Predicting lymphedema risk in breast cancer patients
Intraoperative Nomogram to Predict Breast Cancer- Related Lymphedema Based in Artificial Intelligence Image Recognition: a Randomized Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Wuhan University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT04665882 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who have received neoadjuvant chemotherapy or have a previous history of breast cancer may not benefit from this study.
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 performed: While there have been studies on lymphedema prediction, this specific nomogram approach is novel and has not been extensively tested.
Eligibility criteria
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 this trial is running
Wuhan, Hubei
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.