A Randomized Controlled Trial of Routine Shave Margins Versus Standard Partial Mastectomy in Breast Cancer Patients
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|ClinicalTrials.gov Identifier: NCT01452399|
Recruitment Status : Active, not recruiting
First Posted : October 14, 2011
Last Update Posted : January 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Procedure: Shave margins Procedure: No Shave Margins||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||251 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Trial of Routine Shave Margins vs. Standard Partial Mastectomy in Breast Cancer Patients|
|Actual Study Start Date :||October 2011|
|Actual Primary Completion Date :||August 2014|
|Estimated Study Completion Date :||August 2020|
|Experimental: Shave Margins||
Procedure: Shave margins
Partial mastectomy with shave margins.
|Active Comparator: No shave margins||
Procedure: No Shave Margins
Partial mastectomy without shave margins.
- Optimal surgical treatment [ Time Frame: 12 months ]To determine whether routine shave margins in breast cancer patients undergoing partial mastectomy will result in more optimal surgical treatment of breast cancer patients, as defined by reduced positive margin rates
- Cosmesis [ Time Frame: 12 months ]To determine the effect of routine shave margins on cosmesis
- Operative time [ Time Frame: 12 months ]To determine the effect of routine shave margins on the time in the operating suite.
- Volume of tissue resected [ Time Frame: 12 months ]To determine the effect of routine shave margins on the volume of tissue resected.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01452399
|United States, Connecticut|
|Yale University School of Medicine|
|New Haven, Connecticut, United States, 06510|
|Principal Investigator:||Anees Chagpar, M.D.||The Breast Center -- Smilow Cancer Hospital at Yale-New Haven|