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

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.

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Key information

Conditions

Lymphedema Arm Breast Diseases Breast Neoplasms Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dharmais Cancer Hospital

Jakarta, DKI Jakarta, 11420, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Occurrence of Arm Lymphedema

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Dharmais National Cancer Center Hospital

Other Gov

Collaborators

Fakultas Kedokteran Universitas Indonesia

Registry information

Official study title

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)

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2025
First posted: Nov 28, 2025
Registry last updated: Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed