Not yet recruitingOBSERVATIONAL

GRAnulomatous MAstitis REGistry Study

This study, called GRAMAREG, is collecting information about a rare breast condition known as idiopathic granulomatous mastitis (IGM). IGM causes painful breast inflammation, sometimes leading to abscesses, and can be difficult to treat. Because it's so uncommon, doctors don't yet have a lot of clear information about it. This study is the first European effort to systematically gather details from patients with IGM. It looks at how the condition starts, how it's diagnosed, the course it takes, and what treatments are used. By collecting this data, researchers hope to gain a much better understanding of IGM, which will help improve diagnosis and treatment for patients in the future.

At a glance

Status

Not yet recruiting

Sponsor

European Breast Cancer Research Association of Surgical Trialists

Enrolment target

1,000

Start

01 Apr 2026

Estimated completion

01 Apr 2036

Idiopathic Granulomatous Mastitis Granulomatous Mastitis

What is this study about?

This study is called the GRAnulomatous MAstitis REGistry, or GRAMAREG. It's focused on a rare breast condition called idiopathic granulomatous mastitis (IGM), which causes inflammation in the breast. The word "idiopathic" means the cause is unknown. Women with IGM can experience a lot of pain, redness, and breast lumps, and sometimes develop abscesses (collections of pus) that don't go away easily. These symptoms can be very worrying and sometimes confused with other serious conditions like breast cancer.

Because IGM is so uncommon, doctors don't have a lot of clear information about the best ways to diagnose and treat it. This study aims to change that. It's the first effort in Europe to systematically collect information from people who have been diagnosed with IGM. By bringing together data from many different patients, researchers hope to get a much clearer picture of who gets IGM, what its symptoms are like, how it's diagnosed, what treatments are tried, and how patients recover.

This is an "observational" study, which means doctors will simply record information about your condition and treatment as part of your usual care. You won't be given any new or experimental treatments for the study. The information gathered will help doctors and researchers better understand IGM, leading to improved care and treatment recommendations for patients in the future.

Key takeaways

The study aims to understand a rare breast condition called granulomatous mastitis.
It's an 'observational' study, meaning no new treatments are given for research.
Information gathered will help improve diagnosis and treatment for future patients.
You won't have extra appointments for the study.
Your privacy is protected, and you can withdraw anytime.

Who may be eligible?

To be considered for this study, you need to have a specific type of breast inflammation called idiopathic granulomatous mastitis or cystic neutrophilic granulomatous mastitis. This diagnosis must have been confirmed by a lab test on a tissue sample (like a biopsy), and this confirmation must have happened after January 1, 2015. You also need to be 18 years old or older.

If you meet these criteria and are interested in joining the study, the doctors will explain everything in detail. If you decide to take part, you'll be asked to sign a consent form, which means you agree to let them use your health information for the study.

However, you cannot join if your breast inflammation is caused by something else, such as infections like tuberculosis, fungal infections, or parasites, or other conditions like sarcoidosis or a reaction to foreign material in the breast. The study is specifically looking at IGM when the cause is unknown, not when it's linked to these other identified causes.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have I been diagnosed with idiopathic granulomatous mastitis or cystic neutrophilic granulomatous mastitis by a lab test?
Was my diagnosis confirmed after January 1, 2015?
Am I 18 years old or older?
Is my breast inflammation NOT caused by an infection (like TB) or another known condition?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it's important to know that it is an "observational" study. This means that you won't receive any new medications or treatments specifically for the study. All your diagnostic tests and treatments will be part of your normal medical care, following your doctor's usual standards. The study team will simply gather information from your medical records about your condition, how it was diagnosed, the treatments you've received, and how you responded to them.

For most people joining, the study will involve collecting information about your health over a period of up to five years. This helps track how long your symptoms last and if the condition comes back. You won't have extra clinic visits just for the study. Your appointments will be your normal medical appointments, and the study team will collect relevant information from these visits. The overall goal is to understand the long-term journey of granulomatous mastitis.

Potential risks and benefits

There are no direct medical risks from participating in this study as you won't receive any new treatments or tests. Your medical care will continue as normal. The main benefit is that the information collected about your journey with granulomatous mastitis will help researchers learn more about this rare condition. This knowledge can lead to better understanding, diagnosis, and treatment strategies for future patients. You have the right to withdraw from the study at any time without giving a reason, and it will not affect your medical care.

Locations (2)

University Hospital Düsseldorf
Verified postcode
Düsseldorf, Germany
Department of Gynecology and Obstetrics University Hospital Schleswig-Holstein
Verified postcode
Lübeck, Germany

Common questions

What is idiopathic granulomatous mastitis (IGM)?

It's a rare breast condition that causes inflammation, pain, and sometimes abscesses, and its cause isn't known.

Will I get new treatments if I join this study?

No, this is an observational study. You will receive your usual medical care, and the study team will simply collect information about it.

How long will I be involved in the study?

If you join the prospective part, information about your condition will be collected for up to 5 years, as part of your regular check-ups.

Is my personal information kept private?

Yes, all your information is handled with care to protect your privacy and is kept anonymous where possible.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time, and it won't affect your medical care.

How to find out more

Natalia Krawczyk, PD Dr. med.

natalia.krawczyk@med.uni-duesseldorf.de +49 0211 0 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.