Integrating Clinical, Protein Expression, and Genetic Markers to Predict Lymphedema in Breast Cancer

Dharmais National Cancer Center Hospital

Status: Completed

Conditions: Lymphedema Arm

Study type: Observational

Funder types: Other

Identifiers

NCT07252843

308/KEPK/IX/2023

Details and patient eligibility

About

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.

Enrollment: 133 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years
• Histopathologically confirmed breast cancer
• Undergoing axillary lymph node dissection (ALND)
• Able to undergo indocyanine green (ICG) lymphography examination

Exclusion criteria

• 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