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New model aims to predict lymphedema risk in breast cancer patients

NCT ID NCT07252843

Knowledge-focused Sponsor: Dharmais National Cancer Center Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed study looked at 133 breast cancer patients to develop a way to predict who will get arm swelling (lymphedema) after lymph node removal surgery. Researchers examined patient characteristics, proteins, and genes to build a risk model. The goal is to help doctors identify high-risk patients early so they can take steps to prevent or manage lymphedema.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a tool that helps doctors identify which breast cancer patients are most likely to develop lymphedema after surgery, allowing for earlier monitoring or prevention.
What could go wrong
This is an observational study that only builds a prediction model; it does not test any treatment. The model may not be accurate enough for routine use and needs further validation in larger, more diverse groups.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

133 people

The number who actually took part.

Started

Oct 2022

Finished

Jul 2025

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population consists of adult patients diagnosed with breast cancer who are undergoing axillary lymph node dissection (ALND) as part of their standard surgical management. Eligible participants are recruited from Dharmais Cancer Hospital and Bogor City Regional General Hospital in Indonesia. Only patients without pre-existing lymphedema and who are able to undergo indocyanine green (ICG) lymphography are enrolled. Both early- and locally advanced breast cancer cases are included, provided clinical data and follow-up assessments can be completed.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm lymphedema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lymphedema arm

Contacts and locations

Locations

  • Dharmais Cancer Hospital

    Jakarta, DKI Jakarta, 11420, Indonesia

More trials for these conditions

Other studies related to the condition(s) this trial covers.