Observation Alone for Mild Non-Lactational Mastitis

NCT06665399 | Recruiting

• 1 other identifier: SYSKY-2024-708-01
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Granulomatous Mastitis, Observation, Treatment; Periductal mastitis

Outcome Measures

Primary Outcomes (2)

• 12-weeks Progression Free Proportion

  The proportion of patients who did not experience disease progression events within 12 weeks after enrollment.

  12 weeks after enrollment

• 12-weeks Treatment Free Proportion

  The proportion of patients who did not experience any predefined treatments within 12 weeks after enrollment.

  12 weeks after enrollment

Secondary Outcomes (6)

• 4-weeks Progression Free Proportion

  4 weeks after enrollment

• 24-weeks Progression Free Proportion

  24 weeks after enrollment

• 4-weeks Treatment Free Proportion

  4 weeks after enrollment

• 24-weeks Treatment Free Proportion

  24 weeks after enrollment

• Median time to progression

  24 weeks after enrollment

Other Outcomes (2)

• Correlation between blood test indicators with clinical outcomes

  24 weeks after enrollment

• Correlation between clinicopathological biomarkers with clinical outcomes

  24 weeks after enrollment

Study Arms (1)

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.

Other: Observation

Interventions

Observation OTHER

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.

Observation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with non-lactational mastitis (defined as more than 6 months since stopping breastfeeding) who meet the eligibility criteria at the Breast Tumor Center of Sun Yat-sen Memorial Hospital, Sun Yat-sen University.

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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.

Sponsors & Collaborators

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

Study Sites (2)

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

Guangzhou, Guangdong, 510120, China

RECRUITING

Shenshan Medical Center, Sun Yat-sen Memorial Hospital

Shanwei, Guangdong, 516600, China

RECRUITING

Related Publications (1)

• Yuan QQ, Xiao SY, Farouk O, Du YT, Sheybani F, Tan QT, Akbulut S, Cetin K, Alikhassi A, Yaghan RJ, Durur-Subasi I, Altintoprak F, Eom TI, Alper F, Hasbahceci M, Martinez-Ramos D, Oztekin PS, Kwong A, Pluguez-Turull CW, Brownson KE, Chandanwale S, Habibi M, Lan LY, Zhou R, Zeng XT, Bai J, Bai JW, Chen QR, Chen X, Zha XM, Dai WJ, Dai ZJ, Feng QY, Gao QJ, Gao RF, Han BS, Hou JX, Hou W, Liao HY, Luo H, Liu ZR, Lu JH, Luo B, Ma XP, Qian J, Qin JY, Wei W, Wei G, Xu LY, Xue HC, Yang HW, Yang WG, Zhang CJ, Zhang F, Zhang GX, Zhang SK, Zhang SQ, Zhang YQ, Zhang YP, Zhang SC, Zhao DW, Zheng XM, Zheng LW, Xu GR, Zhou WB, Wu GS. Management of granulomatous lobular mastitis: an international multidisciplinary consensus (2021 edition). Mil Med Res. 2022 Apr 26;9(1):20. doi: 10.1186/s40779-022-00380-5.

  PMID: 35473758 BACKGROUND

MeSH Terms

Conditions

Granulomatous Mastitis

Interventions

Observation

Condition Hierarchy (Ancestors)

Mastitis; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Kai Chen, MD

CONTACT

86-020-34070463; chenkai23@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Director of Dept. of Breast Surgery

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: October 30, 2024
• Study Start: September 11, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 23, 2025

Record last verified: 2025-09

Locations

CN (2)