<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/NCT03776435</url>
  </required_header>
  <id_info>
    <org_study_id>AppyCTcancer</org_study_id>
    <nct_id>NCT03776435</nct_id>
  </id_info>
  <brief_title>CT Carcinogenic Risk in Patients With Appendicitis</brief_title>
  <official_title>Carcinogenic Risk of CT in Patients With Appendicitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Bundang Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Research Foundation of Korea</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Seoul National University Bundang 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 purpose of this study is to compare the incidence rate of leukemia between CT-exposed and&#xD;
      CT-unexposed group in patients who underwent appendectomy in South Korea.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      South Korea has a single-payer healthcare system, administered by National Health Insurance&#xD;
      Service (NHIS). As healthcare providers in South Korea need to claim reimbursement to NHIS&#xD;
      for the vast majority of diagnostic and therapeutic procedures, the NHIS database enabled us&#xD;
      to construct a large cohort who did or did not undergo CT for appendicitis. The purpose of&#xD;
      this study is to compare the incidence rate of cancer between CT-exposed and CT-unexposed&#xD;
      group in patients who underwent appendectomy in South Korea.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 15, 2018</start_date>
  <completion_date type="Anticipated">May 15, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 15, 2020</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>Age and sex-standardized incidence rate ratio (IRR) for malignancies of hematologic system</measure>
    <time_frame>Cancer occurrence after a lag period (2 years)</time_frame>
    <description>Hematologic malignancies are categorized into lymphomas, multiple myeloma, leukemias, myelodysplasia and others using ICD-10 codes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Age and sex-standardized incidence rate ratio (IRR) for malignancies of abdominal organs</measure>
    <time_frame>Cancer occurrence after a lag period (2 years)</time_frame>
    <description>age and sex-standardized IRRs for malignancies of abdominal organs for CT-exposed versus unexposed patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Age and sex-standardized incidence rate ratio (IRR) for all cancers</measure>
    <time_frame>Cancer occurrence after a lag period (2 years)</time_frame>
    <description>age and sex-standardized IRRs for all cancers for CT-exposed versus unexposed patients.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Sensitivity analysis</measure>
    <time_frame>Cancer occurrence after different lag periods (6 months, 1 year, 3 years and 5 years)</time_frame>
    <description>Various lag periods will be applied for the outcomes.</description>
  </other_outcome>
  <other_outcome>
    <measure>Subgroup analysis by subsequent CT scans conducted more than 7 days after appendectomy</measure>
    <time_frame>CT undergone more than 7 days after appendectomy will be counted.</time_frame>
    <description>IRR in patients who underwent CT after appendectomy IRR in patients who did not undergo CT after appendectomy</description>
  </other_outcome>
  <other_outcome>
    <measure>Subgroup analysis</measure>
    <time_frame>Cancer occurrence after a lag period (2 years)</time_frame>
    <description>by age and sex</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">1000000</enrollment>
  <condition>Computed Tomography</condition>
  <condition>Carcinogenesis</condition>
  <condition>Radiation Exposure</condition>
  <condition>Appendicitis</condition>
  <arm_group>
    <arm_group_label>CT-exposed group</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>CT-unexposed group</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Abdomen CT</intervention_name>
    <description>Patients are divided into CT-exposed or unexposed group according to the presence of claims codes of abdominopelvic CT conducted within seven days before and after appendectomy. The seven-day threshold is arbitrarily determined considering the delay in the diagnosis of appendicitis and the postoperative examination for surgical complication.</description>
    <arm_group_label>CT-exposed group</arm_group_label>
    <arm_group_label>CT-unexposed group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who underwent appendectomy under the diagnosis of appendicitis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients will be entered in the cohort on the date of appendectomy under the diagnosis&#xD;
             of appendicitis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  (a) patients who had a cancer diagnosis before the date of appendectomy,&#xD;
&#xD;
          -  (b) those who had prior experience of CT examination more than 7 days before&#xD;
             appendectomy,&#xD;
&#xD;
          -  (c) those who had syndromes or diseases predisposing cancers,&#xD;
&#xD;
          -  (d) those whose diagnosis was changed to appendiceal cancer and&#xD;
&#xD;
          -  (e) those whose follow-up duration was shorter than a lag period.&#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>Ji Hoon Park, MD</last_name>
    <phone>82-10-8526-0650</phone>
    <email>pjihoon79@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kyung Hee Lee, MD</last_name>
    <phone>82-10-6686-8404</phone>
    <email>kyung8404@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Seoul National University Bunadang Hospital</name>
      <address>
        <city>Seongnam-Si</city>
        <state>Gyeonggi-do</state>
        <zip>463-707</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Min Jeong Jeong</last_name>
      <phone>82-31-787-7607</phone>
      <email>jeongminjeong1004@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>February 12, 2020</last_update_submitted>
  <last_update_submitted_qc>February 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Bundang Hospital</investigator_affiliation>
    <investigator_full_name>Ji Hoon Park</investigator_full_name>
    <investigator_title>Associated Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Appendicitis</mesh_term>
    <mesh_term>Carcinogenesis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03776435
org study id: AppyCTcancer
nct id: NCT03776435
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare the incidence rate of leukemia between CT-exposed and
      CT-unexposed group in patients who underwent appendectomy in South Korea.
South Korea has a single-payer healthcare system, administered by National Health Insurance
      Service (NHIS). As healthcare providers in South Korea need to claim reimbursement to NHIS
      for the vast majority of diagnostic and therapeutic procedures, the NHIS database enabled us
      to construct a large cohort who did or did not undergo CT for appendicitis. The purpose of
      this study is to compare the incidence rate of cancer between CT-exposed and CT-unexposed
      group in patients who underwent appendectomy in South Korea.
observational model: Cohort
time perspective: Retrospective
measure: Age and sex-standardized incidence rate ratio (IRR) for malignancies of hematologic system
time frame: Cancer occurrence after a lag period (2 years)
description: Hematologic malignancies are categorized into lymphomas, multiple myeloma, leukemias, myelodysplasia and others using ICD-10 codes.
measure: Age and sex-standardized incidence rate ratio (IRR) for malignancies of abdominal organs
time frame: Cancer occurrence after a lag period (2 years)
description: age and sex-standardized IRRs for malignancies of abdominal organs for CT-exposed versus unexposed patients.
measure: Age and sex-standardized incidence rate ratio (IRR) for all cancers
time frame: Cancer occurrence after a lag period (2 years)
description: age and sex-standardized IRRs for all cancers for CT-exposed versus unexposed patients.
measure: Sensitivity analysis
time frame: Cancer occurrence after different lag periods (6 months, 1 year, 3 years and 5 years)
description: Various lag periods will be applied for the outcomes.
measure: Subgroup analysis by subsequent CT scans conducted more than 7 days after appendectomy
time frame: CT undergone more than 7 days after appendectomy will be counted.
description: IRR in patients who underwent CT after appendectomy IRR in patients who did not undergo CT after appendectomy
measure: Subgroup analysis
time frame: Cancer occurrence after a lag period (2 years)
description: by age and sex
arm group label: CT-exposed group
arm group label: CT-unexposed group
intervention type: Radiation
intervention name: Abdomen CT
description: Patients are divided into CT-exposed or unexposed group according to the presence of claims codes of abdominopelvic CT conducted within seven days before and after appendectomy. The seven-day threshold is arbitrarily determined considering the delay in the diagnosis of appendicitis and the postoperative examination for surgical complication.
arm group label: CT-exposed group
arm group label: CT-unexposed group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Ji Hoon Park, MD
phone: 82-10-8526-0650
email: pjihoon79@gmail.com
last name: Kyung Hee Lee, MD
phone: 82-10-6686-8404
email: kyung8404@gmail.com
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Bundang Hospital
investigator full name: Ji Hoon Park
investigator title: Associated Professor
mesh term: Appendicitis
mesh term: Carcinogenesis
sharing ipd: No