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CompletedNCT06559202Updated Aug 19, 2024

Inguinal and Axillary LN Size Distribution

An observational study in Lymph Nodes, sponsored by Gachon University Gil Medical Center. Completed at 1 site in Korea, Republic of. Per ClinicalTrials.gov, last updated 2024-08-19.

Sponsored by Gachon University Gil Medical Center · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
133
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Lymph Nodes

Keywords

  • lymph nodes
  • immunotherapy
  • intralymphatic immunotherapy
  • computed tomography
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Malignancy
  • Follow-up less than 1-year
04

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
133 participants (actual)
Patient registry
No

Groups and cohorts

  • CT group

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

    Diagnostic Test: chest and abdominoplevic CT

Interventions

  • Diagnostic testchest and abdominoplevic CT

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

05

What researchers measure

Primary outcomes

  1. Inguinal LN size

    The long-axis diameter of the largest inguinal lymph node

    Time frame: On the day when chest and abdominopelvic CT was performed during the study period from 1st SEP 2022 to 30th NOV 2022

  2. Axillary LN size

    The long-axis diameter of the largest axillary lymph node

    Time frame: On the day when chest and abdominopelvic CT was performed during the study period from 1st SEP 2022 to 30th NOV 2022

Secondary outcomes

  1. Subjects with inguinal LN size ≥ 10mm

    The number of subjects in whom the long-axis diameter of the largest inguinal lymph node is 10 mm or more.

    Time frame: On the day when chest and abdominopelvic CT was performed during the study period from 1st SEP 2022 to 30th NOV 2022

  2. Subjects with axillary LN size ≥ 10mm

    The number of subjects in whom the long-axis diameter of the largest axillary lymph node is 10 mm or more.

    Time frame: On the day when chest and abdominopelvic CT was performed during the study period from 1st SEP 2022 to 30th NOV 2022

Other outcomes

  1. Correlation between inguinal and axillary LN sizes

    Correlation between the long-axis diameter of the largest LNs in inguinal area and those in axillary area

    Time frame: On the day when chest and abdominopelvic CT was performed during the study period from 1st SEP 2022 to 30th NOV 2022

  2. Correlation between inguinal LN size and age

    Correlation between the long-axis diameter of the largest inguinal LN 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

  3. Correlation between axillary LN size and age

    Correlation between the long-axis diameter of the largest axillary LN 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

  4. Correlation between inguinal LN size and height

    Correlation between the long-axis diameter of the largest inguinal LN 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

  5. Correlation between axillary LN size and height

    Correlation between the long-axis diameter of the largest axillary LN 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

  6. Correlation between inguinal LN size and BMI

    Correlation between the long-axis diameter of the largest inguinal LN 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

  7. Correlation between axillary LN size and BMI

    Correlation between the long-axis diameter of the largest axillary LN 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

  8. Correlation between inguinal LN size and weight

    Correlation between the long-axis diameter of the largest inguinal LN 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

  9. Correlation between axillary LN size and weight

    Correlation between the long-axis diameter of the largest axillary LN 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

06

Study locations

1 site
  • Gachon University Gil Medical Center
    Incheon, 21565, Korea, Republic of
07

References and documents

Individual participant data

Plan to share: No — I think that IPD of this observational retrospective mono-center pilot study needs not be shared.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06559202
Lead sponsor
Gachon University Gil Medical Center
Collaborators
Dankook University
Responsible party
Sangmin Lee, MD (Professor, Gachon University Gil Medical Center) — Principal investigator
First posted
Aug 19, 2024
Start date
Sep 2, 2022
Primary completion
Nov 30, 2022
Completion
Nov 30, 2022
Last update
Aug 19, 2024

Study contacts

So Hyun Park, MD, PhD
study director · Gachon University Gil Medical Center

Oversight

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

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