Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-03-01 @ 1:26 PM
Study NCT ID:
NCT03776435
Status:
UNKNOWN
Last Update Posted:
2020-02-17
First Post:
2018-12-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CT Carcinogenic Risk in Patients With Appendicitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063646', 'term': 'Carcinogenesis'}, {'id': 'D001064', 'term': 'Appendicitis'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002429', 'term': 'Cecal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2021-05-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-12', 'studyFirstSubmitDate': '2018-12-13', 'studyFirstSubmitQcDate': '2018-12-13', 'lastUpdatePostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Sensitivity analysis', 'timeFrame': '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', 'timeFrame': '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', 'timeFrame': 'Cancer occurrence after a lag period (2 years)', 'description': 'by age and sex'}], 'primaryOutcomes': [{'measure': 'Age and sex-standardized incidence rate ratio (IRR) for malignancies of hematologic system', 'timeFrame': '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.'}], 'secondaryOutcomes': [{'measure': 'Age and sex-standardized incidence rate ratio (IRR) for malignancies of abdominal organs', 'timeFrame': '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', 'timeFrame': 'Cancer occurrence after a lag period (2 years)', 'description': 'age and sex-standardized IRRs for all cancers for CT-exposed versus unexposed patients.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Computed Tomography', 'Carcinogenesis', 'Radiation Exposure', 'Appendicitis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent appendectomy under the diagnosis of appendicitis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients will be entered in the cohort on the date of appendectomy under the diagnosis of appendicitis\n\nExclusion Criteria:\n\n* (a) patients who had a cancer diagnosis before the date of appendectomy,\n* (b) those who had prior experience of CT examination more than 7 days before appendectomy,\n* (c) those who had syndromes or diseases predisposing cancers,\n* (d) those whose diagnosis was changed to appendiceal cancer and\n* (e) those whose follow-up duration was shorter than a lag period.'}, 'identificationModule': {'nctId': 'NCT03776435', 'briefTitle': 'CT Carcinogenic Risk in Patients With Appendicitis', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'Carcinogenic Risk of CT in Patients With Appendicitis', 'orgStudyIdInfo': {'id': 'AppyCTcancer'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CT-exposed group', 'interventionNames': ['Radiation: Abdomen CT']}, {'label': 'CT-unexposed group', 'interventionNames': ['Radiation: Abdomen CT']}], 'interventions': [{'name': 'Abdomen CT', 'type': 'RADIATION', '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.', 'armGroupLabels': ['CT-exposed group', 'CT-unexposed group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Min Jeong Jeong', 'role': 'CONTACT', 'email': 'jeongminjeong1004@gmail.com', 'phone': '82-31-787-7607'}], 'facility': 'Seoul National University Bunadang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'centralContacts': [{'name': 'Ji Hoon Park, MD', 'role': 'CONTACT', 'email': 'pjihoon79@gmail.com', 'phone': '82-10-8526-0650'}, {'name': 'Kyung Hee Lee, MD', 'role': 'CONTACT', 'email': 'kyung8404@gmail.com', 'phone': '82-10-6686-8404'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Research Foundation of Korea', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated Professor', 'investigatorFullName': 'Ji Hoon Park', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}