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

NCT06667609 | Active Not Recruiting

• 1 other identifier: SYSKY-2024-699-01
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 5

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.

Conditions

Granulomatous Mastitis; Mastitis Chronic

Keywords

M-score; validity; reliability

Outcome Measures

Primary Outcomes (3)

• Inter-rater Reliability

  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.

  8 weeks

• Test-Retest Reliability

  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.

  8 weeks

• Clinical Validity

  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.

  8 weeks

Secondary Outcomes (3)

• Correlation between the M-score/BISSI with laboratory indicators

  8 weeks

• Cutoff value for M-score/BISSI to defined clinical complete remission.

  8 weeks

• Correlation between the M-score and BISSI scores.

  8 weeks

Study Arms (1)

1

This is an observational study with no predefined treatments for the enrolled patients. Participants may receive any treatments in accordance with standard clinical practice, based on physicians' recommendations and patients' preferences.

Other: Any treatments regimen

Interventions

Any treatments regimen OTHER

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

Also known as: Surgery, Corticosteroids, Ductal lavage, Anti-TB treatments, Observations, Aspirations, Immuno-suppression medications

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female diagnosed with NL-GLM/PDM in China

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (5)

Chaozhou Maternal and Child Health Hospital

Chaozhou, Guangdong, 521000, China

Location

Dongguan Maternal and Child Health Care Hospital

Dongguan, Guangdong, 523000, China

Location

Sun Yat-sen memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

Location

Jiangmen Maternity and Child Health Care Hospital

Jiangmen, Guangdong, 529051, China

Location

Shenshan Medical Center, Sun Yat-sen Memorial Hospital

Shanwei, Guangdong, 516600, China

Location

Related Publications (2)

• 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.

  PMID: 34820185 RESULT

• 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.

  PMID: 39443446 RESULT

MeSH Terms

Conditions

Granulomatous Mastitis

Interventions

Surgical Procedures, Operative; Adrenal Cortex Hormones; Watchful Waiting

Condition Hierarchy (Ancestors)

Mastitis; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Director of Dept Breast Surgery.

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: October 31, 2024
• Study Start: August 28, 2024
• Primary Completion (Estimated): May 26, 2026
• Study Completion (Estimated): May 26, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

CN (5)