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NCT00932035 · ClinicalTrials.gov registry record · Phase 1
Axillary Lymph Node Preservation Surgery in Reducing Lymphedema in Patients With Breast Cancer
A Phase 1 study, sponsored by City of Hope Medical Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
NCT00932035: Clinical Trial Phase 1 study, sponsored by City of Hope Medical Center.
NCT00932035 is a Phase 1 study that was terminated before completion, run by City of Hope Medical Center. The registered enrollment target is 39 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00932035, a Phase 1 study, was terminated before completion, sponsored by City of Hope Medical Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
Study Summary
This pilot phase I and randomized phase II trial studies the best way to perform axillary lymph node preservation surgery and to see how well it works in preventing lymphedema in patients with breast cancer. Lymph node mapping may help in planning surgery to remove breast cancer and affected lymph nodes. It is not yet known whether reverse mapping guided axillary lymph node dissection is more effective than standard axillary lymph node dissection in preventing lymphedema.
Primary Outcome
A Fisher's exact test with a one-sided alpha of 0.05 will be used to determine if the percentage of patients with arm lymphatics above, around, or below the axillary vein in the standard dissection group is superior to the experimental dissection group.
Interventions
- PROCEDURE quality-of-life assessment
- OTHER Questionnaire administration
- PROCEDURE axillary lymph node dissection
- DRUG isosulfan blue based lymphatic mapping
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2009-06 |
| Est. Completion | 2014-05 |
| Phase | Phase 1 |
Why NCT00932035 stopped before completion
NCT00932035 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 4 interventions - of which quality-of-life assessment is the first listed.
NCT00932035 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00932035 about?
NCT00932035 is a clinical study titled "Axillary Lymph Node Preservation Surgery in Reducing Lymphedema in Patients With Breast Cancer". This pilot phase I and randomized phase II trial studies the best way to perform axillary lymph node preservation surgery and to see how well it works in preventing lymphedema in patients with breast cancer. Lymph node mapping may help in planning surgery to remove breast cancer and affected lymph n...
What is the current status of trial NCT00932035?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2009-06. Estimated completion is 2014-05.
What interventions are being tested in trial NCT00932035?
The interventions under investigation include: quality-of-life assessment (PROCEDURE), Questionnaire administration (OTHER), axillary lymph node dissection (PROCEDURE), isosulfan blue based lymphatic mapping (DRUG).
Who is sponsoring clinical trial NCT00932035?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00932035's enrollment target sits among peer trials
39 1191st of 2000 higher than 804 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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