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Comparison of three types of treatments in patients with Idiopathic Granulomatous Mastitis

Protocol summary

Study aim
Comparison of the type of new treatments for idiopathic granulomatous mastitis
Design
The double-blind randomized control trial
Settings and conduct
We decided to do a randomized, clinical trial for the most common treatments of this disease. We have located randomly the patients to one of the three treatment groups at the University Jihad, Breast Cancer Research Center and receive the informed consent form, and then follow them for 12 months, and ultimately respond to the treatment and side effects of the drug are compared in 3 groups. We will accurately record each patient's profile in a questionnaire. Laboratory and pathological characteristics are also evaluated in Kermanshah. Patients and researchers are also blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Female patients with Idiopathic Granulomatous Mastitis, age > 18 years Exclusion criteria: Patients with previous treatment, pregnant women, women without satisfaction; and women with infectious diseases and allergies
Intervention groups
Group 1: Some doctors believe that the disease does not need to be treated at a warm, red, and massive stage, but if it leads to an abscess, it will empty the abscess and give antibiotics. Group 2: A group of other doctors believes that the treatment of this disease is using corticosteroids such as prednisolone. In this group, the daily dose of 5mg / m2 decreases from dose to drug discontinuation. Group 3: In this group, prednisone is given high doses (4 mg / m2) twice a week, and rescue folic acid on days when the methotrexate tablet is not used for 18 months.
Main outcome variables
Response to treatment

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160101025791N3
Registration date: 2019-03-04, 1397/12/13
Registration timing: retrospective

Last update: 2019-03-04, 1397/12/13
Update count: 0
Registration date
2019-03-04, 1397/12/13
Registrant information
Name
Masoud Sadeghi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3842 5822
Email address
msadeghi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-28, 1397/08/06
Expected recruitment end date
2018-11-28, 1397/09/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of three types of treatments in patients with Idiopathic Granulomatous Mastitis
Public title
Treatments of Idiopathic Granulomatous Mastitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female patients Patients without systematic diseases
Exclusion criteria:
Pregnant women Women with a history of breast cancer in the family
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 150
More than 1 sample in each individual
Number of samples in each individual: 50
Group 1: Some doctors believe that the disease does not need to be treated at a warm, red, and massive stage, but if it leads to an abscess, it depletes the abscess and give antibiotics. Group 2: Because this is an autoimmune disease, another group of doctors believe that the treatment of this disease is using corticosteroids such as prednisolone. Group 3: Many patients can not continue prednisolone, and these patients use the combination of prednisolone and methotrexate.
Randomization (investigator's opinion)
Randomized
Randomization description
We is located four-piece papers (to the total number of patients) in a small box. On each paper, the number of each group has been written. The patient is asked to remove randomly one of the papers and read the number. The patient is not given any information about the type of treatments and the groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participant and Clinical Clinician (Physician) are kept blind. The study is double-blind. Participants are placed in each group respectively. The investigator (physician assistant) collects information. Researcher prepares the paper. The doctor evaluates the outcome.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kermanshah University of Medical Sciences
Street address
Vice – Chancellery of Research & Technology Affairs, building No.2, Shahid Beheshti Blvd., Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2018-10-10, 1397/07/18
Ethics committee reference number
IR.KUMS.REC.1397.564

Health conditions studied

1

Description of health condition studied
Idiopathic Granulomatous Mastitis
ICD-10 code
L92
ICD-10 code description
Granulomatous disorders of skin and subcutaneous tissue

Primary outcomes

1

Description
Response to treatment
Timepoint
Before and after 6 months of intervention
Method of measurement
ELISA kit

Secondary outcomes

1

Description
White blood cell
Timepoint
Before and after 6 months of intervention
Method of measurement
LeukoChek test kit

Intervention groups

1

Description
Group 1: Some doctors believe that the disease does not need to be treated at a warm, red, and massive stage, but if it leads to an abscess, it will empty the abscess and give antibiotics. This is the best remedy.
Category
Treatment - Drugs

2

Description
Group 2: Because of the autoimmune disease, another group of doctors believes that the treatment of this disease is using corticosteroids such as prednisolone. In this group, the daily dose of 5mg / m2 decreases from dose to drug discontinuation.
Category
Treatment - Drugs

3

Description
Group 3: Many patients can't continue prednisolone, they use prednisolone + immunosuppressants (such as methotrexate) in these patients. In this group, prednisone is given high doses (4 mg / m2) twice a week orally and rescue folic acid on days when the methotrexate tablet is not used for 18 months.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Motamed Cancer Institute
Full name of responsible person
Safa Najafi
Street address
No. 146, Southern Gandhi Early, Vanak Square, Tehran
City
Tehran
Province
Tehran
Postal code
1315795795
Phone
+98 83 3836 1773
Email
safa3n@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Vice-Chancellery of Research & Technology Affairs of Kermanshah University of Medical Science
Street address
Vice-Chancellery of Research & Technology Affairs, Building No.2, Shahid Beheshti Blvd., Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 5925
Email
farid_n32@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mazaher Ramezani
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Pathology
Street address
Nursing Blvd, Imam Reza Hospital, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714415333
Phone
+98 83 3427 6300
Email
Mazaher_ramezani@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mazaher Ramezani
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Pathology
Street address
Imam Reza Hospital, Nursing Blvd, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714415333
Phone
+98 83 3427 6300
Email
mazaher_ramezani@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Masoud Sadeghi
Position
Master of Science
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Nursing Blvd, Medical Biology Research Center
City
Kermanshah
Province
Kermanshah
Postal code
6714415185
Phone
+98 83 3427 6473
Email
sadeghi_mbrc@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Undecided - It is not yet known if there will be a plan to make this available
When the data will become available and for how long
Undecided - It is not yet known if there will be a plan to make this available
To whom data/document is available
Undecided - It is not yet known if there will be a plan to make this available
Under which criteria data/document could be used
Undecided - It is not yet known if there will be a plan to make this available
From where data/document is obtainable
Undecided - It is not yet known if there will be a plan to make this available
What processes are involved for a request to access data/document
Undecided - It is not yet known if there will be a plan to make this available
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