Observation Alone for Mild Non-Lactational Mastitis
China57 participantsStarted 2024-09-11
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexFEMALE
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Inclusion criteria
✓. Female, aged 18 to 65 years;
✓. Clinically diagnosed with possible non-lactational (more than 6 months since stopping breastfeeding) granulomatous lobular mastitis or periductal mastitis.
✓. Mscore ≤ 3 points;
✓. Patients with ultrasound findings suggesting localized breast abscess formation must have undergone abscess drainage before enrollment;
✓. 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;
✓. Signed informed consent form.
Exclusion criteria
✕. Patients with confirmed or suspected breast malignancy;
✕. Patients with bilateral mastitis (including those with bilateral simultaneous onset and those with sequential onset of non-lactational granulomatous mastitis);
✕
What they're measuring
1
12-weeks Progression Free Proportion
Timeframe: 12 weeks after enrollment
2
12-weeks Treatment Free Proportion
Timeframe: 12 weeks after enrollment
Trial details
NCT IDNCT06665399
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University
. Pregnant patients who are currently in the gestation period;
✕. 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.
✕. Patients who received surgery, oral corticosteroids, or anti-tuberculosis treatment for the non-lactational mastitis of the ipsilateral breast within 2 weeks before enrollment.