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

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)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07252843
Enrollment
133
Registered
2025-11-28
Start date
2022-10-11
Completion date
2025-07-29
Last updated
2025-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphedema Arm

Keywords

breast cancer, lymphedema, prediction model

Brief summary

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.

Interventions

None listed

Sponsors

Fakultas Kedokteran Universitas Indonesia
CollaboratorOTHER
Dharmais National Cancer Center Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Occurrence of Arm LymphedemaUp to 24 months post-axillary lymph node dissectionDevelopment 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.

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026