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

Recruiting

• Conditions: Granulomatous Mastitis; Mastitis Chronic

• Registration Number: NCT06667609
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief 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.

Detailed Description

Non-lactational granulomatous lobular/periductal mastitis (NL-GLM/PDM) are inflammatory breast diseases with unclear etiology, usually manifested as palpable breast mass, accompanied by breast pain and abscesses, erythema or fistula formation. There is no well-recognized assessment tool for evaluating the symptom severity and treatment efficacy of NL-GLM/PDM. In our previous studies with NL-GLM, we used the Mastitis-score (M-score) as a physician-directed measure of the symptom severity. However, there were no patient-reported outcome measure for NL-GLM/PDM. The Breast Inflammatory Symptom Severity Index(BISSI) was reported as a valid patient-reported outcome measure for lactational mastitis. Its clinical validity as a measure of Symptom Severity for NL-GLM/PDM are still unclear.

In this multicenter, prospective cohort study, we will validate the validity and reliability of the M-score, a physician-directed measure, and the Breast Inflammatory Symptom Severity Index (BISSI), a patient-reported outcome (PRO) measure, for assessing symptom severity in patients with non-lactational granulomatous lobular/periductal mastitis (NL-GLM/PDM). Establishing the validity of these two approaches will facilitate the objective measurement of treatment efficacy for NL-GLM/PDM in the future.

Study Timeline

• Study Start: 2024-08-28
• Study First Submitted: 2024-10-30
• Study First Submitted QC: 2024-10-30
• Study First Posted: 2024-10-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-13
• Primary Completion: 2027-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Correlation between the M-score/BISSI with laboratory indicators	8 weeks	Explore the correlation between the M-score/BISSI with white blood cell counts, neutrophil counts, lymphocyte counts, neutrophil/lympocyte ratio, CRP, ESR, TNF-alpha, and IL-6.
Cutoff value for M-score/BISSI to defined clinical complete remission.	8 weeks	Investigate the optimal cutoff value of the M-score/BISSI for defining clinical complete remission.
Correlation between the M-score and BISSI scores.	8 weeks	Examine the correlation between the M-score and BISSI scores.

Trial Locations

Locations (3)

Chaozhou Maternal and Child Health Hospital; 🇨🇳 Chaozhou, Guangdong, China

Sun Yat-sen memorial Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

Jiangmen Maternity and Child Health Care Hospital; 🇨🇳 Jiangmen, Guangdong, China