xml: <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/NCT05980403</url>
    </required_header>
    <id_info>
      <org_study_id>WDRY2023-K115</org_study_id>
      <nct_id>NCT05980403</nct_id>
    </id_info>
    <brief_title>Prediction of Lymph Node Status in Stage T1 Esophageal Squamous Cell Carcinoma（RENMIN-237）</brief_title>
    <official_title>Prediction of Lymph Node Status in Stage T1 Esophageal Squamous Cell Carcinoma（RENMIN-237）</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Yongshun Chen</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Renmin Hospital of Wuhan University</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Accurate assessment of lymph node status in superficial esophageal squamous cell carcinoma is&#xD;
        of great significance for preventing undertreatment and overtreatment. However, the accuracy&#xD;
        of the commonly used preoperative imaging methods for evaluating lymph node status is not&#xD;
        high, and it is urgent to develop a prediction model that can predict the risk of individual&#xD;
        lymph node metastasis to assist in clinical decision-making. In this context, investigators&#xD;
        intend to retrospectively collect the clinical and pathological data of 300 patients with&#xD;
        superficial esophageal squamous cell carcinoma, construct a lymph node metastasis risk&#xD;
        prediction model. In addition, investigators are also preparing to prospectively collect&#xD;
        tissue samples from 30 patients with superficial esophageal squamous cell carcinoma to&#xD;
        further explore the mechanism of lymph node metastasis.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 18, 2023</start_date>
    <completion_date type="Anticipated">January 18, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 18, 2023</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <target_duration>2 Years</target_duration>
    <primary_outcome>
      <measure>Lymphatic metastases</measure>
      <time_frame>Through study completion, an average of 2 year</time_frame>
      <description>The primary end point was the presence of lymph node metastases in surgically resected specimens (≥ 15 resected lymph nodes), or the development of metastases during follow-up including local recurrence and distant metastasis (AJCC 8th). In cases of an endoscopic resection prior to surgical resection, the tumor was found in the endoscopic resection specimen and lymph node status in the surgical resection specimen. When no additional surgery was performed after endoscopic resection, the development of metastases during follow-up was used as a surrogate end point.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Esophageal Squamous Cell Carcinoma</condition>
    <arm_group>
      <arm_group_label>Lymph node metastasis negative</arm_group_label>
      <description>Superficial esophageal squamous cell carcinoma with negative lymph node metastasis</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Lymph node metastasis positive</arm_group_label>
      <description>Superficial esophageal squamous cell carcinoma with positive lymph node metastasis</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>no intervention</intervention_name>
      <description>no intervention</description>
      <arm_group_label>Lymph node metastasis positive</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        tumor tissue samples&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with superficial esophageal squamous cell carcinoma who underwent endoscopic&#xD;
          therapy or esophagectomy.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients diagnosed with esophageal cancer in Renmin Hospital of Wuhan University from&#xD;
               2013 to 2022.&#xD;
  &#xD;
            2. Histopathological diagnosis was squamous cell carcinoma.&#xD;
  &#xD;
            3. T1NxM0.&#xD;
  &#xD;
            4. Received endoscopic resection or esophagectomy.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients who received neoadjuvant therapy.&#xD;
  &#xD;
            2. Positive surgical margin.&#xD;
  &#xD;
            3. Prior malignancy requiring active treatment within the previous 3 years except for&#xD;
               locally curable cancers that have been apparently cured.&#xD;
  &#xD;
            4. Lack of complete histopathological information.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Yongshun Chen, MD</last_name>
      <phone>+8615327122084</phone>
      <email>yongshun2007@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Renmin hosptial of Wuhan University</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <zip>430060</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Liwei Chen</last_name>
        <phone>86+15671578311</phone>
        <email>wdrmiit@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>July 29, 2023</last_update_submitted>
    <last_update_submitted_qc>July 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Renmin Hospital of Wuhan University</investigator_affiliation>
      <investigator_full_name>Yongshun Chen</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>superficial esophageal squamous cell carcinoma</keyword>
    <keyword>lymph node metastasis</keyword>
    <keyword>prediction model</keyword>
    <keyword>tumor- infiltrating immune cells</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carcinoma</mesh_term>
      <mesh_term>Carcinoma, Squamous Cell</mesh_term>
      <mesh_term>Esophageal Squamous Cell Carcinoma</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05980403
  org study id: WDRY2023-K115
  nct id: NCT05980403
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Accurate assessment of lymph node status in superficial esophageal squamous cell carcinoma is
        of great significance for preventing undertreatment and overtreatment. However, the accuracy
        of the commonly used preoperative imaging methods for evaluating lymph node status is not
        high, and it is urgent to develop a prediction model that can predict the risk of individual
        lymph node metastasis to assist in clinical decision-making. In this context, investigators
        intend to retrospectively collect the clinical and pathological data of 300 patients with
        superficial esophageal squamous cell carcinoma, construct a lymph node metastasis risk
        prediction model. In addition, investigators are also preparing to prospectively collect
        tissue samples from 30 patients with superficial esophageal squamous cell carcinoma to
        further explore the mechanism of lymph node metastasis.
  observational model: Cohort
  time perspective: Other
  measure: Lymphatic metastases
  time frame: Through study completion, an average of 2 year
  description: The primary end point was the presence of lymph node metastases in surgically resected specimens (≥ 15 resected lymph nodes), or the development of metastases during follow-up including local recurrence and distant metastasis (AJCC 8th). In cases of an endoscopic resection prior to surgical resection, the tumor was found in the endoscopic resection specimen and lymph node status in the surgical resection specimen. When no additional surgery was performed after endoscopic resection, the development of metastases during follow-up was used as a surrogate end point.
  arm group label: Lymph node metastasis negative
  description: Superficial esophageal squamous cell carcinoma with negative lymph node metastasis
  arm group label: Lymph node metastasis positive
  description: Superficial esophageal squamous cell carcinoma with positive lymph node metastasis
  intervention type: Other
  intervention name: no intervention
  description: no intervention
  arm group label: Lymph node metastasis positive
  tumor tissue samples
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Yongshun Chen, MD
  phone: +8615327122084
  email: yongshun2007@163.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: Renmin Hospital of Wuhan University
  investigator full name: Yongshun Chen
  investigator title: Professor
  mesh term: Carcinoma
  mesh term: Carcinoma, Squamous Cell
  mesh term: Esophageal Squamous Cell Carcinoma