Clinical trial Recruiting at 1 site Interventional Ages 18 to 80 Women only

Predicting lymphedema risk in breast cancer patients

Official title: Intraoperative Nomogram to Predict Breast Cancer- Related Lymphedema Based in Artificial Intelligence Image Recognition: a Randomized Controlled Trial

Run by Wuhan University · NCT04665882 · Data updated 2026-11-12

This study is testing a new tool to help doctors predict which breast cancer patients are at risk for developing lymphedema after surgery so they can take steps to prevent it.

Quick facts

Study typeInterventional
Ages18 Years to 80 Years
SexWomen only
Enrollment600 (estimated)
SponsorWuhan University
Academic / other
Drugs / interventionschemotherapy
Locations1 site (Wuhan, Hubei)
StatusRecruiting
StartedDecember 11, 2020
Main results expectedDecember 31, 2022
Study endsDecember 31, 2027
Registry record updatedDecember 16, 2020
Trial IDNCT04665882 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include patients aged 18 years or older with invasive breast cancer who are clinically node-positive and have undergone specific surgical procedures.

Probably not a fit

Patients who have received neoadjuvant chemotherapy or have a previous history of breast cancer may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to develop a nomogram that predicts the risk of lymphedema in breast cancer patients who have undergone axillary lymph node dissection. It focuses on understanding the relationship between arm lymphatic drainage and the occurrence of lymphedema, particularly in patients with residual arm lymph nodes. By identifying high-risk individuals, the study allows for targeted intraoperative interventions to preserve arm lymphatics and potentially prevent lymphedema. The approach combines clinical assessments and surgical techniques to improve patient outcomes.

Why it matters

Potential benefit: If successful, this study could significantly reduce the incidence of lymphedema in breast cancer patients after surgery.

How similar studies have gone: While there have been studies on lymphedema prediction, this specific nomogram approach is novel and has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Patients aged 18 years or older with T1-3 invasive breast cancer;
* Clinically node-positive breast cancer, defined as positive on preoperative axillary palpation, ultrasound examination, and computed tomography scan with contrast;
* Patients who underwent mastectomy with a positive sentinel lymph node (SLN);
* Patients who underwent breast-conserving surgery containing more than two positive SLNs.

Exclusion Criteria:

* Neoadjuvant chemotherapy;
* Previous history of breast cancer.

Where it's running

  • Zhongnan Hospital of Wuhan University
    Wuhan, Hubei, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.