High-risk Breast Lesions: A Multicenter Retrospective Study

Premalignant Lesion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04926688
• Other study ID #: 20-6T/41
• Status: Completed
• Start date: June 10, 2020
• Est. completion date: June 10, 2021

Study information

• Verified date: April 2022
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1345
• Est. completion date: June 10, 2021
• Est. primary completion date: January 20, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Precancerous Conditions
• Premalignant Lesion

Locations

Country	Name	City	State
Turkey	Ege University	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	upgrade rates related to histologic subtype, tissue sampling and other variables	the results from excisional biopsy or at least 1 year follow-up documentation	one year