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/NCT06006260</url>
    </required_header>
    <id_info>
      <org_study_id>20220197B0</org_study_id>
      <nct_id>NCT06006260</nct_id>
    </id_info>
    <brief_title>Changes of Low Anterior Resection Syndrome and Balance Ability in Patients With Rectal Cancer.</brief_title>
    <official_title>Changes of Low Anterior Resection Syndrome, Balance Ability, and Quality of Life in Patients With Newly Diagnosed Rectal Cancer.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chang Gung Memorial Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Chang Gung Memorial Hospital</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 purposes of this study are to explore the trajectory of symptom distress and balance&#xD;
        ability in patients with rectal cancer.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2024</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>Prospective</time_perspective>
    </study_design_info>
    <target_duration>2 Months</target_duration>
    <primary_outcome>
      <measure>Low Anterior Resection Syndrome</measure>
      <time_frame>Change from baseline symptom at 2 months</time_frame>
      <description>Total score 0-42</description>
    </primary_outcome>
    <enrollment type="Anticipated">110</enrollment>
    <condition>Rectal Cancer</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Rectal cancer patients during therapy.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Newly diagnosed rectal cancer&#xD;
  &#xD;
            2. Patients already know their condition.&#xD;
  &#xD;
            3. Aged 20 years and older.&#xD;
  &#xD;
            4. Consciously communicate in Mandarin or Taiwanese.&#xD;
  &#xD;
            5. Agreed with the interview and had signed the permit.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Recurrent rectal cancer.&#xD;
  &#xD;
            2. KPS of patients less than 80&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Yun-Jen Chou, PhD</last_name>
      <phone>+886-3-2118800</phone>
      <phone_ext>3512</phone_ext>
      <email>yjchou@mail.cgu.edu.tw</email>
    </overall_contact>
    <location>
      <facility>
        <name>Chung Gung University</name>
        <address>
          <city>Taoyuan City</city>
          <state>Kwei-Shan Dist.</state>
          <zip>333</zip>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yun-Jen Chou, PhD</last_name>
        <phone>+886-3-2118800</phone>
        <phone_ext>3512</phone_ext>
        <email>yjchou@mail.cgu.edu.tw</email>
      </contact>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>January 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 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 28, 2023</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>Rectal Neoplasms</mesh_term>
      <mesh_term>Low Anterior Resection Syndrome</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/NCT06006260
  org study id: 20220197B0
  nct id: NCT06006260
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purposes of this study are to explore the trajectory of symptom distress and balance
        ability in patients with rectal cancer.
  observational model: Cohort
  time perspective: Prospective
  measure: Low Anterior Resection Syndrome
  time frame: Change from baseline symptom at 2 months
  description: Total score 0-42
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: N/A
  last name: Yun-Jen Chou, PhD
  phone: +886-3-2118800
  phone ext: 3512
  email: yjchou@mail.cgu.edu.tw
  facility: 
  status: Recruiting
  contact: 
  country: Taiwan
  responsible party type: Sponsor
  mesh term: Rectal Neoplasms
  mesh term: Low Anterior Resection Syndrome