Breast Cancer Clinical Trial
Official title:
Diagnostic Accuracy of Between Side Differences of Ultrasonographic Dermal Thickness Measurements in Breast Cancer Related Arm Lymphedema
Verified date | December 2018 |
Source | Marmara University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 43 |
Est. completion date | December 19, 2018 |
Est. primary completion date | December 19, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. Patients with unilateral postmastectomy lymphedema 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Esra Giray | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Marmara University |
Turkey,
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. — View Citation
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.
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. — View Citation
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. Review. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Area under curve | Area under curve | Day 0 | |
Secondary | Sensivity of between side differences of ultrasonographic dermal thickness measurements | Sensivity of between side differences of ultrasonographic dermal thickness measurements | Day 0 | |
Secondary | Specificity of between side differences of ultrasonographic dermal thickness measurements | Specificity of between side differences of ultrasonographic dermal thickness measurements | Day 0 | |
Secondary | Interlimb volume difference | Interlimb volume differencedetected via truncated cone method from circumference measurements | Day 0 | |
Secondary | between side differences of ultrasonographic dermal thickness measurements | between side differences of ultrasonographic dermal thickness measurements | Day 0 |
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