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NCT07422870: GRAMAREG
GRAnulomatous MAstitis REGistry Study
trial in Idiopathic Granulomatous Mastitis in 1,000 participants. Not yet recruiting.
1 April 2031
Quick facts
| Lead sponsor | European Breast Cancer Research Association of Surgical Trialists |
|---|---|
| Status | Not yet recruiting |
| Study type | OBSERVATIONAL |
| Enrollment | 1,000 |
| Start date | 1 April 2026 |
| Primary completion | 1 April 2031 |
| Estimated completion | 1 April 2036 |
| Sites | 2 locations across Germany |
Conditions studied
- Idiopathic Granulomatous Mastitis — all drugs for Idiopathic Granulomatous Mastitis →
- Granulomatous Mastitis — all drugs for Granulomatous Mastitis →
Sponsor
European Breast Cancer Research Association of Surgical Trialists
Who can join
18 and older, any sex, with Idiopathic Granulomatous Mastitis or Granulomatous Mastitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07422870
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Idiopathic Granulomatous Mastitis
Currently open trials in the same condition.
- NCT05852171 — Baricitinib in Idiopathic Granulomatous Mastitis · Phase 2 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07422870 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by European Breast Cancer Research Association of Surgical Trialists
- Last refreshed: 27 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07422870.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing