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A Randomized Controlled Trial of Routine Shave Margins Versus Standard Partial Mastectomy in Breast Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01452399
Recruitment Status : Active, not recruiting
First Posted : October 14, 2011
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Yale University

Tracking Information
First Submitted Date  ICMJE September 29, 2011
First Posted Date  ICMJE October 14, 2011
Last Update Posted Date January 27, 2020
Actual Study Start Date  ICMJE October 2011
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2011)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2011)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized Controlled Trial of Routine Shave Margins Versus Standard Partial Mastectomy in Breast Cancer Patients
Official Title  ICMJE A Randomized Controlled Trial of Routine Shave Margins vs. Standard Partial Mastectomy in Breast Cancer Patients
Brief Summary This research study is designed to look at whether the routine use of shave margins (by taking extra tissue at the time of partial mastectomy surgery) will reduce the chances of having positive surgical margins requiring another surgical procedure, and whether this affects the long-term chances of getting cancer back in your breast.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Procedure: Shave margins
    Partial mastectomy with shave margins.
  • Procedure: No Shave Margins
    Partial mastectomy without shave margins.
Study Arms  ICMJE
  • Experimental: Shave Margins
    Intervention: Procedure: Shave margins
  • Active Comparator: No shave margins
    Intervention: Procedure: No Shave Margins
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 24, 2015)
251
Original Estimated Enrollment  ICMJE
 (submitted: October 11, 2011)
250
Estimated Study Completion Date  ICMJE August 2020
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Breast cancer, stage 0-3, deemed a surgically appropriate candidate for partial mastectomy with planned procedure for the same.
  2. Women ≥ 18 years of age.
  3. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  1. Patients who have received previous neoadjuvant chemotherapy
  2. Patients who require a total mastectomy
  3. Known metastatic breast cancer.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01452399
Other Study ID Numbers  ICMJE 1107008825
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anees Chagpar, M.D. The Breast Center -- Smilow Cancer Hospital at Yale-New Haven
PRS Account Yale University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP