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Medical and Surgical Treatment for Idiopathic Granulomatous Mastitis (MSTIGM)

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ClinicalTrials.gov Identifier: NCT02959580
Recruitment Status : Recruiting
First Posted : November 9, 2016
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

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.

Condition or disease Intervention/treatment Phase
Granulomatous Mastitis Drug: Hydrocortisone Butyrate Procedure: extended excision Phase 4

Detailed Description:

Idiopathic granulomatous mastitis (IGM) is a rare benign inflammatory breast disease of unknown etiology.It may present with many findings that clinically and radiologically mimic breast cancer.

Although IGM as a disease has been known for nearly four decades, the optimal treatment approach has not been established. Surgical intervention in the form of wide surgical excision was the mainstay of treatment before 1980, and is still performed depending on local expertise and preference.

Currently,surgical treatment and systemic steroid treatment are frequently employed. With the consideration of side effects of longterm systemic (oral) steroid usage, topical steroid without systemic use were assessed and showed satisfactory curative effect. But the data concerning the use of topical steroid therapy are still very limited.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Topical Steroids and Surgical Treatment for Idiopathic Granulomatous Mastitis
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Diseases

Arm Intervention/treatment
Experimental: medical
Hydrocortisone butyrate cream(0.1%) was applied to the breast by the patient twice a day on alternate days until the termination of treatment.
Drug: Hydrocortisone Butyrate
topical use

Active Comparator: surgical
lesion extended excision
Procedure: extended excision
Lesion extended excision with or without a random breast dermo-glandular flap (BDGF).




Primary Outcome Measures :
  1. clinical response rate [ Time Frame: six months ]
    The clinical response is categorized into ''completely healed,'' ''inadequately healed,'' ''stable,'' ''worsened,'' or ''relapsed'' if the lesions had once healed but symptoms returned.


Secondary Outcome Measures :
  1. granulomatous mastitis recurrence [ Time Frame: two years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Idiopathic Granulomatous Mastitis

Exclusion Criteria:

  • Breast Carcinoma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02959580


Contacts
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Contact: Yanna Zhang, M.D. 86-10-69158703 pumchzyn@sohu.com

Locations
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China, Beijing
Department of Breast Surgery,Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Qiang Sun, Master    86-010-69158720    sunqiangpumc@sina.com   
Contact: Yanna Zhang, Doctor    86-010-69158703    pumchzyn@sohu.com   
Principal Investigator: Qiang Sun, Master         
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Principal Investigator: Qiang Sun, master Peking Union Medical College Hospital

Publications:
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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT02959580    
Other Study ID Numbers: PUMCH-breast-mastitis
First Posted: November 9, 2016    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Peking Union Medical College Hospital:
Granulomatous
Mastitis
topical steroids
Additional relevant MeSH terms:
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Mastitis
Granulomatous Mastitis
Puerperal Disorders
Pregnancy Complications
Breast Diseases
Skin Diseases
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Dermatologic Agents