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Multicenter Clinical Characteristics and Targeted Metabolomic Analysis of Granulomatous Lobular Mastitis in the Cold Regions of Northern China

Multicenter Clinical Characteristics and Targeted Metabolomic Analysis of Granulomatous Lobular Mastitis in the Cold Regions of Northern China

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500107206
Enrollment
Unknown
Registered
2025-08-06
Start date
2025-08-06
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Granulomatous Mastitis

Interventions

Cold Region Group:None. Collection of blood and fecal samples for metabolomic and gut microbiota analysis
Non-Cold Region Group:None. Same as above: collection of blood and fecal samples for analysis

Sponsors

The Sixth Affiliated Hospital of Harbin Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Female, aged 18–50 years; 2. Diagnosed with granulomatous lobular mastitis (GLM), confirmed by imaging or pathology; 3. Resided in either cold or non-cold regions for at least one year, with place of residence allowing clear group classification; 4. Willing to sign informed consent and complete questionnaires and sample collection; 5. No systemic immunosuppressive therapy (e.g., biologics) in the past year; 6. First-episode or recurrent cases with complete clinical records.

Exclusion criteria

Exclusion criteria: 1. Presence of confirmed malignancies, breast cancer, or Paget’s disease of the breast; 2. Severe psychiatric disorders, cognitive impairment, or communication barriers that prevent study completion; 3. Coexisting systemic autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis); 4. History of extensive breast resection surgery due to prior breast diseases.

Design outcomes

Primary

MeasureTime frame
Differences in Clinical Characteristics of GLM Patients in Alpine and Non-Alpine Regions;

Countries

China

Contacts

Public ContactLei Zhong

Affiliated with Harbin Medical University

zhongleiyd@126.com+86 137 9663 6149

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026