- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04213001
Diagnostic Contribution of Ultrasonography in Breast Cancer-Related Lymphedema
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients with unilateral breast cancer-related lymphedema will be included in the study. The circumferences will be measured with a measuring tape from wrist ulnar styloid to axilla at 4 cm intervals. The point where the difference between the upper extremities was highest and the control point with no difference in the lower extremities will be marked. Ultrasonographic skin and subcutaneous thickness measurements will be performed from 4 quadrants; volar medial-lateral and dorsal medial-lateral sides of the extremity, with the probe placed transverse and perpendicular to the skin at the marked points.
The severity of lymphedema was graded ultrasonographically according to the SEG scale. (Stage 0: No increase in echogenicity in the subcutaneous layer. That is, subcutaneous fat is observed as black. Stage 1: Diffuse increase in echogenicity, but identifiable horizontal or oblique-oriented echogenic lines caused by bundles of connective tissue can be seen. Stage 2: A widespread increase in echogenicity echogenic lines cannot be identified.) Spearman test was used for correlations and Receiver Operating Characteristics (ROC) curve analysis was used to estimate the diagnostic accuracy. Sensitivity and specificity were calculated using a statistically significant threshold. Differences between ultrasonographic measurements between control points in lower extremities were compared with Wilcoxon test.
The minimum number of patients to be included in the study, according to the G-Power program, effect size d = 0.5, alpha-α = 0.05 and power 0.80 was calculated to be at least 34.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Inciralti
-
İzmir, Inciralti, Turkey, 35340
- Dokuz Eylul University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- To be diagnosed with breast cancer-related unilateral lymphedema
- Being over 18 years old
- Having a female gender
Exclusion Criteria:
- Bilateral breast cancer
- Existing upper extremity infection
- Lymphangitis
- Refusal to participate in the study
- Presence of edema in lower extremity
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: measure
circumference measure, ultrasonographic measure
|
ultrasonographic measurement- Subcutaneous ultrasound echogenicity (SEG) and Skin and subcutaneous thickness measurement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ultrasonographic measurement
Time Frame: baseline
|
- Subcutaneous ultrasound echogenicity (SEG) and Skin and subcutaneous thickness measurement
|
baseline
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DokuzEUBanuNihan
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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