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The goal of this observational study is to investigate the disease progression rate and timing in patients with mild Non-Lactational Granulomatous Lobular / Periductal Mastitis (NL-GLM/PDM) during follow-up with observation alone strategy. The main questions it aims to answer are: What is the rate of disease progression in mild NL-GLM/PDM patients under observation, and what clinical and pathological factors are associated with this progression? Participants with diagnosis of mild NL-GLM/PDM will be monitored over a specified period, with data collected on their clinical outcomes and relevant factors influencing disease progression.
Non-Lactational Granulomatous Lobular / Periductal Mastitis (NL-GLM/PDM) is an inflammatory breast disease of unclear etiology, primarily characterized by the presence of breast masses. A variety of treatment approaches, including intralesional injection, ductal lavage therapy, or corticosteroids had been proposed. Recently, an increasing number of studies have demonstrated that an observation and follow-up strategy for mild cases can yield comparable efficacy. An international consensus recommends that this observation strategy may serve as a first-line treatment approach for mild NL-GLM patients, with additional therapies implemented only upon disease progression.However, in clinical practice, we have observed that some patients with mild NL-GLM/PDM experience disease progression during the observation period, necessitating further treatment. The proportion of this population and the specifics of their disease progression remain unknown. Additionally, the clinical and pathological factors associated with disease progression during observation have not been previously studied. This research aims to conduct a single-center, single-arm, prospective cohort study to investigate the rate and timing of disease progression in mild NL-GLM/PDM during observation, as well as to explore the clinical and pathological factors related to progression. The findings will provide further guidance for subsequent research and clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation | In this study, the definition of "observation" is that participants cannot receive the following treatments currently considered to have a clear efficacy for NL-GLM/PDM. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observation | Other | In this study, the definition of "observation" is that participants cannot receive the following treatments currently considered to have a clear efficacy for NL-GLM/PDM, including surgical treatments (minimally invasive excision or open excision, incision and drainage), ultrasound-guided aspiration, oral corticosteroid therapy, antibiotic treatment, anti-tuberculosis therapy, or ductal lavage therapy. As symptomatic management for pain, the use of NSAIDs is permitted. Additionally, for patients with fistulas or skin lesions, routine wound care is also allowed. These two interventions are not considered as receiving treatment intervention in this study. |
| Measure | Description | Time Frame |
|---|---|---|
| 12-weeks Progression Free Proportion | The proportion of patients who did not experience disease progression events within 12 weeks after enrollment. | 12 weeks after enrollment |
| 12-weeks Treatment Free Proportion | The proportion of patients who did not experience any predefined treatments within 12 weeks after enrollment. | 12 weeks after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 4-weeks Progression Free Proportion | The proportion of patients who did not experience disease progression events within 4 weeks after enrollment. | 4 weeks after enrollment |
| 24-weeks Progression Free Proportion |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between blood test indicators with clinical outcomes | Explore the correlation between baseline and week 4 inflammatory blood test indicators and their dynamic changes with disease progression and treatment intervention. | 24 weeks after enrollment |
| Correlation between clinicopathological biomarkers with clinical outcomes |
Inclusion Criteria:
Exclusion Criteria:
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Patients with non-lactational mastitis (defined as more than 6 months since stopping breastfeeding) who meet the eligibility criteria at the Breast Tumor Center of Sun Yat-sen Memorial Hospital, Sun Yat-sen University.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510120 | China | ||
| Shenshan Medical Center, Sun Yat-sen Memorial Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35473758 | Result | Yuan QQ, Xiao SY, Farouk O, Du YT, Sheybani F, Tan QT, Akbulut S, Cetin K, Alikhassi A, Yaghan RJ, Durur-Subasi I, Altintoprak F, Eom TI, Alper F, Hasbahceci M, Martinez-Ramos D, Oztekin PS, Kwong A, Pluguez-Turull CW, Brownson KE, Chandanwale S, Habibi M, Lan LY, Zhou R, Zeng XT, Bai J, Bai JW, Chen QR, Chen X, Zha XM, Dai WJ, Dai ZJ, Feng QY, Gao QJ, Gao RF, Han BS, Hou JX, Hou W, Liao HY, Luo H, Liu ZR, Lu JH, Luo B, Ma XP, Qian J, Qin JY, Wei W, Wei G, Xu LY, Xue HC, Yang HW, Yang WG, Zhang CJ, Zhang F, Zhang GX, Zhang SK, Zhang SQ, Zhang YQ, Zhang YP, Zhang SC, Zhao DW, Zheng XM, Zheng LW, Xu GR, Zhou WB, Wu GS. Management of granulomatous lobular mastitis: an international multidisciplinary consensus (2021 edition). Mil Med Res. 2022 Apr 26;9(1):20. doi: 10.1186/s40779-022-00380-5. |
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IPD could be shared if the studies were completed for two years, and approvals were obtained from the administrators.
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| ID | Term |
|---|---|
| D058890 | Granulomatous Mastitis |
| ID | Term |
|---|---|
| D008413 | Mastitis |
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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|
The proportion of patients who did not experience disease progression events within 24 weeks after enrollment.
| 24 weeks after enrollment |
| 4-weeks Treatment Free Proportion | The proportion of patients who did not experience predefined treatments within 4 weeks after enrollment. | 4 weeks after enrollment |
| 24-weeks Treatment Free Proportion | The proportion of patients who did not experience predefined treatments within 24 weeks after enrollment. | 24 weeks after enrollment |
| Median time to progression among Progressors | The median time of the first occurrence of a progression event among patients who experience disease progression. | 24 weeks after enrollment |
| Median time to treatment intervention among patients with active treatment | The median time of the first occurrence of a treatment intervention event among patients who experience treatment intervention. | 24 weeks after enrollment |
Explore the correlation between clinical indicators, pathological indicators, and ultrasound indicators at baseline with disease progression and treatment intervention. |
| 24 weeks after enrollment |
| Shanwei |
| Guangdong |
| 516600 |
| China |
| D000091642 | Urogenital Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |