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Completed

NCT Number: NCT04926688

High-risk Breast Lesions: A Multicenter Retrospective Study

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.

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Key information

Conditions

Premalignant Lesion

Sex eligibility

Female

Study type

Observational

Primary location

Ege University

Izmir, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. upgrade rates related to histologic subtype, tissue sampling and other variables

    Time frame: one year

    the results from excisional biopsy or at least 1 year follow-up documentation

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 15, 2021
Registry last updated
May 2, 2022

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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