NCT07252843已完成不适用
Lymphedema Prediction Model in Breast Cancer After Axillary Lymph Node Dissection: A Study of Clinicopathological Factors, Receptor Expression (VEGFR3, TGFBR2), and Genetic Predisposition (GJA4, MET, GATA2)
Dharmais National Cancer Center Hospital1 个研究点 分布在 1 个国家目标入组 133 人开始时间: 2022年10月11日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 133
- 试验地点
- 1
- 主要终点
- Occurrence of Arm Lymphedema
研究概览
简要总结
The goal of this observational ambidirectional cohort study is to develop a prediction model to identify the risk of lymphedema after axillary lymph node dissection (ALND) in patients with breast cancer. The main questions it aims to answer are:
- Can clinicopathological factors predict the development of lymphedema?
- Do protein expression profiles and genetic mutations increase susceptibility to lymphedema?
Participants will:
- Undergo clinical evaluation and indocyanine green (ICG) lymphography to diagnose lymphedema.
- Provide lymphatic tissue and blood samples during ALND surgery for immunohistochemical protein analysis and gene mutation assessment.
- Be followed over time to monitor the onset and progression of lymphedema.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Histopathologically confirmed breast cancer
- •Undergoing axillary lymph node dissection (ALND)
- •Able to undergo indocyanine green (ICG) lymphography examination
排除标准
- •Clinical signs of lymphedema prior to surgery, confirmed by clinical assessment and/or ICG lymphography
- •History of iodine allergy, asthma, impaired renal function, pregnancy, or breastfeeding
- •Incomplete clinical or laboratory data required for analysis
结局指标
主要结局
Occurrence of Arm Lymphedema
时间窗: Up to 24 months post-axillary lymph node dissection
Development of lymphedema identified through clinical signs and symptoms, confirmed using indocyanine green (ICG) lymphography. The presence or absence of lymphedema will be recorded during follow-up assessments.
次要结局
未报告次要终点
研究者
Rizky Ifandriani Putri
MD
Dharmais National Cancer Center Hospital
研究点 (1)
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