High-risk Breast Lesions: A Multicenter Retrospective Study

Completed

• Conditions: Premalignant Lesion

• Registration Number: NCT04926688
• Lead Sponsor: Ege University

Brief 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.

Study Timeline

• Study Start: 2020-06-10
• Primary Completion: 2021-01-20
• Study Completion: 2021-06-10
• Study First Submitted: 2021-06-10
• Study First Submitted QC: 2021-06-10
• Study First Posted: 2021-06-15
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-26
• Last Update Posted: 2022-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1345

Inclusion Criteria

• Image guided needle biopsy diagnosis
• Atypical ductal hyperplasia
• Lobular neoplasia
• Flat epithelial atypia
• Papilloma
• Radial scar
• Diagnosed on image guided needle biopsy

Exclusion Criteria

• Fibroepithelial tumors
• Mucocele like tumors
• Diagnosed on surgical biopsy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
upgrade rates related to histologic subtype, tissue sampling and other variables	one year	the results from excisional biopsy or at least 1 year follow-up documentation

Trial Locations

Locations (1)

Ege University; 🇹🇷 İzmir, Turkey