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New gene test may spot hidden breast cancer in Hard-to-Diagnose lesions

NCT ID NCT07428733

Diagnosis Sponsor: Institute of Oncology Ljubljana 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether checking for certain gene changes (methylation of BRCA1, RASSF1A, and PTEN) in breast tissue samples can help doctors tell the difference between harmless and cancerous breast lesions. Researchers tested tissue from 401 women with breast lesions that were hard to diagnose using standard methods. The goal was to see if these gene tests could improve diagnostic accuracy and help guide treatment decisions.

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 lead to a more accurate diagnostic test for breast lesions, reducing unnecessary surgeries or missed cancers.
What could go wrong
This is a completed diagnostic study, not a treatment trial. The test may not prove accurate enough for routine use, and results may not change current clinical practice.

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

401 people

The number who actually took part.

Started

Sep 2024

Finished

Jan 2026

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 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Female patients aged 18 years or older. * Patients referred for diagnostic evaluation of breast lesions of uncertain malignant potential. * Availability of breast tissue samples obtained by diagnostic needle biopsy. * Written informed consent for participation in the study. Exclusion Criteria: * Male patients. * Patients younger than 18 years. * Patients without breast lesions or without indication for diagnostic biopsy. * Inadequate or insufficient tissue material for molecular analysis. * Withdrawal of informed consent.

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As listed by the trial registrant

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

Breast lesions of uncertain malignant potential PTEN

Contacts and locations

Locations

  • Institute of Oncology Ljubljana

    Ljubljana, 1000, Slovenia

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