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

This study is currently recruiting participants.
Verified November 2011 by Yale University
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01452399
First received: September 29, 2011
Last updated: November 22, 2011
Last verified: November 2011
History of Changes

September 29, 2011
November 22, 2011
October 2011
September 2012   (final data collection date for primary outcome measure)
Optimal surgical treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01452399 on ClinicalTrials.gov Archive Site
  • Cosmesis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To determine the effect of routine shave margins on cosmesis
  • Operative time [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To determine the effect of routine shave margins on the time in the operating suite.
  • Volume of tissue resected [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To determine the effect of routine shave margins on the volume of tissue resected.
Same as current
Not Provided
Not Provided
 
A Randomized Controlled Trial of Routine Shave Margins Versus Standard Partial Mastectomy in Breast Cancer Patients
A Randomized Controlled Trial of Routine Shave Margins vs. Standard Partial Mastectomy in Breast Cancer Patients

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Procedure: Shave margins
    Partial mastectomy with shave margins.
  • Procedure: No Shave Margins
    Partial mastectomy without shave margins.
  • Experimental: Shave Margins
    Intervention: Procedure: Shave margins
  • Active Comparator: No shave margins
    Intervention: Procedure: No Shave Margins
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
January 2013
September 2012   (final data collection date for primary outcome measure)

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.
Female
18 Years to 90 Years
No
Contact: Anees Chagpar, M.D. 203-200-2328 anees.chagpar@yale.edu
United States
 
NCT01452399
1107008825
Yes
Yale University
Yale University
Not Provided
Not Provided
Yale University
November 2011

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