Stereotactic Directional Vacuum-Assisted Breast Biopsy

NCT01957020 | Completed

• 1 other identifier: 200806017R
• Study Type: observational
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief Summary

Stereotactic directional vacuum-assisted breast biopsy (ST DVAB) is a standard biopsy procedure for suspicious findings on mammograms in Western countries for more than 10 years \[1-3\], it has replaced the needle localization (NLOC) excisional biopsy for the lesions alike and was reported to feature a high sensitivity, very low delayed false-negative rate (less than 2%)\[4,5\]. Moreover, it causes less scarring, less psychologic stress to patients and less morbidity compared with needle localization excisional biopsy \[6,7\]. However, its sensitivity, accuracy has seldom been reported in Asian countries \[8\] , since most Asian women have different breast parenchyma pattern, different breast cancer prevalence. Therefore, we retrospectively reviewed outcomes of the two groups of patients receiving either ST DVAB or NLOC excisional biopsy, trying to investigate if ST DVAB can be an effective alternative to NLOC excisional biopsy in our country.

Conditions

Breast Cancer; Stereotactic Directional Vacuum-assisted Breast Biopsy; Female; Adult Patients

Outcome Measures

Primary Outcomes (1)

• The sensitivity of stereotactic vacuum assisted breast biopsy for breast cancer diagnosis

  the aforementioned outcome measure-"sensitivity"- is the probability of the stereotactic vaccum assisted breast biopsy can correctly diagnose the breast cancer. And according to statistical definition, it is defined as- for those breast cancer cases, how many of them can be correctly diagnosed by stereotactic breast biopsy.

  up to 5 years ( July 2008 to June 2013)

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

asymptomatic women with mammographic screening, and with suspicious findings on mammography.

You may qualify if:

• The indication for ST DVAB was lesions with suspicious nature for malignancy seen on mammograms which biopsy is necessitated for tissue proof, or probably benign or benign appearing lesions seen on mammograms but patients or clinicians requested biopsy

Sponsors & Collaborators

• National Taiwan University Hospital: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2013
• First Posted: October 8, 2013
• Study Start: June 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: January 1, 2009
• Last Updated: October 16, 2013

Record last verified: 2013-10