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Completed

NCT Number: NCT01957020

Stereotactic Directional Vacuum-Assisted Breast Biopsy

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.

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Key information

Conditions

Breast Cancer Adult Patients Breast Diseases Breast Neoplasms Female Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Stereotactic Directional Vacuum-assisted Breast Biopsy

Age range

30 year–80 year

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

-

Treatment and study plan

Primary outcomes

  1. The sensitivity of stereotactic vacuum assisted breast biopsy for breast cancer diagnosis

    Time frame: up to 5 years ( July 2008 to June 2013)

    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.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

The Diagnostic Accuracy of Stereotactic Directional Vacuum-Assisted Breast Biopsy

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Oct 8, 2013
Registry last updated
Oct 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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