Active — Not RecruitingNot Applicable

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

China320 participantsStarted 2024-08-28

Plain-language summary

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.

Who can participate

Age range18 Years – 65 Years

SexFEMALE

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Inclusion criteria

✓. Female, age between 18 and 65 years;
✓. Clinically considered as Non-Lactational mastitis;
✓. Clinically and Pathologically confirmed NL-GLM/PDM;
✓. Patients planning to receive treatment or observation alone;
✓. Signed the informed consent form

Exclusion criteria

✕. Patients with confirmed or suspected malignant breast tumors
✕. Patients with bilateral mastitis (including those with bilateral Non-Lactational Mastitis occurring simultaneously or successively)
✕. Pregnant.

What they're measuring

Inter-rater Reliability

Timeframe: 8 weeks

Test-Retest Reliability

Timeframe: 8 weeks

Clinical Validity

Timeframe: 8 weeks

Trial details

NCT IDNCT06667609

SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-05-26

View on ClinicalTrials.gov More Granulomatous Mastitis trials