Inguinal and Axillary LN Size Distribution

August 14, 2024 updated by: Sangmin Lee, MD, Gachon University Gil Medical Center

Evaluation of Inguinal and Axillary Lymph Node Size Distribution for Safe Intralymphatic Injection

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.

The objective of this study is to investigate the distribution of LN size in inguinal and axillary area.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

133

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Incheon, Korea, Republic of, 21565
        • Gachon University Gil Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

subjects who underwent chest and abdominopelvic computed tomography on the same day for health screening purposes

Description

Inclusion Criteria:

  • subjects who underwent chest and abdominopelvic computed tomography on the same day for health screening purposes

Exclusion Criteria:

  • Malignancy
  • Follow-up less than 1-year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CT group
Participants who underwent chest and abdominopelvic computed tomography on the same day for health screening purposes
chest and abdominopelvic computed tomography on the same day for health screening purposes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inguinal LN size
Time Frame: On the day when chest and abdominopelvic CT was performed during the study period from 1st SEP 2022 to 30th NOV 2022
The long-axis diameter of the largest inguinal lymph node
On the day when chest and abdominopelvic CT was performed during the study period from 1st SEP 2022 to 30th NOV 2022
Axillary LN size
Time Frame: On the day when chest and abdominopelvic CT was performed during the study period from 1st SEP 2022 to 30th NOV 2022
The long-axis diameter of the largest axillary lymph node
On the day when chest and abdominopelvic CT was performed during the study period from 1st SEP 2022 to 30th NOV 2022

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjects with inguinal LN size ≥ 10mm
Time Frame: On the day when chest and abdominopelvic CT was performed during the study period from 1st SEP 2022 to 30th NOV 2022
The number of subjects in whom the long-axis diameter of the largest inguinal lymph node is 10 mm or more.
On the day when chest and abdominopelvic CT was performed during the study period from 1st SEP 2022 to 30th NOV 2022
Subjects with axillary LN size ≥ 10mm
Time Frame: On the day when chest and abdominopelvic CT was performed during the study period from 1st SEP 2022 to 30th NOV 2022
The number of subjects in whom the long-axis diameter of the largest axillary lymph node is 10 mm or more.
On the day when chest and abdominopelvic CT was performed during the study period from 1st SEP 2022 to 30th NOV 2022

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between inguinal and axillary LN sizes
Time Frame: On the day when chest and abdominopelvic CT was performed during the study period from 1st SEP 2022 to 30th NOV 2022
Correlation between the long-axis diameter of the largest LNs in inguinal area and those in axillary area
On the day when chest and abdominopelvic CT was performed during the study period from 1st SEP 2022 to 30th NOV 2022
Correlation between inguinal LN size and age
Time Frame: On the day when chest and abdominopelvic CT was performed during the study period from 1st SEP 2022 to 30th NOV 2022
Correlation between the long-axis diameter of the largest inguinal LN and age
On the day when chest and abdominopelvic CT was performed during the study period from 1st SEP 2022 to 30th NOV 2022
Correlation between axillary LN size and age
Time Frame: On the day when chest and abdominopelvic CT was performed during the study period from 1st SEP 2022 to 30th NOV 2022
Correlation between the long-axis diameter of the largest axillary LN and age
On the day when chest and abdominopelvic CT was performed during the study period from 1st SEP 2022 to 30th NOV 2022
Correlation between inguinal LN size and height
Time Frame: On the day when chest and abdominopelvic CT was performed during the study period from 1st SEP 2022 to 30th NOV 2022
Correlation between the long-axis diameter of the largest inguinal LN and height
On the day when chest and abdominopelvic CT was performed during the study period from 1st SEP 2022 to 30th NOV 2022
Correlation between axillary LN size and height
Time Frame: On the day when chest and abdominopelvic CT was performed during the study period from 1st SEP 2022 to 30th NOV 2022
Correlation between the long-axis diameter of the largest axillary LN and height
On the day when chest and abdominopelvic CT was performed during the study period from 1st SEP 2022 to 30th NOV 2022
Correlation between inguinal LN size and BMI
Time Frame: On the day when chest and abdominopelvic CT was performed during the study period from 1st SEP 2022 to 30th NOV 2022
Correlation between the long-axis diameter of the largest inguinal LN and BMI
On the day when chest and abdominopelvic CT was performed during the study period from 1st SEP 2022 to 30th NOV 2022
Correlation between axillary LN size and BMI
Time Frame: On the day when chest and abdominopelvic CT was performed during the study period from 1st SEP 2022 to 30th NOV 2022
Correlation between the long-axis diameter of the largest axillary LN and BMI
On the day when chest and abdominopelvic CT was performed during the study period from 1st SEP 2022 to 30th NOV 2022
Correlation between inguinal LN size and weight
Time Frame: On the day when chest and abdominopelvic CT was performed during the study period from 1st SEP 2022 to 30th NOV 2022
Correlation between the long-axis diameter of the largest inguinal LN and weight
On the day when chest and abdominopelvic CT was performed during the study period from 1st SEP 2022 to 30th NOV 2022
Correlation between axillary LN size and weight
Time Frame: On the day when chest and abdominopelvic CT was during the study period from 1st SEP 2022 to 30th NOV 2022
Correlation between the long-axis diameter of the largest axillary LN and weight
On the day when chest and abdominopelvic CT was during the study period from 1st SEP 2022 to 30th NOV 2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Study Director: So Hyun Park, MD, PhD, Gachon University Gil Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2022

Primary Completion (Actual)

November 30, 2022

Study Completion (Actual)

November 30, 2022

Study Registration Dates

First Submitted

August 10, 2024

First Submitted That Met QC Criteria

August 14, 2024

First Posted (Actual)

August 19, 2024

Study Record Updates

Last Update Posted (Actual)

August 19, 2024

Last Update Submitted That Met QC Criteria

August 14, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • GDIRB2024-098

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

I think that IPD of this observational retrospective mono-center pilot study needs not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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