NCT04665882 Nomogram to Predict Breast Cancer Related Lymphedema
| NCT ID | NCT04665882 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wuhan University |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2020-12-11 |
| Primary Completion | 2022-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 600 participants in total. It began in 2020-12-11 with a primary completion date of 2022-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
It has been hypothesized that damaged arm lymphatic drainage is associated with the arm lymphedema after axillary lymph node dissection (ALND). However, the majority of breast cancer patients with complete ALND has not suffered from arm lymphedema, which appears to be due to the residual arm lymph nodes that has not been removed in the axillary dissection. With the compensation of the residual arm lymph flow above the level of axillary vein, the arm lymphatic drainage could keep balance and remain normal function. This arm lymphedema prediction model that included the protective factor, the proportion of arm lymph flow above the level of axillary vein, allows intraoperative intervention to be performed for the high-risk group. The arm lymphatics of these distinguished patients would be preserved to eliminate the occurrence of arm lymphedema in this study.
Eligibility 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.
Contact & Investigator
Gaosong Wu, Ph.D.
PRINCIPAL INVESTIGATOR
Wuhan University
Frequently Asked Questions
Who can join the NCT04665882 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 80 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04665882 currently recruiting?
Yes, NCT04665882 is actively recruiting participants. Contact the research team at Yuanqq11@whu.edu.cn for enrollment information.
Where is the NCT04665882 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT04665882 clinical trial?
NCT04665882 is sponsored by Wuhan University. The principal investigator is Gaosong Wu, Ph.D. at Wuhan University. The trial plans to enroll 600 participants.
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