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Brief Title: Shave Margins in Breast Conservation Therapy
Official Title: Shave Margins in Breast Conservation Therapy (SMART): A Randomized Controlled Trial
Study ID: NCT02462200
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Washington University School of Medicine, Saint Louis, Missouri, United States
Name: Julie Margenthaler, M.D.
Affiliation: Washington University School of Medicine
Role: PRINCIPAL_INVESTIGATOR