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Observation Alone for Mild Non-Lactational Mastitis

NCT06665399 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 57

Last updated 2025-09-23

No results posted yet for this study

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.

Conditions

  • Granulomatous Mastitis
  • Mastitis Chronic

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.

Sponsors & Collaborators

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-11
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06665399 on ClinicalTrials.gov