Clinical trial · Observational
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphedema Arm | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Occurrence of Arm Lymphedema
- timeFrame
- Up to 24 months post-axillary lymph node dissection
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available