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/NCT06012318</url>
    </required_header>
    <id_info>
      <org_study_id>SPRING</org_study_id>
      <nct_id>NCT06012318</nct_id>
    </id_info>
    <brief_title>Dynamic Follow-up of Symptoms Based on Patient-reported Outcomes in Immunotherapy for Esophageal Cancer: a Prospective Multicentre Cohort Study (SPRING)</brief_title>
    <official_title>Dynamic Follow-up of Symptoms Based on Patient-reported Outcomes in Immunotherapy for Esophageal Cancer: a Prospective Multicentre Cohort Study (SPRING)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Guangdong Provincial People's Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>First Affiliated Hospital of Shantou University Medical College</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The General Hospital of Southern Theater Command</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The First Affiliated Hospital of Guangdong Pharmaceutical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Shantou Central Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Affiliated Cancer Hospital of Shantou University Medical College</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Shenzhen Second People's Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Longgang District Central Hospital of Shenzhen</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Shenzhen Third People's Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Shenzhen People's Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Sichuan Cancer Hospital and Research Institute</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Guangzhou Panyu Central Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Guangdong Provincial People's Hospital</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>
        Immunotherapy shows satisfactory effectiveness and safety in patients with esophageal cancer.&#xD;
        Immunotherapy-based regimens have a better survival benefit compared to previous chemotherapy&#xD;
        and radiotherapy. Patient-reported outcomes (PRO) provide a reliable assessment of patients'&#xD;
        functional status during treatment. However, the spectrum of symptoms in esophageal cancer&#xD;
        patients receiving immunotherapy is uncertain, and there are no studies applying the symptom&#xD;
        bank based on PRO to the immunotherapy model for esophageal cancer. In this prospective&#xD;
        study, the investigators aimed to preliminarily screen for symptoms associated with&#xD;
        immunotherapy for esophageal cancer through a systematic literature review and expert&#xD;
        evaluation, and build a symptom item bank for esophageal cancer patients receiving&#xD;
        immunotherapy. Adverse symptoms in esophageal cancer patients treated with immunotherapy were&#xD;
        collected prospectively. The distribution and severity of the symptoms, as well as the&#xD;
        trajectory of symptom change were further analyzed to demonstrate the validity and&#xD;
        reliability of the symptom item bank. It would refine the spectrum of symptoms for esophageal&#xD;
        cancer patients receiving immunotherapy and provide a foundation for assessing the specific&#xD;
        symptom burden in patients with esophageal cancer receiving immunotherapy regimens.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 10, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2024</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>Prevalence and severity of adverse symptoms</measure>
      <time_frame>Patients were evaluated from the beginning of immunochemotherapy to three weeks after completion of the last immunochemotherapy treatment. The total time for patient evaluation is less than 6 months.</time_frame>
      <description>Incidence and severity of adverse symptoms in esophageal cancer patients treated with immunotherapy</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Trajectory of adverse symptoms</measure>
      <time_frame>Patients were evaluated from the beginning of immunochemotherapy to three weeks after completion of the last immunochemotherapy treatment. The total time for patient evaluation is less than 6 months.</time_frame>
      <description>Trajectory of adverse symptoms in esophageal cancer patients treated with immunotherapy</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">220</enrollment>
    <condition>Esophageal Cancer</condition>
    <condition>Patient-reported Outcomes</condition>
    <condition>Immunotherapy</condition>
    <arm_group>
      <arm_group_label>Monoimmunotherapy group</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Chemoimmunotherapy group</arm_group_label>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          The target population of the study is patients with esophageal cancer who have received or&#xD;
          are receiving immunotherapy-based regimens in various stages, including resectable, locally&#xD;
          advanced, and advanced stages.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Pathologically confirmed resectable, locally advanced, advanced metastatic esophageal&#xD;
               cancer&#xD;
  &#xD;
            -  Having received or undergoing an immunotherapy-based treatment regimen&#xD;
  &#xD;
            -  Age 18-75 years&#xD;
  &#xD;
            -  ECOG PS of 0-2&#xD;
  &#xD;
            -  Adequate organ function&#xD;
  &#xD;
            -  Life expectancy &gt; 6 months&#xD;
  &#xD;
            -  Participants are fully informed about the whole study and are willing to sign the&#xD;
               informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Absence of immunotherapy regimen, or recieving radiotherapy.&#xD;
  &#xD;
            -  Presence of primary tumours elsewhere, such as gastric cancer, lung cancer or cervical&#xD;
               cancer&#xD;
  &#xD;
            -  Severe organ function deterioration and intolerance to immunotherapy&#xD;
  &#xD;
            -  Pregnant or breast-feeding women&#xD;
  &#xD;
            -  Previous autoimmune disease&#xD;
  &#xD;
            -  Any other conditions that may affect patients' safety and compliance&#xD;
  &#xD;
            -  Psychological, family, social and other factors leading to inability to inform consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Guibin Qiao, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Guangdong Provincial People's Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Guibin Qiao, MD</last_name>
      <phone>13602749153</phone>
      <email>guibinqiao@126.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Guangdong Provincial People's Hospital</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510080</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Guangdong Provincial People's Hospital</investigator_affiliation>
      <investigator_full_name>GuiBin Qiao</investigator_full_name>
      <investigator_title>Professor of Medicine</investigator_title>
    </responsible_party>
    <keyword>Esophageal Cancer</keyword>
    <keyword>Immunotherapy</keyword>
    <keyword>Patient-reported Outcomes</keyword>
    <keyword>Symptom item bank</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Esophageal Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06012318
  org study id: SPRING
  nct id: NCT06012318
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Immunotherapy shows satisfactory effectiveness and safety in patients with esophageal cancer.
        Immunotherapy-based regimens have a better survival benefit compared to previous chemotherapy
        and radiotherapy. Patient-reported outcomes (PRO) provide a reliable assessment of patients'
        functional status during treatment. However, the spectrum of symptoms in esophageal cancer
        patients receiving immunotherapy is uncertain, and there are no studies applying the symptom
        bank based on PRO to the immunotherapy model for esophageal cancer. In this prospective
        study, the investigators aimed to preliminarily screen for symptoms associated with
        immunotherapy for esophageal cancer through a systematic literature review and expert
        evaluation, and build a symptom item bank for esophageal cancer patients receiving
        immunotherapy. Adverse symptoms in esophageal cancer patients treated with immunotherapy were
        collected prospectively. The distribution and severity of the symptoms, as well as the
        trajectory of symptom change were further analyzed to demonstrate the validity and
        reliability of the symptom item bank. It would refine the spectrum of symptoms for esophageal
        cancer patients receiving immunotherapy and provide a foundation for assessing the specific
        symptom burden in patients with esophageal cancer receiving immunotherapy regimens.
  observational model: Cohort
  time perspective: Prospective
  measure: Prevalence and severity of adverse symptoms
  time frame: Patients were evaluated from the beginning of immunochemotherapy to three weeks after completion of the last immunochemotherapy treatment. The total time for patient evaluation is less than 6 months.
  description: Incidence and severity of adverse symptoms in esophageal cancer patients treated with immunotherapy
  measure: Trajectory of adverse symptoms
  time frame: Patients were evaluated from the beginning of immunochemotherapy to three weeks after completion of the last immunochemotherapy treatment. The total time for patient evaluation is less than 6 months.
  description: Trajectory of adverse symptoms in esophageal cancer patients treated with immunotherapy
  arm group label: Monoimmunotherapy group
  arm group label: Chemoimmunotherapy group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Guibin Qiao, MD
  role: Principal Investigator
  affiliation: Guangdong Provincial People's Hospital
  last name: Guibin Qiao, MD
  phone: 13602749153
  email: guibinqiao@126.com
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Guangdong Provincial People's Hospital
  investigator full name: GuiBin Qiao
  investigator title: Professor of Medicine
  mesh term: Esophageal Neoplasms
  sharing ipd: No