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

Plain Language Summary

Simplified for easier understanding

This trial is studying how often mammography screenings should be done for women in their mid-to-late 40s to most effectively detect breast cancer without unnecessary tests. You may be eligible if: you are a woman ages 45 or 46 attending your first or second mammogram screening; you are able to attend the required study visits; and you have provided written informed consent. You may NOT be eligible if: you are pregnant; you have a personal history of breast cancer (invasive or in situ); you have a family history suggesting high inherited risk; you are in another breast cancer screening trial; or you cannot provide informed consent. Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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;