Clinical trial NCT06667609: Validity and Reliability of the Mastitis Symptom Severity Assessment Methods (M-Score and BISSI) in Non-Lactational Mastitis
Official title: Validity and Reliability of the Mastitis Symptom Severity Assessment Methods (M-Score and BISSI) in Non-Lactational Mastitis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Granulomatous Mastitis
Mastitis Chronic
Keywords: M-score
validity
reliability
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-10-31
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female diagnosed with NL-GLM/PDM in China

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.

Eligibility criteria: 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 outcomes:
measure: Inter-rater Reliability
timeFrame: 8 weeks
measure: Test-Retest Reliability
timeFrame: 8 weeks
measure: Clinical Validity
timeFrame: 8 weeks
Secondary outcomes:
measure: Correlation between the M-score/BISSI with laboratory indicators
timeFrame: 8 weeks
measure: Cutoff value for M-score/BISSI to defined clinical complete remission.
timeFrame: 8 weeks
measure: Correlation between the M-score and BISSI scores.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Chaozhou
country: China
facility: Chaozhou Maternal and Child Health Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen memorial Hospital, Sun Yat-sen University
state: Guangdong
city: Jiangmen
country: China
facility: Jiangmen Maternity and Child Health Care Hospital
state: Guangdong
Study officials:
References:
citation: Heron E, McArdle A, Karim MN, Cooper M, Geddes D, McKenna L. Construct validity and internal consistency of the Breast Inflammatory Symptom Severity Index in lactating mothers with inflammatory breast conditions. PeerJ. 2021 Nov 16;9:e12439. doi: 10.7717/peerj.12439. eCollection 2021.
citation: Chen X, Huang H, Huang H, Yong J, Zhu L, Chen Q, Tan L, Zeng Y, Yang Y, Zhao J, Rao N, Ding L, Wu W, Li Y, Gui X, Ye L, Xu Y, Jiang Y, Su L, Xiao Q, Cai X, Hu T, Tan C, Liu Q, Liu S, Zhao J, Wang Y, Yu F, Zhang J, Li S, Chen K. Ductal lavage followed by observation versus oral corticosteroids in idiopathic granulomatous mastitis: A randomized trial. Nat Commun. 2024 Oct 23;15(1):9144. doi: 10.1038/s41467-024-53143-2.