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Structured Treatment and Evaluation Pathway for Granulomatous Mastitis

Development and Clinical Validation of Structured Evidence of Informed Clinical Pathway for Granulomatous Mastitis: A mixed method study - STEP-GM

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/02/103915
Enrollment
75
Registered
2026-02-16
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Health Condition 1: N611- Abscess of the breast and nipple

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil

Sponsors

All India Institute of Medical Sciences, Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Women above 18 years of age with clinical diagnosis of granulomatous mastitis. 2. Patients giving consent to enroll in the study.

Exclusion criteria

Exclusion criteria: 1. Non-consenting females. 2. Pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
Number of patients with complete clinical response as defined by resolution of all clinical and radiologic signs of disease at 6 monthsTimepoint: 3, 6 months—

Secondary

MeasureTime frame
Time to remission as measured by duration from start of treatment to appearance of complete response.Timepoint: 3, 6 months;Patient-reported outcome measures for quality-of-life using pre-defined questionnaireTimepoint: 0, 6 months—

Countries

India

Contacts

Public ContactDr Suhani

All India Institute of Medical Sciences(AIIMS) New Delhi

drsuhani@gmail.com01126551816

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026