Risk-Based Breast Screening in Young Women

NAActive, not recruitingINTERVENTIONAL
Enrollment

10,269

Participants

Timeline

Start Date

January 20, 2020

Primary Completion Date

December 21, 2021

Study Completion Date

January 31, 2026

Conditions
Breast Neoplasms
Interventions
DIAGNOSTIC_TEST

Personalized screening protocol

"At the first screening round (recruitment) all participating women had the same tests;~* Two-view tomosynthesis of both breasts~* Calculation of volumetric breast density (VBD)~* Calculation of lifetime risk (LTR) using the Tyrer-Cuzick model~At subsequent rounds:~1. Women with non-dense breasts and low breast cancer risk are re-screened only with DBT every 2 years;~2. Women with dense breasts and low breast cancer risk are re-screened with DBT+US every 2 years;~3. Women with non-dense breasts and intermediate breast cancer risk are re-screened only with DBT every year;~4. Women with dense breasts and intermediate breast cancer risk are re-screened with DBT+US every year;~5. Women at high risk of breast cancer associated with a family history of breast cancer (w/wo hereditary factors) undergo DBT and MRI every year."

Trial Locations (1)

35128

Istituto Oncologico Veneto (IRCCS), Padua

All Listed Sponsors
collaborator

Regione del Veneto (Italy)

UNKNOWN

lead

Istituto Oncologico Veneto IRCCS

OTHER

NCT05675085 - Risk-Based Breast Screening in Young Women | Biotech Hunter | Biotech Hunter