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/NCT06031155</url>
    </required_header>
    <id_info>
      <org_study_id>SECC</org_study_id>
      <nct_id>NCT06031155</nct_id>
    </id_info>
    <brief_title>Swedish Esophageal and Cardia Cancer Study</brief_title>
    <acronym>SECC</acronym>
    <official_title>Swedish Esophageal and Cardia Cancer Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Karolinska Institutet</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Karolinska Institutet</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The overall objective of this nationwide Swedish project is to identify strategies that can&#xD;
        help reduce the suffering and improve the survivorship among patients surgically treated for&#xD;
        oesophageal cancer. This objective can be accomplished by a broad research approach that aims&#xD;
        to:&#xD;
  &#xD;
          1. describe health-related quality of life (HRQL)&#xD;
  &#xD;
          2. identify risk factors and preventive actions for poor HRQL&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a Swedish nationwide, prospective, and population-based cohort including 90% of all&#xD;
        patients operated on for esophageal or gastroesophageal junctional cancer in Sweden between&#xD;
        1st April 2001 and 31st December 2005. Detailed clinical data were continuously collected&#xD;
        from medical records based on a predefined study protocol to ensure uniformity. The clinical&#xD;
        data collected included patient and tumor characteristics, treatment details, and follow-up&#xD;
        on complications. Patients were followed up with health-related quality of life (HRQL)&#xD;
        questionnaires. The core questionnaire (EORTC QLQ-C30) was used to measure aspects of HRQL&#xD;
        and symptoms that are applicable for cancer patient in general, whereas the esophageal&#xD;
        cancer-specific module (EORTC QLQ-OES18) measured symptoms common among esophageal cancer&#xD;
        patients. HRQL was assessed 6 months, 3, 5, 10 and 15 years after surgery while the 20-year&#xD;
        follow-up is ongoing. All questionnaires were self-administered, delivered by mail and up to&#xD;
        three reminders were sent if required. Collection of HRQL data was obtained anonymously&#xD;
        (patients sent their answers to a central administration and not to the treating department).&#xD;
        The all-cause and disease-specific mortality was assessed by linkage to the Causes of Death&#xD;
        Registry. Informed consent was obtained from each participant.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">April 2001</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">December 2025</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>General health-related quality of life (HRQL)</measure>
      <time_frame>6 months, 3, 5, 10,15 and 20 years</time_frame>
      <description>The questionnaire used to measure general HRQL was the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). This 30-item cancer-specific questionnaire includes one global quality of life scale, five functional scales (physical, role, emotional, cognitive, and social function), three symptom scales (fatigue, nausea, and pain), and six single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The questionnaire scores were transformed into 0-100 scales. Higher scores in the global quality of life scale, functional scales, and HRQL summary score represent better HRQL or function, while higher scores in the symptom scales or items correspond to more symptoms. Missing data were handled according to the EORTC scoring manual.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Disease specific health-related quality of life (HRQL)</measure>
      <time_frame>6 months, 3, 5, 10,15 and 20 years</time_frame>
      <description>The questionnaire used to measure general HRQL was the European Organisation for Research and Treatment of Cancer Quality of Life Oesophageal Cancer Module 18 questionnaire (EORTC QLQ-OES18). This is an 18-item well-validated questionnaire measuring esophageal cancer-specific symptoms. It comprises four multi-item scales (dysphagia, eating difficulties, reflux, and pain) and six single items (trouble swallowing saliva, choking when swallowing, dry mouth, trouble with taste, trouble with coughing, and trouble talking). The response alternatives make up a four-point Likert scale: [1] 'Not at all', [2] 'A little', [3] 'Quite a bit' and [4] 'Very much'. The responses were transformed into a score within the range of 0-100. High scores in scales and single items represent high level of symptoms. Missing data were handled according to the EORTC scoring manual.</description>
    </primary_outcome>
    <enrollment type="Actual">616</enrollment>
    <condition>Oesophageal Cancer</condition>
    <condition>Surgery</condition>
    <condition>Survivorship</condition>
    <condition>Quality of Life</condition>
    <eligibility>
      <study_pop>
        <textblock>
          This study included patients having been curatively treated, including surgical resection&#xD;
          (esophagectomy), for esophageal or gastroesophageal junctional cancer (adenocarcinoma or&#xD;
          squamous cell carcinoma) between April 2, 2001 and December 31, 2005.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients who are alive and able to participate in the project 6 months following&#xD;
               surgery for oesophageal cancer are eligible to participate in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with cognitive impairment, who are unable to complete the measures in Swedish&#xD;
               or are too unwell to complete the assessment, are excluded from the study.&#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_official>
      <last_name>Pernilla Lagergren, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Karolinska Institutet</affiliation>
    </overall_official>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>September 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 3, 2023</last_update_submitted>
    <last_update_submitted_qc>September 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
      <investigator_full_name>Jesper Lagergren</investigator_full_name>
      <investigator_title>Professor of Surgery</investigator_title>
    </responsible_party>
    <!-- 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/NCT06031155
  org study id: SECC
  nct id: NCT06031155
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The overall objective of this nationwide Swedish project is to identify strategies that can
        help reduce the suffering and improve the survivorship among patients surgically treated for
        oesophageal cancer. This objective can be accomplished by a broad research approach that aims
        to:
  
          1. describe health-related quality of life (HRQL)
  
          2. identify risk factors and preventive actions for poor HRQL
  This is a Swedish nationwide, prospective, and population-based cohort including 90% of all
        patients operated on for esophageal or gastroesophageal junctional cancer in Sweden between
        1st April 2001 and 31st December 2005. Detailed clinical data were continuously collected
        from medical records based on a predefined study protocol to ensure uniformity. The clinical
        data collected included patient and tumor characteristics, treatment details, and follow-up
        on complications. Patients were followed up with health-related quality of life (HRQL)
        questionnaires. The core questionnaire (EORTC QLQ-C30) was used to measure aspects of HRQL
        and symptoms that are applicable for cancer patient in general, whereas the esophageal
        cancer-specific module (EORTC QLQ-OES18) measured symptoms common among esophageal cancer
        patients. HRQL was assessed 6 months, 3, 5, 10 and 15 years after surgery while the 20-year
        follow-up is ongoing. All questionnaires were self-administered, delivered by mail and up to
        three reminders were sent if required. Collection of HRQL data was obtained anonymously
        (patients sent their answers to a central administration and not to the treating department).
        The all-cause and disease-specific mortality was assessed by linkage to the Causes of Death
        Registry. Informed consent was obtained from each participant.
  observational model: Cohort
  time perspective: Prospective
  measure: General health-related quality of life (HRQL)
  time frame: 6 months, 3, 5, 10,15 and 20 years
  description: The questionnaire used to measure general HRQL was the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). This 30-item cancer-specific questionnaire includes one global quality of life scale, five functional scales (physical, role, emotional, cognitive, and social function), three symptom scales (fatigue, nausea, and pain), and six single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The questionnaire scores were transformed into 0-100 scales. Higher scores in the global quality of life scale, functional scales, and HRQL summary score represent better HRQL or function, while higher scores in the symptom scales or items correspond to more symptoms. Missing data were handled according to the EORTC scoring manual.
  measure: Disease specific health-related quality of life (HRQL)
  time frame: 6 months, 3, 5, 10,15 and 20 years
  description: The questionnaire used to measure general HRQL was the European Organisation for Research and Treatment of Cancer Quality of Life Oesophageal Cancer Module 18 questionnaire (EORTC QLQ-OES18). This is an 18-item well-validated questionnaire measuring esophageal cancer-specific symptoms. It comprises four multi-item scales (dysphagia, eating difficulties, reflux, and pain) and six single items (trouble swallowing saliva, choking when swallowing, dry mouth, trouble with taste, trouble with coughing, and trouble talking). The response alternatives make up a four-point Likert scale: [1] 'Not at all', [2] 'A little', [3] 'Quite a bit' and [4] 'Very much'. The responses were transformed into a score within the range of 0-100. High scores in scales and single items represent high level of symptoms. Missing data were handled according to the EORTC scoring manual.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Pernilla Lagergren, PhD
  role: Principal Investigator
  affiliation: Karolinska Institutet
  responsible party type: Principal Investigator
  investigator affiliation: Karolinska Institutet
  investigator full name: Jesper Lagergren
  investigator title: Professor of Surgery