Lymphedema Screening

Not Applicable

• Conditions: Lymphedema
• Interventions: Diagnostic Test: Circumference tape measurements; Diagnostic Test: Indocyanine green lymphangiography; Diagnostic Test: bioimpedance spectroscopy; Diagnostic Test: Symptom score

• Registration Number: NCT04606511
• Lead Sponsor: Odense University Hospital

Brief Summary

Breast cancer-related lymphedema is one of the most common and feared consequences of breast cancer treatment. Currently, there is no established screening program for lymphedema. This cross-sectional study will investigate diagnostic modalities in screening for lymphedema in patients with and without known lymphedema after breast cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-05
• Study First Submitted: 2020-10-08
• Study First Submitted QC: 2020-10-22
• Study First Posted: 2020-10-28
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-23
• Last Update Posted: 2021-02-24
• Primary Completion: 2021-10
• Study Completion: 2021-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Previous breast cancer treated with axillary lymph node dissection
• No recurrence
• Understand the study
• Can talk, read and understand Danish

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Exclusion Criteria

• Pregnant or breast feeding
• Lymph node dissection from other basins
• Psychiatric disorder
• Not possible to perform indocyanine green lymphangiography

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Breast cancer patients without lymphedema	Circumference tape measurements	-
Breast cancer patients without lymphedema	Symptom score	-
Breast cancer patients with lymphedema	Circumference tape measurements	-
Breast cancer patients with lymphedema	bioimpedance spectroscopy	-
Breast cancer patients with lymphedema	Indocyanine green lymphangiography	-
Breast cancer patients with lymphedema	Symptom score	-
Breast cancer patients without lymphedema	Indocyanine green lymphangiography	-
Breast cancer patients without lymphedema	bioimpedance spectroscopy	-

Primary Outcome Measures

Name	Time	Method
sensitivity, specificy, NPV and PPV	through study completion, approximately 1 year	diagnosotic statistics of lymphedema measurements

Trial Locations

Locations (1)

Department of Plastic and Reconstructive Surgery; 🇩🇰 Odense, Denmark