Actively Recruiting

Age: 18Years - 65Years
FEMALE
NCT06665399

Observation Alone for Mild Non-Lactational Mastitis

Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2025-09-23

57

Participants Needed

2

Research Sites

172 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Observation Alone for Mild Non-Lactational Mastitis

Who Can Participate

Age: 18Years - 65Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female, aged 18 to 65 years
  • Clinically diagnosed with possible non-lactational granulomatous lobular mastitis or periductal mastitis (more than 6 months since stopping breastfeeding)
  • Mscore less than or equal to 3 points
  • Patients with localized breast abscess must have had abscess drainage before enrollment
  • Willingness to undergo observation and follow-up after education and discussion with primary physician
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Confirmed or suspected breast malignancy
  • Bilateral mastitis (simultaneous or sequential onset)
  • Currently pregnant
  • Non-lactational mastitis in the same breast within past year treated with surgery, oral corticosteroids for more than 2 weeks, anti-tuberculosis treatment for more than 2 weeks, or ductal lavage therapy
  • Surgery, oral corticosteroids, or anti-tuberculosis treatment for non-lactational mastitis in the same breast within 2 weeks before enrollment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China, 510120

Actively Recruiting

2

Shenshan Medical Center, Sun Yat-sen Memorial Hospital

Shanwei, Guangdong, China, 516600

Actively Recruiting

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Research Team

K

Kai Chen, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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