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What is the Best Interval to Screen Women 45-49 and 70-74 for Breast Cancer?

NCT04590560 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60000

Last updated 2024-12-09

No results posted yet for this study

Summary

Italian, multicenter, study aimed at defining the best interval for screening women 45-49 and 70-74 years for Breast Cancer (BC). This research project includes (1) a controlled, prospective randomized non-inferiority trial to determine the optimal screening interval for women aged 45-49, with and without high mammographic density, (2) a retrospective data collection, with the same purpose, on screening performed by women aged 70-74, and (3) a qualitative research to define the best communication strategy.

Conditions

Interventions

DIAGNOSTIC_TEST

screening for breast cancer with tomosynthesis and synthetic 2D mammography performed at different interval compared to actual clinical practice

women will be screened for breast cancer using tomosynthesis and synthetic 2D mammography with an interval defined according to their randomization arm for a follow-up period of 6 years;

Sponsors & Collaborators

  • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

    lead OTHER

Principal Investigators

  • Fabio Falcini, MD · IRST IRCCS

  • Livia Giordano, MD · A.O.U. Città della Salute e della Scienza

  • Marco Zappa, MD · ISPRO Firenze

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-06
Primary Completion
2026-02-28
Completion
2026-02-28

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

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 NCT04590560 on ClinicalTrials.gov