Clinical trial NCT06665399: Observation Alone for Mild Non-Lactational Mastitis
Official title: Observation Alone for Mild Non-Lactational Mastitis: a Cohort Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Granulomatous Mastitis
Mastitis Chronic
Keywords: Granulomatous Mastitis, Observation, Treatment
Periductal mastitis
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-10-30
Enrollment: 57
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Female, aged 18 to 65 years;
2. Clinically diagnosed with possible non-lactational (more than 6 months since stopping breastfeeding) granulomatous lobular mastitis or periductal mastitis.
3. Mscore ≤ 3 points;
4. Patients with ultrasound findings suggesting localized breast abscess formation must have undergone abscess drainage before enrollment;
5. After education, participants should have a strong willingness for observation and follow-up, and, after discussing with the primary physician, jointly decide to proceed with observation and follow-up;
6. Signed informed consent form.

Exclusion Criteria:

1. Patients with confirmed or suspected breast malignancy;
2. Patients with bilateral mastitis (including those with bilateral simultaneous onset and those with sequential onset of non-lactational granulomatous mastitis);
3. Pregnant patients who are currently in the gestation period;
4. Patients who have had non-lactational mastitis in the same breast within the past year and have undergone treatments such as surgery, oral corticosteroids (for more than 2 weeks), anti-tuberculosis treatment (for more than 2 weeks), or ductal lavage therapy.
5. Patients who received surgery, oral corticosteroids, or anti-tuberculosis treatment for the non-lactational mastitis of the ipsilateral breast within 2 weeks before enrollment.

Primary outcomes:
measure: 12-weeks Progression Free Proportion
timeFrame: 12 weeks after enrollment
measure: 12-weeks Treatment Free Proportion
timeFrame: 12 weeks after enrollment
Secondary outcomes:
measure: 4-weeks Progression Free Proportion
timeFrame: 4 weeks after enrollment
measure: 24-weeks Progression Free Proportion
timeFrame: 24 weeks after enrollment
measure: 4-weeks Treatment Free Proportion
timeFrame: 4 weeks after enrollment
measure: 24-weeks Treatment Free Proportion
timeFrame: 24 weeks after enrollment
measure: Median time to progression
timeFrame: 24 weeks after enrollment
measure: Median time to treatment intervention
timeFrame: 24 weeks after enrollment
Other outcomes:
measure: Correlation between blood test indicators with clinical outcomes
timeFrame: 24 weeks after enrollment
measure: Correlation between clinicopathological biomarkers with clinical outcomes
timeFrame: 24 weeks after enrollment
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
References:
citation: 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.