Computed TomographyNCT03776435
CT Carcinogenic Risk in Patients With Appendicitis
An observational study of Computed Tomography and Carcinogenesis, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial 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 more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Computed Tomography, Carcinogenesis, Radiation Exposure
- What is being tested?
- Abdomen CT
- Type of treatment
- Surgery or procedure
- How many people
- 1,000,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Jan 2018to 15 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who underwent appendectomy under the diagnosis of appendicitis
Who may be able to join
- Patients will be entered in the cohort on the date of appendectomy under the diagnosis of appendicitis
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bunadang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Min Jeong Jeong, 82-31-787-7607, jeongminjeong1004@gmail.com
About this study
Official title: Carcinogenic Risk of CT in Patients With Appendicitis
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.
- Conditions
- Computed Tomography, Carcinogenesis, Radiation Exposure, Appendicitis
- Being tested
- Abdomen CT
- Medical subject headings
- Carcinogenesis, Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdomen CTRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| CT-exposed group | Not described Receives: Radiation: Abdomen CT | |
| CT-unexposed group | Not described Receives: Radiation: Abdomen CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Cancer occurrence after a lag period (2 years)
Secondary outcomes (2)
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.
Measured: Cancer occurrence after a lag period (2 years)
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.
Measured: Cancer occurrence after a lag period (2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study start15 Jan 2018
- Primary completion15 Dec 2020 (estimated)
- Study completion15 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Computed TomographyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Foundation of Korea
- Responsible party
- Principal investigator, Ji Hoon Park, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03776435
- Sponsor's protocol ID
- AppyCTcancer
- Status last verified
- Feb 2020
- First submitted
- 13 Dec 2018
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carcinogenic Risk of CT in Patients With Appendicitis
- ClinicalTrials.gov ID
- NCT03776435
- Acronym / sponsor ID
- AppyCTcancer
- Conditions
- Computed Tomography, Carcinogenesis, Radiation Exposure, Appendicitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000,000 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- National Research Foundation of Korea
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 15 Dec 2020 (estimated)
- Study completion
- 15 May 2021 (estimated)
- First posted
- 14 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT-exposed group | – | Radiation: Abdomen CT |
| CT-unexposed group | – | Radiation: Abdomen CT |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent appendectomy under the diagnosis of appendicitis
Key inclusion criteria (1 listed)
- Patients will be entered in the cohort on the date of appendectomy under the diagnosis of appendicitis
Key exclusion criteria (5 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdomen CTPatients 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. | Radiation | CT-exposed group, CT-unexposed group |
Primary outcome
Age and sex-standardized incidence rate ratio (IRR) for malignancies of hematologic system
Time frame: Cancer occurrence after a lag period (2 years)
Hematologic malignancies are categorized into lymphomas, multiple myeloma, leukemias, myelodysplasia and others using ICD-10 codes.
2 secondary outcomes
Age and sex-standardized incidence rate ratio (IRR) for malignancies of abdominal organs
Time frame: Cancer occurrence after a lag period (2 years)
Age and sex-standardized incidence rate ratio (IRR) for all cancers
Time frame: Cancer occurrence after a lag period (2 years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Computed Tomography and Carcinogenesis, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ji Hoon Park, MD (82-10-8526-0650, pjihoon79@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age and sex-standardized incidence rate ratio (IRR) for malignancies of hematologic system (time frame: Cancer occurrence after a lag period (2 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.