Validity and Reliability of the Mastitis Symptom Severity Assessment Methods (M-Score and BISSI) in Non-Lactational Mastitis

StatusCompleted
PhaseNot specified
Started

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Record History

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  1. Trial completed Show 5 more changesShow less
    • Primary and study completion dates changed from estimate of May 26, 2026 to May 12, 2026
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 2 of 3 entries
    • Study sites revised (5)
    • Publications: details revised at 2 of 2 entries
  2. Primary and study completion dates: Jun 30, 2027 to May 26, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 300 to confirmed 320
    • Site details revised at 5 of 5 sites
    v4
  3. Study sites: 3 to 5
    • Publications: details revised at 2 of 2 entries
    v3
  4. Site details revised at 3 of 3 sitesv2
  5. Study First Submitted
  • 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.
The purpose of this study is to evaluate the validity and reliability of the Mastitis-score (M-score) and the Breast Inflammatory Symptom Severity Index (BISSI) as measures for assessing symptom severity in non-lactational granulomatous lobular/periductal mastitis (NL-GLM/PDM). This research aims to provide a valid and reliable tool for evaluating both symptom severity and treatment efficacy in NL-GLM/PDM.
Trial Details
NCT Number NCT06667609
Lead Sponsor Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions
(from sponsor)		 Granulomatous Mastitis, Mastitis Chronic
Related terms Granulomatous Mastitis
Enrollment 320 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov