Active — Not RecruitingNot Applicable

Tomosynthesis as Primary Test for Breast Cancer Screening

Italy10,156 participantsStarted 2019-03-01

Plain-language summary

Randomized trial comparing tomosynthesis plus synthetic 2D Mammography vs Digital Mammography in respect to incidence of advanced cancers (interval and following round) and interval cancers.

Who can participate

Age range

45 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Women scheduled for a new round of mammographic screening * resident in the province Exclusion Criteria: * previous breast cancer diagnosis * pregnancy or suspicion of pregnancy * presence of BRCA1/2 gene mutation * Previous Digital Breast Tomosynthesis performed * unable to understand informed consent * chemotherapy in progress * presence of breast implant

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

advanced cancer incidence

Timeframe: 2 years (+9 months to complete second round assessment)

advanced cancer incidence

Timeframe: 4 years (+9 months to complete third round assessment)

interval cancer incidence

Timeframe: 2 years for 50-65 years old women

interval cancer incidence

Timeframe: 1 year for 45-49 years old women

Trial details

NCT IDNCT04461808

SponsorAzienda USL Reggio Emilia - IRCCS

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2027-04-30

View on ClinicalTrials.gov More Breast Cancer trials

Who can participate

Age range

45 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

advanced cancer incidence

Timeframe: 2 years (+9 months to complete second round assessment)

advanced cancer incidence

Timeframe: 4 years (+9 months to complete third round assessment)

interval cancer incidence

Timeframe: 2 years for 50-65 years old women

interval cancer incidence

Timeframe: 1 year for 45-49 years old women