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CompletedNCT03676127Updated Dec 20, 2018

Diagnostic Accuracy of Dermal Thickness in Lymphedema

An observational study in Lymphedema of Upper Arm and Breast Cancer, sponsored by Marmara University. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-12-20.

Sponsored by Marmara University · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
43
Ages
18 Years to 80 Years
Sex
Female
01

Study summary

Ultrasound is an easily feasible noninvasive technique which is widely used in rehabilitation settings. Measurement of dermal thickness via ultrasound can be less time consuming than volume measurements with water displacement and circumference measurements. Measurement of subcutaneous tissue thickness were used for both assessment and treatment outcome. Recently reliability of ultrasound examination of thickness of the skin and subcutaneous tissue were studied by Han et al. However, diagnostic accuracy of this method has not been studied before. Early identification of breast cancer related lymphedema to start treatment earlier is critical. Consequently, reliability and diagnostic accuracy of the assessment techniques of lymphedema is crucial to evaluate both severity at the time of diagnosis, and later effectiveness of treatment. The aim of this study was to establish diagnostic accuracy of between side differences of ultrasonographic dermal thickness measurements in breast cancer related arm lymphedema.

Read the detailed description

Breast cancer related arm lymphedema is a potential sequalae from the treatment of breast cancer which is characterized by the accumulation of protein-rich lymphatic fluid in the extracellular spaces. It may occur in almost 40% of the patients who have undergone breast cancer surgery or radiation therapy. Breast cancer related lymphedema may appear in the upper extremity, as well as in the ipsilateral upper quadrant and remaining breast tissue. Clinically, the diagnosis of lymphedema is based mainly on patient history and self-report of symptoms, visual inspection and skin palpation, and the determination of volume differences between both limbs. The most widely accepted measure of lymphedema is limb volume compared with that of the unaffected limb or compared with that of the same limb. Sequential circumference measurements along designated measure points are widely used in clinical practice. Limb volumes can be calculated or estimated based on a truncated cone formula. Volumetry by means of water displacement is considered the golden standard. The most common criterion for lymphedema diagnosis is a volume difference of 200 mL. Circumference measurements and the estimated volume were found to be reliable and highly correlated with each other. However, these volume measurements are not only influenced by fluid changes but also by compositional changes of muscle mass, bone, or fat. Also, water displacement is too cumbersome and messy to be used in routine clinical practice.

Ultrasound is an easily feasible noninvasive technique which is widely used in rehabilitation settings. Measurement of dermal thickness via ultrasound can be less time consuming than volume measurements with water displacement and circumference measurements. Measurement of subcutaneous tissue thickness were used for both assessment and treatment outcome. Recently reliability of ultrasound examination of thickness of the skin and subcutaneous tissue were studied by Han et al. However, diagnostic accuracy of this method has not been studied before. Early identification of breast cancer related lymphedema to start treatment earlier is critical. Consequently, reliability and diagnostic accuracy of the assessment techniques of lymphedema is crucial to evaluate both severity at the time of diagnosis, and later effectiveness of treatment. The aim of this study was to establish diagnostic accuracy of between side differences of ultrasonographic dermal thickness measurements in breast cancer related arm lymphedema. Patients with breast cancer related lymphedema will be included. Lymphedema of the limbs will be assessed using the circumferential method. The circumferential upper limb measurementswill be carried out with the arm abducted at 30°, starting at the level of the carpometacarpal joint, every 5 cm proximal to this point along both limbs. Then, a computer program (limb volumes professional version 5.0) will be used to convert these values into limb volumes in milliliters. Differences in volume of affected and unaffected sides was defined as edema (volume difference). The criterion for lymphedema diagnosis is volume difference of 200 mL. Ultrasonographic dermal thickness measurements will be performed from medial forearm. Differences of the affected and unaffected sides will be calculated. The circumference measurement method and the thickness of the skin of the edematous limb by using the ultrasound and the truncated cone method by using circumference measurements will be compared to evaluate the diagnostic accuracy of between side differences of ultrasonographic dermal thickness measurements in breast cancer related arm lymphedema.

02

Conditions studied

  • Lymphedema of Upper Arm
  • Breast Cancer

Keywords

  • assessment
  • breast cancer
  • diagnosis
  • lymphedema
  • measurement
  • ultrasound
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 43 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Marmara University is the lead sponsor of 576 studies on the registry; 136 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with breast cancer related lymphedema

Inclusion criteria

  1. Patients with unilateral postmastectomy lymphedema

Exclusion criteria

Exclusion Criteria:

  1. Bilateral lymphedema
  2. The patients who had known systemic edemagenic conditions (e.g., cardiac/hepatic/renal failure, terminal cancer, on chemotherapy), and/or with cancer recurrence
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
43 participants (actual)
Patient registry
No

Groups and cohorts

  • Study Group

    ultrasonographic dermal thickness measurements in patients with unilateral breast cancer related lymphedema

    Other: ultrasonographic dermal thickness measurements

Interventions

  • Otherultrasonographic dermal thickness measurements

    ultrasonographic dermal thickness measurements

06

What researchers measure

Primary outcomes

  1. Area under curve

    Area under curve

    Time frame: Day 0

Secondary outcomes

  1. Sensivity of between side differences of ultrasonographic dermal thickness measurements

    Sensivity of between side differences of ultrasonographic dermal thickness measurements

    Time frame: Day 0

  2. Specificity of between side differences of ultrasonographic dermal thickness measurements

    Specificity of between side differences of ultrasonographic dermal thickness measurements

    Time frame: Day 0

  3. Interlimb volume difference

    Interlimb volume differencedetected via truncated cone method from circumference measurements

    Time frame: Day 0

  4. between side differences of ultrasonographic dermal thickness measurements

    between side differences of ultrasonographic dermal thickness measurements

    Time frame: Day 0

07

Study locations

1 site
  • Esra Giray
    Istanbul, 34899, Turkey
08

References and documents

Publications

  • Yang EJ, Kim SY, Lee WH, Lim JY, Lee J. Diagnostic Accuracy of Clinical Measures Considering Segmental Tissue Composition and Volume Changes of Breast Cancer-Related Lymphedema. Lymphat Res Biol. 2018 Aug;16(4):368-376. doi: 10.1089/lrb.2017.0047. Epub 2018 Jan 17. PubMed 29338541 ↗
  • Tassenoy A, De Strijcker D, Adriaenssens N, Lievens P. The Use of Noninvasive Imaging Techniques in the Assessment of Secondary Lymphedema Tissue Changes as Part of Staging Lymphedema. Lymphat Res Biol. 2016 Sep;14(3):127-33. doi: 10.1089/lrb.2016.0011. PubMed 27631582 ↗
  • Suehiro K, Morikage N, Yamashita O, Harada T, Samura M, Takeuchi Y, Mizoguchi T, Nakamura K, Hamano K. Skin and Subcutaneous Tissue Ultrasonography Features in Breast Cancer-Related Lymphedema. Ann Vasc Dis. 2016;9(4):312-316. doi: 10.3400/avd.oa.16-00086. Epub 2016 Nov 25. PubMed 28018504 ↗
  • Bok SK, Jeon Y, Hwang PS. Ultrasonographic Evaluation of the Effects of Progressive Resistive Exercise in Breast Cancer-Related Lymphedema. Lymphat Res Biol. 2016 Mar;14(1):18-24. doi: 10.1089/lrb.2015.0021. Epub 2016 Jan 29. PubMed 26824517 ↗
  • Han N, Cho Y, Hwang J, Kim H, Cho G. Usefulness of ultrasound examination in evaluation of breast cancer-related lymphedema. J Korean Acad Rehabil Med. 2011;35:101-9.

Individual participant data

Plan to share: No — The investigators don't plan to share IPD.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03676127
Lead sponsor
Marmara University
Responsible party
Sponsor
First posted
Sep 18, 2018
Start date
Sep 28, 2018
Primary completion
Dec 19, 2018
Completion
Dec 19, 2018
Last update
Dec 20, 2018

Study contacts

Esra Giray, MD
principal investigator · Marmara University

Oversight

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

Not currently enrolling

This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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