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New european registry aims to unlock mysteries of rare breast disease

NCT ID NCT07422870

Knowledge-focused Sponsor: European Breast Cancer Research Association of Surgical Trialists 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 2 times

Summary

This study is creating a European registry for people with idiopathic granulomatous mastitis (IGM), a rare inflammatory breast condition that causes pain, redness, and abscesses. Researchers will collect information from 1,000 participants to better understand symptoms, treatments, and long-term outcomes. The goal is to improve diagnosis and care for this poorly understood disease.

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.

Participants

About 1,000 people

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

Started

Jul 2026

Expected to finish

Apr 2036

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

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

Who is studied

Patients diagnosed with histologically confirmed idiopathic granulomatous mastitis (IGM) or cystic neutrophilic granulomatous mastitis (CNGM) at participating European breast centers and hospitals. The population includes both retrospectively identified patients (diagnosed January 1, 2015, through Study Site activation) and prospectively enrolled patients (diagnosed after Study Site activation). IGM predominantly affects women of childbearing age, mostly parous, and more frequently of non-white ethnicity, though both males and females ≥18 years are eligible.

Ages

18 years and older

Sex

Anyone

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: * Histologically confirmed idiopathic granulomatous mastitis OR cystic neutrophilic granulomatous mastitis by local pathology (minimally invasive biopsy or histological confirmation on surgical specimen) * First histological confirmation after January 1, 2015 * Female or male patients ≥18 years old * Signed informed consent form for all patients included in prospective part of the study (patients presenting with idiopathic granulomatous mastitis after activation of the study at Study Site) Exclusion Criteria: * Patients with suspicion of idiopathic granulomatous mastitis but without histological confirmation * Suspicion of OR confirmed secondary granulomatous mastitis due to: * Tuberculosis, Sarcoidosis, Fungal infection, Parasitic infection, Foreign body reaction

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Conditions

The condition(s) this trial relates to.

cystic fibrosis granulomatous mastitis mastitis

As listed by the trial registrant

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

Granulomatous mastitis Idiopathic granulomatous mastitis

How to take part

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

  1. The places running it

    2 sites. 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

  • Department of Gynecology and Obstetrics University Hospital Schleswig-Holstein

    RECRUITING

    Lübeck, Schleswig-Holstein, 23562, Germany

  • University Hospital Düsseldorf

    RECRUITING

    Düsseldorf, North Rhine-Westphalia, 40225, Germany

More trials for these conditions

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