Idiopathic granulomatous mastitis patient registry
Official title: A Retrospective / Prospective Cohort Study to Evaluate the Incidence, Diagnostic Features, Clinical Course and Treatment Strategies in Histologically Confirmed Idiopathic Granulomatous Mastitis
Run by European Breast Cancer Research Association of Surgical Trialists · NCT07422870 · Data updated 2026-11-12
This registry collects real-world information from adults with idiopathic granulomatous mastitis to understand how the condition presents, is diagnosed, and progresses in Europe.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | European Breast Cancer Research Association of Surgical Trialists Research network |
| Locations | 2 sites (Düsseldorf, North Rhine-Westphalia and 1 other locations) |
| Status | Recruiting |
| Started | July 1, 2026 |
| Main results expected | April 1, 2031 |
| Study ends | April 1, 2036 |
| Registry record updated | September 15, 2026 |
| Trial ID | NCT07422870 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) of any sex with histologically confirmed idiopathic granulomatous mastitis or cystic neutrophilic granulomatous mastitis, diagnosed after January 1, 2015, who consent to participate in the prospective portion.
✕Probably not a fit
Patients without histological confirmation or those with secondary granulomatous conditions may not benefit from registry findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The GRAMAREG registry is an international, non-interventional observational study combining retrospective and prospective data for patients with histologically confirmed idiopathic granulomatous mastitis (IGM) or cystic neutrophilic granulomatous mastitis. It aims to describe incidence, diagnostic features, clinical course, treatment strategies, and outcomes by collecting data from multiple European sites since 2015. Enrollment is unlimited and the registry remains open to capture ongoing patient experiences, reflecting the disease's rarity. Eligibility requires histological confirmation and informed consent for the prospective portion; both retrospective and prospective data contribute to a comprehensive cohort.
Why it matters
Potential benefit: If successful, the registry could clarify how IGM presents and is managed, potentially informing future guidelines and decision-making for patients and clinicians.
How similar studies have gone: Previous reports on IGM are largely case-based; this registry offers a structured, multi-center approach to collect broader, real-world data.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
University Hospital Düsseldorf
Düsseldorf, North Rhine-Westphalia, Germany Recruiting -
Department of Gynecology and Obstetrics University Hospital Schleswig-Holstein
Lübeck, Schleswig-Holstein, Germany Recruiting
Study contacts
- Study coordinator: Natalia Krawczyk, PD Dr. med.
- Email: Natalia.Krawczyk@med.uni-duesseldorf.de
- Phone: +49 0211 0
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.