| CTRI Number |
CTRI/2026/02/103915 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
01/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Mixed method |
| Study Design |
Other |
|
Public Title of Study
|
Structured Treatment and Evaluation Pathway for Granulomatous Mastitis |
|
Scientific Title of Study
|
Development and Clinical Validation of Structured Evidence of Informed Clinical Pathway for Granulomatous Mastitis: A mixed method study |
| Trial Acronym |
STEP-GM |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gayatri Rangra |
| Designation |
Senior Resident |
| Affiliation |
AIIMS Delhi |
| Address |
Department of Surgical Disciplines
All India Institute of Medical Sciences(AIIMS)
New Delhi-110029
South
DELHI
110029
India |
| Phone |
9731837270 |
| Fax |
|
| Email |
g3rangra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suhani |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences(AIIMS) New Delhi |
| Address |
Department of Surgical Disciplines
All India Institute of Medical Sciences(AIIMS)
New Delhi-110029
South
DELHI
110029
India |
| Phone |
01126551816 |
| Fax |
|
| Email |
drsuhani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suhani |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences(AIIMS) New Delhi |
| Address |
Department of Surgical Disciplines
All India Institute of Medical Sciences(AIIMS)
New Delhi-110029
South
DELHI
110029
India |
| Phone |
01126551816 |
| Fax |
|
| Email |
drsuhani@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS DELHI, New Delhi-110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Delhi |
| Address |
All India Institute of Medical Sciences, Sri Aurobindo Marg, Ansari Nagar, New Delhi, Delhi 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gayatri Rangra |
AIIMS DELHI |
4th Floor, Department of Surgical Disciplines, AIIMS DELHI, Sri Aurobindo Marg, Ansari Nagar East, New Delhi, Delhi 110029
South West
DELHI |
9731837270
g3rangra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR PG RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N611||Abscess of the breast and nipple, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. Women above 18 years of age with clinical diagnosis of granulomatous mastitis.
2. Patients giving consent to enroll in the study. |
|
| ExclusionCriteria |
| Details |
1. Non-consenting females.
2. Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of patients with complete clinical response as defined by resolution of all clinical and radiologic signs of disease at 6 months |
3, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time to remission as measured by duration from start of treatment to appearance of complete response. |
3, 6 months |
| Patient-reported outcome measures for quality-of-life using pre-defined questionnaire |
0, 6 months |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is mixed method prospective Observational study to develop and validate a structured stepwise approach for management of granulomatous mastitis. This study will be carried out in the Department of Surgical Disciplines in collaboration with the Department of Pathology, Department of Radiodiagnosis and Department of Rheumatology at AIIMS, New Delhi. The study will be done in two phases. The first part involves participation of a multidisciplinary expert panel to build an evidence- informed diagnostic and treatment algorithm. for management of granulomatous mastitis. The second part of the study shall involve treatment of patients using the algorithm made in the first part. No new treatment modality will be used and the algorithm shall be created using an expert consensus on the existing literature. The response of the patient to various treatment modality used shall be noted in predefined proforma. The change in quality of life shall be studied using a predetermined questionnaire. |