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 type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | Women only |
| Enrollment | 600 (estimated) |
| Sponsor | Wuhan University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Wuhan, Hubei) |
| Status | Recruiting |
| Started | December 11, 2020 |
| Main results expected | December 31, 2022 |
| Study ends | December 31, 2027 |
| Registry record updated | December 16, 2020 |
| Trial ID | NCT04665882 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
- Principal investigator: Gaosong Wu, Ph.D. — Wuhan University
- Study coordinator: Qianqian Yuan, M.D.
- Email: Yuanqq11@whu.edu.cn
- Phone: 13026322297
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.