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NCT02462200 · ClinicalTrials.gov registry record · Phase 2
Shave Margins in Breast Conservation Therapy
A Phase 2 study, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- Phase 2
- Development phase
- 81
- Enrollment target
NCT02462200 is a Phase 2 study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 81 participants.
The verdict
NCT02462200, a Phase 2 study, was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 81 participants
- Enrollment target
Study Summary
The investigators propose a randomized controlled superiority trial of standard breast-conserving surgery (BCS) versus BCS with cavity shave margins (CSM). The main objectives of this trial will be to evaluate prospectively the impact of routine standardized CSM on margin status following primary surgery for early stage breast cancer (Stage 0 - II), on post-operative patient satisfaction and cosmetic outcomes, and on general intraoperative time and operative costs. A parallel group format will be implemented to compare this modified surgical therapy - BCS with CSM - with BCS alone, which is the current standard of care.
Interventions
- PROCEDURE Breast-conserving surgery (BCS)
- PROCEDURE Cavity shave margins (CSM)
- BEHAVIORAL BREAST-Q Questionnaire
- DEVICE 3-D breast imaging
- OTHER Indocyanine green
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2016-06-13 |
| Est. Completion | 2019-11-27 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02462200
The ClinicalTrials.gov registry entry for NCT02462200 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Breast-conserving surgery (BCS) is the first listed.
NCT02462200 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02462200 about?
NCT02462200 is a clinical study titled "Shave Margins in Breast Conservation Therapy". The investigators propose a randomized controlled superiority trial of standard breast-conserving surgery (BCS) versus BCS with cavity shave margins (CSM). The main objectives of this trial will be to evaluate prospectively the impact of routine standardized CSM on margin status following primary su...
What is the current status of trial NCT02462200?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 81 participants. The study started on 2016-06-13. Estimated completion is 2019-11-27.
What interventions are being tested in trial NCT02462200?
The interventions under investigation include: Breast-conserving surgery (BCS) (PROCEDURE), Cavity shave margins (CSM) (PROCEDURE), BREAST-Q Questionnaire (BEHAVIORAL), 3-D breast imaging (DEVICE), Indocyanine green (OTHER).
Who is sponsoring clinical trial NCT02462200?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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