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Clinical Trials/NCT01166581
NCT01166581TerminatedNot 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 enrollmentStarted: July 2010Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
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.

Study 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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