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New gene test may prevent unnecessary breast surgeries

NCT ID NCT07416500

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 testing for certain gene changes (methylation) can help doctors tell if a breast lesion is cancerous or not. 301 women with suspicious breast lumps had standard biopsies plus extra gene testing. The goal was to see if the gene test could improve diagnosis and reduce the need for surgery on harmless lesions.

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

301 people

The number who actually took part.

Started

Sep 2024

Finished

Jun 2025

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 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 participants aged 40 years or older * Suspicious non-palpable breast lesion referred for diagnostic evaluation at the Institute of Oncology Ljubljana * Undergoing image-guided core needle biopsy or surgical excision as part of standard diagnostic work-up * Availability of sufficient breast tissue sample for methylation analysis Signed written informed consent Exclusion Criteria: * Contraindications to standard diagnostic procedures * Insufficient tissue sample for molecular analysis * Withdrawal of informed consent

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

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

Breast cancer Breast lesions of uncertain malignant potential (B3 lesions)

Contacts and locations

Locations

  • Institute of Oncology Ljubljana

    Ljubljana, 1000, Slovenia

More trials for these conditions

Other studies related to the condition(s) this trial covers.