metastasis.
arm group label: Lymph node metastasis Negative
description: poor prognosis; with Lymph node metastasis.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 30 Years
maximum age: 80 Years
healthy volunteers: No
last name: Junfeng Liu, MD
phone: 13931152296
email: 13931152296@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Hebei Medical University Fourth Hospital
investigator full name: LiuJunFeng
investigator title: Director of thoracic surgery