NCT06559202

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
133

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 2, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 19, 2024

Completed
Last Updated

August 19, 2024

Status Verified

August 1, 2024

Enrollment Period

3 months

First QC Date

August 10, 2024

Last Update Submit

August 14, 2024

Conditions

Keywords

lymph nodesimmunotherapyintralymphatic immunotherapycomputed tomography

Outcome Measures

Primary Outcomes (2)

  • Inguinal LN size

    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

    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 Outcomes (2)

  • Subjects with inguinal LN size ≥ 10mm

    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

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

Other Outcomes (9)

  • Correlation between inguinal and axillary LN sizes

    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

    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

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

  • +6 more other outcomes

Study Arms (1)

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

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

CT group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Malignancy
  • Follow-up less than 1-year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gachon University Gil Medical Center

Incheon, 21565, South Korea

Location

Study Officials

  • So Hyun Park, MD, PhD

    Gachon University Gil Medical Center

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 10, 2024

First Posted

August 19, 2024

Study Start

September 2, 2022

Primary Completion

November 30, 2022

Study Completion

November 30, 2022

Last Updated

August 19, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

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

Locations