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Clinical Trials/NCT01166581
NCT01166581
Terminated
Not Applicable

Evaluation of Breast Magnetic Resonance Imaging (MRI) Impact on Mastectomy Rate at Summa Akron City Hospital

Summa Health System1 site in 1 country300 target enrollmentJuly 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Early Stage Breast Cancer
Sponsor
Summa Health System
Enrollment
300
Locations
1
Primary Endpoint
The primary goal of this study is to determine if preoperative breast MRI findings resulted in more extensive surgery than breast conserving surgery in early stage breast cancers at Summa Akron City Hospital.
Status
Terminated
Last Updated
11 years ago

Overview

Brief Summary

The primary goal of this study is to determine if preoperative breast MRI findings resulted in more extensive surgery, i.e., mastectomy than breast conserving surgery, i.e., lumpectomy in early stage breast cancers at Summa Akron City Hospital. Early stage breast cancer is defined as breast tumor size less than 5 cm.

The objectives are to:

  • Review early stage breast cancer patient cases treated at Summa Akron City Hospital between 2006 and 2009 to evaluate clinical and pathological staging
  • Determine the results of preoperative breast MRI and the impact on type of surgery performed
  • Evaluate the decision to have mastectomy rather than lumpectomy, i.e., physician or patient decision and if this decision was based on breast MRI findings

Detailed Description

Early stage breast cancer cases between 2006 and 2009 will be identified by the Summa Akron City Hospital cancer registry. The cases will be reviewed and abstracted. The abstracted data will include results of physical breast examinations, mammograms, sonograms, breast MRI reports, biopsy procedure notes and pathology reports to illustrate the clinical stage. Definitive surgical pathology reports will be included in the abstracted data to demonstrate the final pathologic stage of the breast cancer. A database will be developed to capture the abstracted data. Outcomes will be determined based on final pathology reports.

Registry
clinicaltrials.gov
Start Date
July 2010
End Date
January 2015
Last Updated
11 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • early stage breast cancer between 2006-2009
  • preoperative MRI

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

The primary goal of this study is to determine if preoperative breast MRI findings resulted in more extensive surgery than breast conserving surgery in early stage breast cancers at Summa Akron City Hospital.

Time Frame: from 2006-2009

Review early stage breast cancer patient cases treated at Summa Akron City Hospital between 2006 and 2009 to evaluate clinical and pathological staging Determine the results of preoperative breast MRI and the impact on type of surgery performed Correlate the breast MRI findings with the final pathology results to determine if the breast MRI clinically upstaged the cancer.

Secondary Outcomes

  • Correlate the breast MRI findings with the final pathology results to determine if the breast MRI clinically upstaged the cancer(2006-2009)

Study Sites (1)

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