Lymphedema Screening

Overview

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.

Full Title of Study: “Screening for Lymphedema”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2021

Interventions

  • Diagnostic Test: Circumference tape measurements
    • centimeter and volume criterias
  • Diagnostic Test: Indocyanine green lymphangiography
    • Presence of dermal backflow
  • Diagnostic Test: bioimpedance spectroscopy
    • 7.5 and 10 L-DEX criterias
  • Diagnostic Test: Symptom score
    • using lymph-icf, DASH and SF-36 questionnaires

Arms, Groups and Cohorts

  • Other: Breast cancer patients with lymphedema
  • Other: Breast cancer patients without lymphedema

Clinical Trial Outcome Measures

Primary Measures

  • sensitivity, specificy, NPV and PPV
    • Time Frame: through study completion, approximately 1 year
    • diagnosotic statistics of lymphedema measurements

Participating in This Clinical Trial

Inclusion Criteria

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

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Odense University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mads Gustaf Jørgensen, Principal Investigator – Odense University Hospital
  • Overall Contact(s)
    • Mads G Jørgensen, MD, 29210114, Mads.Gustaf.Jorgensen@rsyd.dk

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