Lymphedema ArmNCT07252843
Integrating Clinical, Protein Expression, and Genetic Markers to Predict Lymphedema in Breast Cancer
An observational study of Lymphedema Arm, run by Dharmais National Cancer Center Hospital at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphedema Arm
- How many people
- 133 participants
- Where
- 1 siteIndonesia
- Study dates
- 11 Oct 2022to 29 Jul 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Age ≥ 18 years
- Histopathologically confirmed breast cancer
- Undergoing axillary lymph node dissection (ALND)
- Able to undergo indocyanine green (ICG) lymphography examination
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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)
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?
Read more
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
- Lymphedema Arm
- Keywords
- breast cancer, lymphedema, prediction model
- Medical subject headings
- Breast Neoplasms, Lymphedema
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Arm Lymphedema
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.
Measured: Up to 24 months post-axillary lymph node dissection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start11 Oct 2022
- Primary completion21 Mar 2024
- Study completion29 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphedema ArmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 133 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Dharmais National Cancer Center Hospital
- Sponsor type
- Other government
- Collaborators
- Fakultas Kedokteran Universitas Indonesia
- Responsible party
- Principal investigator, Rizky Ifandriani Putri, Dharmais National Cancer Center Hospital
- Investigators
- Rizky Ifandriani Putri, MD, Principal investigator, Anatomical Pathology Department, Dharmais Cancer Hospital - National Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252843
- Sponsor's protocol ID
- 308/KEPK/IX/2023
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The datasets analyzed during the current study are available from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07252843
- Acronym / sponsor ID
- 308/KEPK/IX/2023
- Conditions
- Lymphedema Arm
- Keywords
- breast cancer, lymphedema, prediction model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Dharmais National Cancer Center HospitalOther government
- Collaborators
- Fakultas Kedokteran Universitas Indonesia
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- 21 Mar 2024 (actual)
- Study completion
- 29 Jul 2025 (actual)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Histopathologically confirmed breast cancer
- Undergoing axillary lymph node dissection (ALND)
- Able to undergo indocyanine green (ICG) lymphography examination
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: Undecided. The datasets analyzed during the current study are available from the corresponding author upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rizky Ifandriani Putri, MD principal investigator
Anatomical Pathology Department, Dharmais Cancer Hospital - National Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphedema Arm, run by Dharmais National Cancer Center Hospital at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Arm Lymphedema (time frame: Up to 24 months post-axillary lymph node dissection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.