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RECRUITING
NCT06665399

Observation Alone for Mild Non-Lactational Mastitis

Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

View on ClinicalTrials.gov

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.

Official title: Observation Alone for Mild Non-Lactational Mastitis: A Cohort Study.

Key Details

Gender

FEMALE

Age Range

18 Years - 65 Years

Study Type

OBSERVATIONAL

Enrollment

57

Start Date

2024-09-11

Completion Date

2027-12-31

Last Updated

2025-09-23

Healthy Volunteers

No

Interventions

OTHER

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, 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.

Locations (2)

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

Guangzhou, Guangdong, China

Shenshan Medical Center, Sun Yat-sen Memorial Hospital

Shanwei, Guangdong, China