Lymph NodesNCT06559202
Inguinal and Axillary LN Size Distribution
An observational study of Lymph Nodes, run by Gachon University Gil Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Lymph Nodes
- What is being tested?
- chest and abdominoplevic CT
- How many people
- 133 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Sep 2022to 30 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: subjects who underwent chest and abdominopelvic computed tomography on the same day for health screening purposes
Who may be able to join
- subjects who underwent chest and abdominopelvic computed tomography on the same day for health screening purposes
Who cannot join
- Malignancy
- Follow-up less than 1-year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Lymph Nodes
- Being tested
- chest and abdominoplevic CT
- Keywords
- lymph nodes, immunotherapy, intralymphatic immunotherapy, computed tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chest and abdominoplevic CTDiagnostic test
chest and abdominopelvic computed tomography on the same day for health screening purposes
| Study group | Role | What they receive |
|---|---|---|
| CT group | Participants who underwent chest and abdominopelvic computed tomography on the same day for health screening purposes Receives: Diagnostic Test: chest and abdominoplevic CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inguinal LN size
The long-axis diameter of the largest inguinal lymph node
Measured: 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
Measured: 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
The number of subjects in whom the long-axis diameter of the largest inguinal lymph node is 10 mm or more.
Measured: 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
The number of subjects in whom the long-axis diameter of the largest axillary lymph node is 10 mm or more.
Measured: On the day when chest and abdominopelvic CT was performed during the study period from 1st SEP 2022 to 30th NOV 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start2 Sep 2022
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymph NodesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dankook University
- Responsible party
- Principal investigator, Sangmin Lee, MD, Gachon University Gil Medical Center
- Investigators
- So Hyun Park, MD, PhD, Study director, Gachon University Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06559202
- Sponsor's protocol ID
- GDIRB2024-098
- Status last verified
- Aug 2024
- First submitted
- 10 Aug 2024
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I think that IPD of this observational retrospective mono-center pilot study needs not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Inguinal and Axillary Lymph Node Size Distribution for Safe Intralymphatic Injection
- ClinicalTrials.gov ID
- NCT06559202
- Acronym / sponsor ID
- GDIRB2024-098
- Conditions
- Lymph Nodes
- Keywords
- lymph nodes, immunotherapy, intralymphatic immunotherapy, computed tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Collaborators
- Dankook University
- Study start
- 2 Sep 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT group | – | Diagnostic Test: chest and abdominoplevic CTParticipants who underwent chest and abdominopelvic computed tomography on the same day for health screening purposes |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- subjects who underwent chest and abdominopelvic computed tomography on the same day for health screening purposes
Key inclusion criteria (1 listed)
- subjects who underwent chest and abdominopelvic computed tomography on the same day for health screening purposes
Key exclusion criteria (2 listed)
- Malignancy
- Follow-up less than 1-year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chest and abdominoplevic CTchest and abdominopelvic computed tomography on the same day for health screening purposes | Diagnostic test | CT group |
Primary outcome
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
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Individual participant dataSharing planned: No. I think that IPD of this observational retrospective mono-center pilot study needs not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
So Hyun Park, MD, PhD study director
Gachon University Gil Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymph Nodes, run by Gachon University Gil Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.