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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
RECRUITING
Guangzhou
Shenshan Medical Center, Sun Yat-sen Memorial Hospital
RECRUITING
Shanwei
Contact Information
Primary
Kai Chen, MD
chenkai23@mail.sysu.edu.cn
86-020-34070463
Time Frame
Start Date: 2024-09-11
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 57
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

This content was sourced from clinicaltrials.gov