CompletedNot Applicable

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

Indonesia133 participantsStarted 2022-10-11

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Occurrence of Arm Lymphedema

Timeframe: Up to 24 months post-axillary lymph node dissection

Trial details

NCT IDNCT07252843

SponsorDharmais National Cancer Center Hospital

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2024-03-21

View on ClinicalTrials.gov More Lymphedema Arm trials