Screening for Lymphedema
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- sensitivity, specificy, NPV and PPV
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previous breast cancer treated with axillary lymph node dissection
- •No recurrence
- •Understand the study
- •Can talk, read and understand Danish
排除标准
- •Pregnant or breast feeding
- •Lymph node dissection from other basins
- •Psychiatric disorder
- •Not possible to perform indocyanine green lymphangiography
研究组 & 干预措施
Breast cancer patients without lymphedema
干预措施: Indocyanine green lymphangiography (Diagnostic Test)
Breast cancer patients without lymphedema
干预措施: bioimpedance spectroscopy (Diagnostic Test)
Breast cancer patients without lymphedema
干预措施: Symptom score (Diagnostic Test)
Breast cancer patients with lymphedema
干预措施: Circumference tape measurements (Diagnostic Test)
Breast cancer patients with lymphedema
干预措施: Indocyanine green lymphangiography (Diagnostic Test)
Breast cancer patients with lymphedema
干预措施: bioimpedance spectroscopy (Diagnostic Test)
Breast cancer patients with lymphedema
干预措施: Symptom score (Diagnostic Test)
Breast cancer patients without lymphedema
干预措施: Circumference tape measurements (Diagnostic Test)
结局指标
主要结局
sensitivity, specificy, NPV and PPV
时间窗: through study completion, approximately 1 year
diagnosotic statistics of lymphedema measurements
次要结局
未报告次要终点
研究者
Mads Gustaf Jørgensen
Principal Investigator
Odense University Hospital