Validity and Reliability of the Mastitis Symptom Severity Assessment Methods (M-Score and BISSI) in Non-Lactational Mastitis
NCT ID: NCT06667609
Last Updated: 2025-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2024-08-28
2027-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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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.
Any treatments regimen
Participants may receive any treatments in accordance with standard clinical practice, based on physicians' recommendations and patients' preferences.
Interventions
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Any treatments regimen
Participants may receive any treatments in accordance with standard clinical practice, based on physicians' recommendations and patients' preferences.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
2. Patients with bilateral mastitis (including those with bilateral Non-Lactational Mastitis occurring simultaneously or successively)
3. Pregnant.
18 Years
65 Years
FEMALE
No
Sponsors
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Responsible Party
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Chen Kai
Vice Director of Dept Breast Surgery.
Locations
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Chaozhou Maternal and Child Health Hospital
Chaozhou, Guangdong, China
Dongguan Maternal and Child Health Care Hospital
Dongguan, Guangdong, China
Sun Yat-sen memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Jiangmen Maternity and Child Health Care Hospital
Jiangmen, Guangdong, China
Shenshan Medical Center, Sun Yat-sen Memorial Hospital
Shanwei, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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SYSKY-2024-699-01
Identifier Type: -
Identifier Source: org_study_id
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