NCT06667609

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 320 (actual)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Granulomatous Mastitis
• Mastitis Chronic

Interventions

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

Timeline

• Start date: 2024-08-28
• Primary completion: 2026-05-26
• Completion: 2026-05-26
• First posted: 2024-10-31
• Last updated: 2026-04-09

Locations

5 sites across 1 country: China