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Risk-Based Breast Screening in Young Women

NCT05675085 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10269

Last updated 2023-10-12

No results posted yet for this study

Summary

The RIBBS study is a single-arm single-center study that aims to evaluate the effectiveness of a risk-based breast screening model using digital breast tomosynthesis (DBT) as the baseline test, quantitative individual breast density to guide supplemental ultrasound (US) imaging for dense breasts, and individual risk (calculated taking into account breast density) to guide the screening interval (annual or biennial).

Invited 45-year-old women are differentiated into five different screening protocols (based on breast density and risk), and screened according to a personalized model until they turn 50 and return to routine screening.

The only primary endpoint in this study is the cumulative incidence of advanced breast cancers (stage II and above). This endpoint will be evaluated at the end of the five-year intervention period and at 10 years.

The results of the personalized screening model will be compared with those obtained from an observational cohort from a neighboring region in which a "one-size-fits-all" approach involving annual mammography for women aged 45-49 years is used. The comparison will be conducted with the hypothesis of superiority of the personalized screening model.

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.

Sponsors & Collaborators

  • Regione del Veneto (Italy)

    collaborator UNKNOWN

  • Istituto Oncologico Veneto IRCCS

    lead OTHER

Principal Investigators

  • Francesca Caumo, MD · Istituto Oncologico Veneto IRCCS

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-20
Primary Completion
2021-12-21
Completion
2026-01-31

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05675085 on ClinicalTrials.gov