Idiopathic Granulomatous MastitisGRAMAREGNCT07422870
GRAnulomatous MAstitis REGistry Study
An observational study of Idiopathic Granulomatous Mastitis and Granulomatous Mastitis, run by European Breast Cancer Research Association of Surgical Trialists at 2 sites in Germany.
Trial summary
Idiopathic granulomatous mastitis (IGM) is a rare benign inflammatory breast condition with unknown cause, affecting approximately 2.4 per 100,000 women aged 20-40 years. Patients experience severe local symptoms including pain, redness, and recurrent abscesses that can last weeks to months and often mimic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Granulomatous Mastitis, Granulomatous Mastitis
- How many people
- 1,000 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Jul 2026to 1 Apr 2036
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Recruiting
University Hospital Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40225
Natalia Krawczyk, PD Dr. med., +49211 81 0, Natalia.Krawczyk@med.uni-duesseldorf.de
- Recruiting
Department of Gynecology and Obstetrics University Hospital Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23562
Maggie Banys-Paluchowski, Prof. Dr. med., +49451 500-41700, Maggie.Banys-Paluchowski@uksh.de
About this study
Official title: A Retrospective / Prospective Cohort Study to Evaluate the Incidence, Diagnostic Features, Clinical Course and Treatment Strategies in Histologically Confirmed Idiopathic Granulomatous Mastitis
Idiopathic granulomatous mastitis (IGM) is a rare benign inflammatory breast condition with unknown cause, affecting approximately 2.4 per 100,000 women aged 20-40 years. Patients experience severe local symptoms including pain, redness, and recurrent abscesses that can last weeks to months and often mimic inflammatory breast cancer. Due to its rarity, mostly case reports and case series exist in the literature, leading to limited knowledge about risk factors, optimal treatment strategies, and clinical outcomes.
The GRAMAREG study is the first European registry for patients with histologically confirmed idiopathic granulomatous mastitis. This retrospective/prospective observational cohort study aims to systematically evaluate the incidence, diagnostic features, clinical course, treatment strategies, and patient outcomes of this uncommon disease. The study collects both retrospective data (from January 1, 2015 onwards) and prospective data from participating sites across Europe.
All diagnostic and therapeutic procedures are conducted according to institutional standards in clinical routine, as this is a non-interventional study. Patients in the prospective cohort are followed for up to 5 years to document symptom duration and recurrence rates.
Read the detailed description
Background:
Idiopathic granulomatous mastitis was first described by Kessler and Wolloch in 1972. The etiology remains largely unknown due to its rare occurrence. Valid prevalence data in Europe are lacking, though incidence appears higher in low-income countries compared to Western Europe. IGM predominantly occurs in women of childbearing age, mostly parous and more frequently of non-white ethnicity.
The diagnosis is confirmed only by histological evaluation, typically using core needle biopsy. Patients commonly develop recurrent breast abscesses that do not improve with antibacterial medication and often require repeat incisions or drainages. IGM must be differentiated from granulomatous inflammation associated with duct ectasia, foreign material reactions, specific infections (tuberculosis, fungi, parasites), systemic granulomatous diseases (sarcoidosis), and cystic neutrophilic granulomatous mastitis (CNGM) linked to Corynebacterium species.
Treatment strategies described in literature include high-dose steroids, immunosuppressive agents, bromocriptine, antibiotics, surgical resection, or even mastectomy. However, no evidence-based treatment recommendations are currently available.
Study Design:
This is an investigator-initiated non-interventional observational international prospective/retrospective cohort study with unlimited accrual and open registry duration due to disease rarity.
Data Collection Methods:
Retrospective Phase:
Collection and analysis via anonymized electronic database maintained by EUBREAST e.V. Participating Study Sites identify and document patients with histologically confirmed IGM treated between January 1, 2015, and Study Site activation. No patient identifying information is disclosed or documented. Data are fully anonymous without prospective follow-up.
Prospective Phase:
Patients with histologically confirmed IGM presenting after Study Site activation are informed about possible participation. Written informed consent is obtained. Diagnostic management and treatment follow institutional standards without protocol deviation. Follow-up occurs at 1, 3, and 5 years after first diagnosis to evaluate current symptoms and document potential recurrence.
- Keywords
- Idiopathic granulomatous mastitis, IGM, Granulomatous mastitis, Cystic neutrophilic granulomatous mastitis, CNGM, Inflammatory breast disease, Benign breast disease, Chronic mastitis, Non-lactational mastitis, Breast inflammation, Patient registry, Cohort study, granulomatous lobular mastitis
- Medical subject headings
- Granulomatous Mastitis, Mastitis, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Idiopathic Granulomatous Mastitis Patients | Female and male patients ≥18 years old with histologically confirmed idiopathic granulomatous mastitis (IGM) or cystic neutrophilic granulomatous mastitis (CNGM) diagnosed after January 1, 2015. Histological confirmation obtained by minimally invasive biopsy or on surgical specimen by local pathology. Excludes patients with secondary granulomatous mastitis due to tuberculosis, sarcoidosis, fungal and parasitic infection, or foreign body. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Presenting with Specific Symptoms
Percentage of patients presenting with specific clinical symptoms including pain, redness, and palpable breast mass at initial presentation
Measured: At initial diagnosis (baseline)
Duration of Symptoms Depending on Treatment Strategy
Time from initial symptom onset to symptom resolution measured in weeks or months, stratified by treatment approach (systemic treatment, surgical intervention, conservative management)
Measured: From initial diagnosis through symptom resolution, up to 5 years
Secondary outcomes (6)
Type and Duration of Systemic Treatment
Specific systemic treatments received (e.g., corticosteroids, immunosuppressive agents, antibiotics) and duration of each treatment in weeks or months
Measured: From initial diagnosis through completion of treatment, up to 5 years
Number of Surgeries Performed
Total number of surgical procedures (incision, drainage, excision, mastectomy) required per patient
Measured: From initial diagnosis through 5 years follow-up
Recurrence Rate
Proportion of patients experiencing recurrence of idiopathic granulomatous mastitis after initial treatment
Measured: At 1, 3, and 5 years after first diagnosis
Risk Factors Associated with Recurrence
Identification of patient demographics, clinical characteristics, and treatment factors associated with disease recurrence
Measured: At 1, 3, and 5 years follow-up
Time to Histological Confirmation
Time interval in days or weeks between first symptom occurrence and first histological confirmation of idiopathic granulomatous mastitis
Measured: At baseline (from retrospective chart review or patient recall)
Presentation on Breast Imaging
Imaging characteristics on mammography, sonography, and MRI (if performed) as assessed by the International Steering Committee
Measured: At initial diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start1 Jul 2026
- Primary completion1 Apr 2031 (estimated)
- Study completion1 Apr 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Granulomatous MastitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- European Breast Cancer Research Association of Surgical Trialists
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07422870
- Sponsor's protocol ID
- EUBREAST-15
- Acronym
- GRAMAREG
- Status last verified
- Sep 2026
- First submitted
- 13 Feb 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective / Prospective Cohort Study to Evaluate the Incidence, Diagnostic Features, Clinical Course and Treatment Strategies in Histologically Confirmed Idiopathic Granulomatous Mastitis
- ClinicalTrials.gov ID
- NCT07422870
- Acronym / sponsor ID
- GRAMAREG / EUBREAST-15
- Keywords
- Idiopathic granulomatous mastitis, IGM, Granulomatous mastitis, Cystic neutrophilic granulomatous mastitis, CNGM, Inflammatory breast disease, Benign breast disease, Chronic mastitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- European Breast Cancer Research Association of Surgical TrialistsResearch network
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Apr 2031 (estimated)
- Study completion
- 1 Apr 2036 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Idiopathic granulomatous mastitis (IGM) is a rare benign inflammatory breast condition with unknown cause, affecting approximately 2.4 per 100,000 women aged 20-40 years. Patients experience severe local symptoms including pain, redness, and recurrent abscesses that can last weeks to months and often mimic inflammatory breast cancer. Due to its rarity, mostly case reports and case series exist in the literature, leading to limited knowledge about risk factors, optimal treatment strategies, and clinical outcomes.
The GRAMAREG study is the first European registry for patients with histologically confirmed idiopathic granulomatous mastitis. This retrospective/prospective observational cohort study aims to systematically evaluate the incidence, diagnostic features, clinical course, treatment strategies, and patient outcomes of this uncommon disease. The study collects both retrospective data (from January 1, 2015 onwards) and prospective data from participating sites across Europe.
All diagnostic and therapeutic procedures are conducted according to institutional standards in clinical routine, as this is a non-interventional study. Patients in the prospective cohort are followed for up to 5 years to document symptom duration and recurrence rates.
Detailed description
Background:
Idiopathic granulomatous mastitis was first described by Kessler and Wolloch in 1972. The etiology remains largely unknown due to its rare occurrence. Valid prevalence data in Europe are lacking, though incidence appears higher in low-income countries compared to Western Europe. IGM predominantly occurs in women of childbearing age, mostly parous and more frequently of non-white ethnicity.
The diagnosis is confirmed only by histological evaluation, typically using core needle biopsy. Patients commonly develop recurrent breast abscesses that do not improve with antibacterial medication and often require repeat incisions or drainages. IGM must be differentiated from granulomatous inflammation associated with duct ectasia, foreign material reactions, specific infections (tuberculosis, fungi, parasites), systemic granulomatous diseases (sarcoidosis), and cystic neutrophilic granulomatous mastitis (CNGM) linked to Corynebacterium species.
Treatment strategies described in literature include high-dose steroids, immunosuppressive agents, bromocriptine, antibiotics, surgical resection, or even mastectomy. However, no evidence-based treatment recommendations are currently available.
Study Design:
This is an investigator-initiated non-interventional observational international prospective/retrospective cohort study with unlimited accrual and open registry duration due to disease rarity.
Data Collection Methods:
Retrospective Phase:
Collection and analysis via anonymized electronic database maintained by EUBREAST e.V. Participating Study Sites identify and document patients with histologically confirmed IGM treated between January 1, 2015, and Study Site activation. No patient identifying information is disclosed or documented. Data are fully anonymous without prospective follow-up.
Prospective Phase:
Patients with histologically confirmed IGM presenting after Study Site activation are informed about possible participation. Written informed consent is obtained. Diagnostic management and treatment follow institutional standards without protocol deviation. Follow-up occurs at 1, 3, and 5 years after first diagnosis to evaluate current symptoms and document potential recurrence.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Idiopathic Granulomatous Mastitis Patients | – | –Female and male patients ≥18 years old with histologically confirmed idiopathic granulomatous mastitis (IGM) or cystic neutrophilic granulomatous mastitis (CNGM) diagnosed after January 1, 2015. Histological confirmation obtained by minimally invasive biopsy or on surgical specimen by local pathology. Excludes patients with secondary granulomatous mastitis due to tuberculosis, sarcoidosis, fungal and parasitic infection, or foreign body. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of Patients Presenting with Specific Symptoms
Time frame: At initial diagnosis (baseline)
Percentage of patients presenting with specific clinical symptoms including pain, redness, and palpable breast mass at initial presentation
Duration of Symptoms Depending on Treatment Strategy
Time frame: From initial diagnosis through symptom resolution, up to 5 years
Time from initial symptom onset to symptom resolution measured in weeks or months, stratified by treatment approach (systemic treatment, surgical intervention, conservative management)
6 secondary outcomes
Type and Duration of Systemic Treatment
Time frame: From initial diagnosis through completion of treatment, up to 5 years
Number of Surgeries Performed
Time frame: From initial diagnosis through 5 years follow-up
Recurrence Rate
Time frame: At 1, 3, and 5 years after first diagnosis
Risk Factors Associated with Recurrence
Time frame: At 1, 3, and 5 years follow-up
Time to Histological Confirmation
Time frame: At baseline (from retrospective chart review or patient recall)
Presentation on Breast Imaging
Time frame: At initial diagnosis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Granulomatous Mastitis and Granulomatous Mastitis, run by European Breast Cancer Research Association of Surgical Trialists at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natalia Krawczyk, PD Dr. med. (+49 0211 0, Natalia.Krawczyk@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients Presenting with Specific Symptoms (time frame: At initial diagnosis (baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.