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

NCT07252843 | Completed

• 1 other identifier: 308/KEPK/IX/2023
• Study Type: observational
• Target: 133
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphedema Arm

Keywords

breast cancer; lymphedema; prediction model

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 24 months post-axillary lymph node dissection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Age ≥ 18 years
• Histopathologically confirmed breast cancer
• Undergoing axillary lymph node dissection (ALND)
• Able to undergo indocyanine green (ICG) lymphography examination

You may not qualify if:

• 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

Sponsors & Collaborators

• Dharmais National Cancer Center Hospital: lead
• Fakultas Kedokteran Universitas Indonesia: collaborator

Study Sites (1)

Dharmais Cancer Hospital

Jakarta, DKI Jakarta, 11420, Indonesia

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA from blood samples FFPE of lymphatic tissues

MeSH Terms

Conditions

Breast Neoplasms; Lymphedema

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Rizky Ifandriani Putri, MD

  Anatomical Pathology Department, Dharmais Cancer Hospital - National Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 12 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 28, 2025
• Study Start: October 11, 2022
• Primary Completion: March 21, 2024
• Study Completion: July 29, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

ID (1)