Medical and Surgical Treatment for Idiopathic Granulomatous Mastitis
MSTIGM
Evaluation of Topical Steroids and Surgical Treatment for Idiopathic Granulomatous Mastitis
1 other identifier
interventional
100
1 country
1
Brief Summary
This study evaluates the clinical response rate of topical steroids in the treatment of idiopathic granulomatous mastitis in female adults. Half of the participants will receive topical steroid and the other half will receive local wide surgical excision.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2017
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2016
CompletedFirst Posted
Study publicly available on registry
November 9, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedDecember 6, 2018
December 1, 2018
3.7 years
November 7, 2016
December 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
clinical response rate
The clinical response is categorized into ''completely healed,'' ''inadequately healed,'' ''stable,'' ''worsened,'' or ''relapsed'' if the lesions had once healed but symptoms returned.
six months
Secondary Outcomes (1)
granulomatous mastitis recurrence
two years
Study Arms (2)
medical
EXPERIMENTALHydrocortisone butyrate cream(0.1%) was applied to the breast by the patient twice a day on alternate days until the termination of treatment.
surgical
ACTIVE COMPARATORlesion extended excision
Interventions
Lesion extended excision with or without a random breast dermo-glandular flap (BDGF).
Eligibility Criteria
You may qualify if:
- Idiopathic Granulomatous Mastitis
You may not qualify if:
- Breast Carcinoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Breast Surgery,Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Related Publications (3)
Altintoprak F, Kivilcim T, Yalkin O, Uzunoglu Y, Kahyaoglu Z, Dilek ON. Topical Steroids Are Effective in the Treatment of Idiopathic Granulomatous Mastitis. World J Surg. 2015 Nov;39(11):2718-23. doi: 10.1007/s00268-015-3147-9.
PMID: 26148520BACKGROUNDSheybani F, Naderi HR, Gharib M, Sarvghad M, Mirfeizi Z. Idiopathic granulomatous mastitis: Long-discussed but yet-to-be-known. Autoimmunity. 2016 Jun;49(4):236-9. doi: 10.3109/08916934.2016.1138221. Epub 2016 Feb 1.
PMID: 26829298BACKGROUNDBenson JR, Dumitru D. Idiopathic granulomatous mastitis: presentation, investigation and management. Future Oncol. 2016 Jun;12(11):1381-94. doi: 10.2217/fon-2015-0038. Epub 2016 Apr 12.
PMID: 27067146BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Qiang Sun, master
Peking Union Medical College Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2016
First Posted
November 9, 2016
Study Start
January 1, 2017
Primary Completion
September 1, 2020
Study Completion
September 1, 2020
Last Updated
December 6, 2018
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will not share