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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04926688

Enrollment

1345

Registered

2021-06-15

Start date

2020-06-10

Completion date

2021-06-10

Last updated

2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premalignant Lesion

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Inclusion criteria

Study Population: The women with diagnosis of atypical ductal hyperplasia, lobular neoplasia, flat epithelial atypia, papilloma and radial scar on image guided core needle biopsy were studied Sampling Method: Non-Probability Sample Minimum Age: 12 Maximum Age: 86 Sex: Female Gender Based: No Accepts Healthy Volunteers: No Criteria: 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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Turkey (Türkiye)

Outcome results