Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:31 AM
Study NCT ID:
NCT06559202
Status:
COMPLETED
Last Update Posted:
2024-08-19
First Post:
2024-08-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Inguinal and Axillary LN Size Distribution
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 133}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-14', 'studyFirstSubmitDate': '2024-08-10', 'studyFirstSubmitQcDate': '2024-08-14', 'lastUpdatePostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Correlation between inguinal and axillary LN sizes', 'timeFrame': 'On the day when chest and abdominopelvic CT was performed during the study period from 1st SEP 2022 to 30th NOV 2022', 'description': 'Correlation between the long-axis diameter of the largest LNs in inguinal area and those in axillary area'}, {'measure': 'Correlation between inguinal LN size and age', 'timeFrame': 'On the day when chest and abdominopelvic CT was performed during the study period from 1st SEP 2022 to 30th NOV 2022', 'description': 'Correlation between the long-axis diameter of the largest inguinal LN and age'}, {'measure': 'Correlation between axillary LN size and age', 'timeFrame': 'On the day when chest and abdominopelvic CT was performed during the study period from 1st SEP 2022 to 30th NOV 2022', 'description': 'Correlation between the long-axis diameter of the largest axillary LN and age'}, {'measure': 'Correlation between inguinal LN size and height', 'timeFrame': 'On the day when chest and abdominopelvic CT was performed during the study period from 1st SEP 2022 to 30th NOV 2022', 'description': 'Correlation between the long-axis diameter of the largest inguinal LN and height'}, {'measure': 'Correlation between axillary LN size and height', 'timeFrame': 'On the day when chest and abdominopelvic CT was performed during the study period from 1st SEP 2022 to 30th NOV 2022', 'description': 'Correlation between the long-axis diameter of the largest axillary LN and height'}, {'measure': 'Correlation between inguinal LN size and BMI', 'timeFrame': 'On the day when chest and abdominopelvic CT was performed during the study period from 1st SEP 2022 to 30th NOV 2022', 'description': 'Correlation between the long-axis diameter of the largest inguinal LN and BMI'}, {'measure': 'Correlation between axillary LN size and BMI', 'timeFrame': 'On the day when chest and abdominopelvic CT was performed during the study period from 1st SEP 2022 to 30th NOV 2022', 'description': 'Correlation between the long-axis diameter of the largest axillary LN and BMI'}, {'measure': 'Correlation between inguinal LN size and weight', 'timeFrame': 'On the day when chest and abdominopelvic CT was performed during the study period from 1st SEP 2022 to 30th NOV 2022', 'description': 'Correlation between the long-axis diameter of the largest inguinal LN and weight'}, {'measure': 'Correlation between axillary LN size and weight', 'timeFrame': 'On the day when chest and abdominopelvic CT was during the study period from 1st SEP 2022 to 30th NOV 2022', 'description': 'Correlation between the long-axis diameter of the largest axillary LN and weight'}], 'primaryOutcomes': [{'measure': 'Inguinal LN size', 'timeFrame': 'On the day when chest and abdominopelvic CT was performed during the study period from 1st SEP 2022 to 30th NOV 2022', 'description': 'The long-axis diameter of the largest inguinal lymph node'}, {'measure': 'Axillary LN size', 'timeFrame': 'On the day when chest and abdominopelvic CT was performed during the study period from 1st SEP 2022 to 30th NOV 2022', 'description': 'The long-axis diameter of the largest axillary lymph node'}], 'secondaryOutcomes': [{'measure': 'Subjects with inguinal LN size ≥ 10mm', 'timeFrame': 'On the day when chest and abdominopelvic CT was performed during the study period from 1st SEP 2022 to 30th NOV 2022', 'description': 'The number of subjects in whom the long-axis diameter of the largest inguinal lymph node is 10 mm or more.'}, {'measure': 'Subjects with axillary LN size ≥ 10mm', 'timeFrame': 'On the day when chest and abdominopelvic CT was performed during the study period from 1st SEP 2022 to 30th NOV 2022', 'description': 'The number of subjects in whom the long-axis diameter of the largest axillary lymph node is 10 mm or more.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lymph nodes', 'immunotherapy', 'intralymphatic immunotherapy', 'computed tomography'], 'conditions': ['Lymph Nodes']}, 'descriptionModule': {'briefSummary': 'Recently, intralymphatic allergen-specific immunotherapy (ILIT) showed promising treatment outcomes for allergic rhinoconjunctivitis. However, the normal size distribution of superficial lymph nodes (LNs) on the trunk that are potential target LNs for ILIT has not been evaluated.\n\nThe objective of this study is to investigate the distribution of LN size in inguinal and axillary area.', 'detailedDescription': 'In this study, the long-axis diameters of the largest LNs in the inguinal and axillary areas were retrospectively measured in subjects who underwent chest and abdominopelvic computed tomography on the same day for health screening purposes from September 2022 to November 2022.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'subjects who underwent chest and abdominopelvic computed tomography on the same day for health screening purposes', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subjects who underwent chest and abdominopelvic computed tomography on the same day for health screening purposes\n\nExclusion Criteria:\n\n* Malignancy\n* Follow-up less than 1-year'}, 'identificationModule': {'nctId': 'NCT06559202', 'briefTitle': 'Inguinal and Axillary LN Size Distribution', 'organization': {'class': 'OTHER', 'fullName': 'Gachon University Gil Medical Center'}, 'officialTitle': 'Evaluation of Inguinal and Axillary Lymph Node Size Distribution for Safe Intralymphatic Injection', 'orgStudyIdInfo': {'id': 'GDIRB2024-098'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CT group', 'description': 'Participants who underwent chest and abdominopelvic computed tomography on the same day for health screening purposes', 'interventionNames': ['Diagnostic Test: chest and abdominoplevic CT']}], 'interventions': [{'name': 'chest and abdominoplevic CT', 'type': 'DIAGNOSTIC_TEST', 'description': 'chest and abdominopelvic computed tomography on the same day for health screening purposes', 'armGroupLabels': ['CT group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21565', 'city': 'Incheon', 'country': 'South Korea', 'facility': 'Gachon University Gil Medical Center', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}], 'overallOfficials': [{'name': 'So Hyun Park, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gachon University Gil Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'I think that IPD of this observational retrospective mono-center pilot study needs not be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gachon University Gil Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dankook University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sangmin Lee, MD', 'investigatorAffiliation': 'Gachon University Gil Medical Center'}}}}