NCT03523494

Brief Summary

Development of lympho-proliferation reticulation quantification using CT.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2017

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

January 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2018

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 14, 2018

Completed
Last Updated

March 8, 2019

Status Verified

March 1, 2019

Enrollment Period

1.2 years

First QC Date

April 17, 2018

Last Update Submit

March 6, 2019

Conditions

LymphedemaSecondary LymphedemaCT

Outcome Measures

Primary Outcomes (1)

  • Reticulation Ratio from Computerized Tomography

    calculated value of reticulation

    1 week

Secondary Outcomes (1)

  • Multi-frequency bio-electric impedance analysis

    1 week

Other Outcomes (3)

  • International Society of Lymphology stage

    1 week

  • lymphascintigraphy stage

    1 week

  • circumference between normal and involved limbs

    1 week

Study Arms (2)

Normal limb

Normal

Abnormal limb

Lymph Edema

Eligibility Criteria

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

In- and out-patients who was diagnosed a secondary lymphoma and undertook CT on their limbs

You may qualify if:

  • In- and out-patients who was diagnosed a secondary lymphoma and undertook CT on their limbs

You may not qualify if:

  • Primary lymph edema (congenital lymph edema, lymph edema precox, lymph edema tarda)
  • Lymph edema simultaneously involving both limbs
  • Patients who undertook implantation of electrical devices such as cardic pacemakers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ulsan University Hospital

Ulsan, 682-714, South Korea

Location

Related Publications (1)

  • Koo KI, Ko MH, Lee Y, Son HW, Lee S, Hwang CH. Comparison of a novel algorithm quantitatively estimating epifascial fibrosis in three-dimensional computed tomography images to other clinical lymphedema grading methods. PLoS One. 2019 Dec 10;14(12):e0224457. doi: 10.1371/journal.pone.0224457. eCollection 2019.

    PMID: 31821335DERIVED

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Chang Ho Hwang, M.D., Ph.D.

    Ulsan University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, PhD and MD

Study Record Dates

First Submitted

April 17, 2018

First Posted

May 14, 2018

Study Start

January 1, 2017

Primary Completion

March 30, 2018

Study Completion

March 30, 2018

Last Updated

March 8, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)