Diagnostic Accuracy of Dermal Thickness in Lymphedema

NCT03676127 | Completed

• 1 other identifier: 09.2018.
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lymphedema of Upper Arm; Breast Cancer

Keywords

assessment; breast cancer; diagnosis; lymphedema; measurement; ultrasound

Outcome Measures

Primary Outcomes (1)

• Area under curve

  Area under curve

  Day 0

Secondary Outcomes (4)

• Sensivity of between side differences of ultrasonographic dermal thickness measurements

  Day 0

• Specificity of between side differences of ultrasonographic dermal thickness measurements

  Day 0

• Interlimb volume difference

  Day 0

• between side differences of ultrasonographic dermal thickness measurements

  Day 0

Study Arms (1)

Study Group

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

Other: ultrasonographic dermal thickness measurements

Interventions

ultrasonographic dermal thickness measurements OTHER

ultrasonographic dermal thickness measurements

Study Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with breast cancer related lymphedema

You may qualify if:

• \. Patients with unilateral postmastectomy lymphedema

You may not qualify if:

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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Esra Giray

Istanbul, 34899, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 29338541 BACKGROUND

• 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.

  PMID: 27631582 BACKGROUND

• 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.

  PMID: 28018504 BACKGROUND

• 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.

  PMID: 26824517 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Disease; Lymphedema

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Esra Giray, MD

  Marmara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2018
• First Posted: September 18, 2018
• Study Start: September 28, 2018
• Primary Completion: December 19, 2018
• Study Completion: December 19, 2018
• Last Updated: December 20, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)