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

NCT06667609 · tracked via the Priya Life Science China tracker

Sponsor

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

Phase

Observational

Started

2024-08-28

Last updated

2026-04-09

Condition(s) studied

Granulomatous MastitisMastitis Chronic

Investigational drug(s) / intervention(s)

Any treatments regimen

Any treatments regimen: Participants may receive any treatments in accordance with standard clinical practice, based on physicians' recommendations and patients' preferences.

Study 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.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

65 Years

Healthy volunteers

Inclusion Criteria: 1. Female, age between 18 and 65 years; 2. Clinically considered as Non-Lactational mastitis; 3. Clinically and Pathologically confirmed NL-GLM/PDM; 4. Patients planning to receive treatment or observation alone; 5. Signed the informed consent form Exclusion Criteria: 1. Patients with confirmed or suspected malignant breast tumors 2. Patients with bilateral mastitis (including those with bilateral Non-Lactational Mastitis occurring simultaneously or successively) 3. Pregnant.

Primary outcome measure(s)

Inter-rater Reliability — 8 weeks
This assesses the consistency of results from different evaluators regarding the various dimensions of the Mscore and the total M-score for the same patients at the same time.
Test-Retest Reliability — 8 weeks
This assesses the consistency of the M-score/BISSI results for the same patient at different times (within 1 week after enrollment), prior to treatment initiation and when symptoms have not changed significantly.
Clinical Validity — 8 weeks
This aims to estimate the correlation between the M-score/BISSI and its changes, and the BISSI and its changes, with traditional evaluator assessments or traditional patient self-assessments of treatment efficacy and its changes.

Trial sites (5)

Facility	City	Region
Chaozhou Maternal and Child Health Hospital	Chaozhou	Guangdong
Dongguan Maternal and Child Health Care Hospital	Dongguan	Guangdong
Sun Yat-sen memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong
Jiangmen Maternity and Child Health Care Hospital	Jiangmen	Guangdong
Shenshan Medical Center, Sun Yat-sen Memorial Hospital	Shanwei	Guangdong

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06667609 on ClinicalTrials.gov ↗ ← All trials in China