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NCT04259866 Clinical Trial

FALSE POSITIVE FINDINGS IN BREAST CANCER TOMOSYNTHESIS

Breast Cancer Screening Clinical Trial

Official title:
FALSE POSITIVE FINDINGS IN BREAST CANCER TOMOSYNTHESIS: An Analysis of Findings Leading to Recall and Work-up in ASL Avellino Screening

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04259866
Other study ID # 05022020
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date January 1, 2020

Study information
Verified date February 2020
Source "G Criscuoli" Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To analyse false positives in breast cancer screening with tomosynthesis versus 2D mammography. The Avellino Breast Tomosynthesis Screening Trial is a observational population-based study that analyze souspicious findings in tomosynthesis slice images.

This study is based on two years screening and tomosynthesis was analzyed by two expert breast radiologists.

Recruitment information / eligibility
Status Completed
Enrollment 4500
Est. completion date January 1, 2020
Est. primary completion date January 1, 2020
Accepts healthy volunteers
Gender Female
Age group 50 Years to 69 Years
Eligibility Inclusion Criteria:

- breast cancer screening population

Exclusion Criteria:

- previous cancer

- breast prostheses

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy Graziella Di Grezia Avellino Av

Sponsors (1)
Lead Sponsor Collaborator
"G Criscuoli" Hospital

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary recall rate 15 days
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