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

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-49
SponsorIstituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

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

Treatment groups

60,000 Participants
are divided into 3 treatment groups