CClinicalTrials.gg
Status unknownNCT03776435Updated Feb 17, 2020

CT Carcinogenic Risk in Patients With Appendicitis

An observational study in Computed Tomography, Carcinogenesis and Radiation Exposure, sponsored by Seoul National University Bundang Hospital. Status unknown at 1 site in Korea, Republic of. Per ClinicalTrials.gov, last updated 2020-02-17.

Sponsored by Seoul National University Bundang Hospital · Observational

The sponsor has not verified this record recently (last verified Feb 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,000,000
Sex
All
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Study summary

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.

Read the detailed description

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.

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Conditions studied

  • Computed Tomography
  • Carcinogenesis
  • Radiation Exposure
  • Appendicitis
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In context

Appendicitis

412 studies on the registry are indexed under Appendicitis; 62 are open to participants now.

This study's planned enrollment of 1,000,000 is above the median of 200 across 150 observational studies indexed under Appendicitis.

Browse Appendicitis studies →

Lead sponsor

Seoul National University Bundang Hospital is the lead sponsor of 368 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who underwent appendectomy under the diagnosis of appendicitis

Inclusion criteria

  • Patients will be entered in the cohort on the date of appendectomy under the diagnosis of appendicitis

Exclusion criteria

Exclusion Criteria:

  • (a) patients who had a cancer diagnosis before the date of appendectomy,
  • (b) those who had prior experience of CT examination more than 7 days before appendectomy,
  • (c) those who had syndromes or diseases predisposing cancers,
  • (d) those whose diagnosis was changed to appendiceal cancer and
  • (e) those whose follow-up duration was shorter than a lag period.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,000,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • CT-exposed group

    Radiation: Abdomen CT

  • CT-unexposed group

    Radiation: Abdomen CT

Interventions

  • RadiationAbdomen CT

    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.

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What researchers measure

Primary outcomes

  1. Age and sex-standardized incidence rate ratio (IRR) for malignancies of hematologic system

    Hematologic malignancies are categorized into lymphomas, multiple myeloma, leukemias, myelodysplasia and others using ICD-10 codes.

    Time frame: Cancer occurrence after a lag period (2 years)

Secondary outcomes

  1. Age and sex-standardized incidence rate ratio (IRR) for malignancies of abdominal organs

    age and sex-standardized IRRs for malignancies of abdominal organs for CT-exposed versus unexposed patients.

    Time frame: Cancer occurrence after a lag period (2 years)

  2. Age and sex-standardized incidence rate ratio (IRR) for all cancers

    age and sex-standardized IRRs for all cancers for CT-exposed versus unexposed patients.

    Time frame: Cancer occurrence after a lag period (2 years)

Other outcomes

  1. Sensitivity analysis

    Various lag periods will be applied for the outcomes.

    Time frame: Cancer occurrence after different lag periods (6 months, 1 year, 3 years and 5 years)

  2. Subgroup analysis by subsequent CT scans conducted more than 7 days after appendectomy

    IRR in patients who underwent CT after appendectomy IRR in patients who did not undergo CT after appendectomy

    Time frame: CT undergone more than 7 days after appendectomy will be counted.

  3. Subgroup analysis

    by age and sex

    Time frame: Cancer occurrence after a lag period (2 years)

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Study locations

1 of 1 sites recruiting
  • Seoul National University Bunadang Hospital
    Seongnam-Si, Gyeonggi-do 463-707, Korea, Republic of
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03776435
Lead sponsor
Seoul National University Bundang Hospital
Collaborators
National Research Foundation of Korea
Responsible party
Ji Hoon Park (Associated Professor, Seoul National University Bundang Hospital) — Principal investigator
First posted
Dec 14, 2018
Start date
Jan 15, 2018
Primary completion
Dec 15, 2020 (estimated)
Completion
May 15, 2021 (estimated)
Last update
Feb 17, 2020

Study contacts

Ji Hoon Park, MD
Contact
pjihoon79@gmail.com
82-10-8526-0650
Kyung Hee Lee, MD
Contact
kyung8404@gmail.com
82-10-6686-8404

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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