RecruitingNot ApplicableNCT04590560

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

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

Sponsor

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

Enrollment

60,000 participants

Start Date

Feb 6, 2020

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

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.

Eligibility

Sex: FEMALEMin Age: 45 YearsMax Age: 49 Years

Inclusion Criteria3

Women invited for their first or second mammography (45 or 46 y/o) presenting for screening;
Willingness and ability to comply with scheduled visits;
Written informed consent obtained prior to performing any protocol-related procedures.

Exclusion Criteria5

Pregnancy status;
Personal history of prior breast carcinoma, either invasive or ductal carcinoma in situ (DCIS) diagnosis;
Ascertained heredo-familial risk according to the standard family history used in screening programs;
Participation in another clinical trial on BC screening;
Inability to provide signed informed consent.

Interventions

DIAGNOSTIC_TESTscreening 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;