NCT04926688

High-risk Breast Lesions: A Multicenter Retrospective Study

Outcome of High-risk Breast Lesions Diagnosed on Image-guided Core Needle Biopsy: Results From a Multicenter Retrospective Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,345 (actual)
• Sponsor: Ege University · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

In this multicenter study, the goal was to document the excisional biopsy or follow-up results of high risk lesions diagnosed on image guided CNB/VAB, and evaluate the clinical, imaging and histologic features for associated malignancy risk. The possibility of upgrade related to histologic subtype, tissue sampling and other variables was also evaluated.

Detailed description

This is a retrospective multicentric study that include 1345 patients from 30 centers. Patients who had a diagnosis of high risk lesions (HRL) on image guided core biopsy (tru-cut/vacuum biopsy) were reviewed in a 12 year period (between 2008 and 2020). The lesions included were ADH, LN (ALH/LCIS), papilloma (without or with atypia), RS, and FEA. The patients who managed with an excisional biopsy or having at least 1 year follow-up documentation following the diagnosis of borderline lesion were included in the study. Radiological findings, diameter of lesion (\>15 vs \<15 mm), needle biopsy type (14-16G vs 9-12G), sampling method and number of samplings (4 and \>4 vs \<4) were documented. IBM SPSS Version 25.0 statistical package program was used for analysis.

Conditions

• Premalignant Lesion

Timeline

• Start date: 2020-06-10
• Primary completion: 2021-01-20
• Completion: 2021-06-10
• First posted: 2021-06-15
• Last updated: 2022-05-02

Locations

1 site across 1 country: Turkey (Türkiye)