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Could your genes decide when you get a mammogram? major study tests personalized breast cancer screening

NCT ID NCT03672331

Prevention Sponsor: UNICANCER Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 23, 2026 · Updated 2 times

Summary

This study is testing whether a breast cancer screening plan based on each woman's personal risk (using clinical factors and genetic markers) works better than the standard schedule. Over 53,000 women aged 40-70 are being randomly assigned to either risk-based or standard screening for 4 years. The goal is to see if the personalized approach reduces the number of advanced (stage 2 or higher) breast cancers detected.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could show that tailoring screening to a woman's personal risk is better than a one-size-fits-all approach, potentially reducing advanced breast cancers.
What could go wrong
This is a large study, but results are not yet available. The personalized strategy may not prove superior, and risk assessment tools may not be accurate for all women.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

53,142 people

The number who actually took part.

Started

Jul 2019

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 70 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Female (whether born female or not) 2. Aged 40 to 70 years old (inclusive) 3. Willing and able to comply with scheduled visits, laboratory tests, and other trial procedures 4. Able to provide written informed consent obtained prior to performing any protocol-related procedures 5. Sufficient understanding of any of the languages used in the study 6. Affiliated to a social security/national healthcare system Exclusion Criteria: 1. Personal history of breast carcinoma, either invasive or ductal carcinoma in situ (DCIS) 2. Prior history of atypical breast lesion, lobular carcinoma in situ or chest wall irradiation 3. Known condition or suspicion of a very high risk predisposition to breast cancer: germline mutation of BRCA1/2, PALB2, TP53 or equivalent 4. History of bilateral mastectomy 5. Recent abnormal breast finding under work-up (clinically suspect lesion or BI-RADS 4 or 5 image) 6. Psychiatric or other disorders that are not compatible with compliance to the protocol requirements and follow-up 7. Women who do not intend to be followed-up for 4 years

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast screening

Contacts and locations

Locations

  • AUSL Reggio Emilia

    Reggio Emilia, Emilia-Romagna, Italy

  • Assuta Medical Center Ramat HaHayal

    Tel Aviv, Israel

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, Cambridgeshire, United Kingdom

  • Gustave roussy

    Villejuif, France

  • Institut Jules Bordet

    Brussels, Belgium

  • Marta Romản

    Barcelona, Spain

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