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A genetic score could sharpen breast cancer risk prediction

NCT ID NCT06922708

Prevention Sponsor: Catholic University of the Sacred Heart Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 31, 2026 · Last updated Aug 04, 2026 · Updated 2 times

Summary

This study tests whether adding a polygenic risk score (PRS) — a measure based on 313 genetic markers — to the standard CanRisk model can improve breast cancer risk prediction and prevention. About 100 women at increased risk will receive genetic counseling, a blood draw, and the PRS result, then answer questionnaires about their understanding and emotional response. The goal is to see if this integrated approach is practical, acceptable, and helpful in a real-world clinic setting.

What this could mean

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

Active substance
Polygenic risk score (PRS) testing integrated into the CanRisk model, alongside standard genetic counseling
What this could lead to
If successful, this could make breast cancer risk prediction more precise, enabling earlier and more personalized prevention strategies for women at higher risk.
What could go wrong
This is a small feasibility study, not a large trial, so it may not prove that PRS improves outcomes. The added psychological impact and the complexity of integrating PRS into routine care are also potential challenges.

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

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Nov 2026

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

18 to 79 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: * Ability to provide informed consent * Voluntary consent to participate * Estimated risk of carrying an inherited pathogenic variant (in BRCA1, BRCA2, PALB2, CHEK2, ATM, RAD51D, RAD51C, BARD1) \> 5%, (calculated on www.canrisk.org) * Healthy women with: 1. Known family history of breast cancer, or 2. Known familiarity with carriers of pathogenic variants for genes included in the CanRisk model (BRCA1, BRCA2, PALB2, CHEK2, ATM, RAD51D, RAD51C, BARD1), or 3. Known carriers of pathogenic variants for genes included in the CanRisk model (BRCA1, BRCA2, PALB2, CHEK2, ATM, RAD51D, RAD51C, BARD1) * Affected women with: 1. Diagnosis of unilateral breast cancer 2. Personal history of ovarian cancer Exclusion Criteria: * Diagnosis or history of bilateral breast cancer * Diagnosis of ductal carcinoma in situ * Previous bilateral mastectomy * Life expectancy \< 12 months due to other medical conditions * Participation in interventional clinical trials for breast cancer prevention in the last 12 months * Carriers or relatives of carriers of pathogenic variants in genes not included in the CanRisk model (genes other than BRCA1, BRCA2, PALB2, CHEK2, ATM, RAD51D, RAD51C, BARD1) * Inability to provide informed consent

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm Genetic Risk Score ovarian cancer

As listed by the trial registrant

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

Breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Policlinico Universitario Fondazione Agostino Gemelli

    RECRUITING

    Roma, Italy

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