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GRAnulomatous MAstitis REGistry Study

Study acronym: GRAMAREG
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Notable Recruitment opened
    • Start date changed from estimate of Apr 1, 2026 to Jul 1, 2026
    • Eligibility criteria expanded, about 7 words
    • Site details revised at 2 of 2 sites
  2. Minor Study Status, Eligibilityv2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07422870
Lead Sponsor European Breast Cancer Research Association of Surgical Trialists
Conditions
(from sponsor)
Idiopathic Granulomatous Mastitis, Granulomatous Mastitis
Related terms Cystic Fibrosis, Granulomatous Mastitis, Mastitis
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov