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NCT07127003 · ClinicalTrials.gov registry record · NA
ILR to Prevent BRCL_MCC 23608
A NA study, sponsored by University of South Florida.
- Recruiting
- Registry status
- NA
- Development phase
- 98
- Enrollment target
NCT07127003: Recruiting NA study, sponsored by University of South Florida.
NCT07127003 is a NA study that is actively recruiting participants, run by University of South Florida. The registered enrollment target is 98 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07127003, a NA study, is actively recruiting participants, sponsored by University of South Florida.
- RECRUITING
- Registry status
- NA
- Development phase
- 98 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to evaluate the effectiveness of Immediate Lymphatic Reconstruction (ILR) in preventing breast cancer-related lymphedema (BCRL) in high-risk patients. It will also assess the safety and quality of life outcomes associated with the procedure. The main questions it aims to answer are: Does ILR reduce the incidence of BCRL in patients undergoing axillary lymph node dissection (ALND)? What are the patient-reported outcomes and quality of life differences between those who receive ILR and those who do not? Participants will be identified as high-risk for developing BCRL through a multidisciplinary tumor board and referred to a specialized clinic for further evaluation. High-risk patients will undergo a series of screening tests, including bioimpedance spectroscopy (BIS), circumferential limb measurements, and infrared 3D perometry. Participants will be randomly assigned to one of two groups: Intervention Group (Study Arm A): Undergo ILR during ALND surgery, where preserved lymphatic channels are connected to nearby veins to prevent lymphedema. Control Group (Study Arm B): Will not receive ILR, but efforts will be made to preserve lymphatic channels during surgery. Patients will be blinded to their group assignment. Post-surgery, all participants will receive education from a certified lymphatic physical therapist. At the 2-week postoperative visit, participants will be further randomized into two postoperative monitoring protocols: BCRL Clinical Pathway: Patients will have regular follow-up visits every three months for two years, including repeat BIS, limb measurements, perometry, and quality of life questionnaires (LYMQOL and ULL-27). Standard of Care: Patients will be monitored only if they experience BCRL symptoms or after two years from ALND. The study will compare the outcomes of both groups, with a focus on the incidence of BCRL and patient quality of life, and will benchmark these results against published literature
Primary Outcome
Efficacy of ILR will be measured by the incidence of BCRL at the 24 month post follow up visit
Interventions
- PROCEDURE Immediate Lymphatic Reconstruction
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2025-10-01 |
| Est. Completion | 2027-10-01 |
| Phase | NA |
What NCT07127003 shows while recruiting
NCT07127003 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Immediate Lymphatic Reconstruction is the first listed.
NCT07127003 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07127003 about?
NCT07127003 is a clinical study titled "ILR to Prevent BRCL_MCC 23608". The goal of this clinical trial is to evaluate the effectiveness of Immediate Lymphatic Reconstruction (ILR) in preventing breast cancer-related lymphedema (BCRL) in high-risk patients. It will also assess the safety and quality of life outcomes associated with the procedure. The main questions it a...
What is the current status of trial NCT07127003?
This trial is currently recruiting. It is a NA study. The enrollment target is 98 participants. The study started on 2025-10-01. Estimated completion is 2027-10-01.
What interventions are being tested in trial NCT07127003?
The interventions under investigation include: Immediate Lymphatic Reconstruction (PROCEDURE).
Who is sponsoring clinical trial NCT07127003?
This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07127003's enrollment target sits among peer trials
98 922nd of 2000 higher than 1,078 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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