| CTRI Number |
CTRI/2025/11/097441 [Registered on: 14/11/2025] Trial Registered Prospectively |
| Last Modified On: |
14/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Clinical profile of benign breast diseases in a tertiary care hospital in India |
|
Scientific Title of Study
|
Clinical, radiological and pathological profile of benign breast diseases in a tertiary care hospital: An Observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ankita Singh |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, Delhi |
| Address |
Room 411, 4th floor,Department of Surgical Disciplines, Surgery Block, AIIMS, Delhi
New Delhi
DELHI
110029
India |
| Phone |
9968633853 |
| Fax |
|
| Email |
ankitasingh05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ankita Singh |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, Delhi |
| Address |
Room 411, 4th floor,Department of Surgical Disciplines, Surgery Block, AIIMS, Delhi
DELHI
110029
India |
| Phone |
9968633853 |
| Fax |
|
| Email |
ankitasingh05@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ankita Singh |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, Delhi |
| Address |
Room 411, 4th floor,Department of Surgical Disciplines, Surgery Block, AIIMS, Delhi
DELHI
110029
India |
| Phone |
9968633853 |
| Fax |
|
| Email |
ankitasingh05@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Surgical Disciplines, All India Institute of Medical Sciences, Delhi, India -110029 |
|
|
Primary Sponsor
|
| Name |
ANKITA SINGH |
| Address |
Room 411, 4th floor, Department of Surgical Disciplines, Surgery Block, AIIMS, 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 Ankita Singh |
All India Institute of Medical Sciences, Delhi |
DEPARTMENT OF SURGICAL DISCIPLINES, SURGERY BLOCK, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, DELHI
New Delhi
DELHI |
9968633853
ankitasingh05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O911||Abscess of breast associated withpregnancy, the puerperium and lactation, (2) ICD-10 Condition: D249||Benign neoplasm of unspecified breast, (3) ICD-10 Condition: Q83||Congenital malformations of breast, (4) ICD-10 Condition: O921||Cracked nipple associated with pregnancy, the puerperium, and lactation, (5) ICD-10 Condition: O926||Galactorrhea, (6) ICD-10 Condition: O910||Infection of nipple associated with pregnancy, the puerperium and lactation, (7) ICD-10 Condition: L089||Local infection of the skin and subcutaneous tissue, unspecified, (8) ICD-10 Condition: O912||Nonpurulent mastitis associated with pregnancy, the puerperium and lactation, (9) ICD-10 Condition: O922||Other and unspecified disorders ofbreast associated with pregnancy and the puerperium, (10) ICD-10 Condition: O920||Retracted nipple associated with pregnancy, the puerperium, and lactation, (11) ICD-10 Condition: A188||Tuberculosis of other specified organs, |
|
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Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Female |
| Details |
Diagnosed clinically, radiologically and pathologically as a case of benign breast disease |
|
| ExclusionCriteria |
| Details |
Carcinoma co - existing in the same breast
Patient who was already treated for breast carcinoma
Patient having breast cancer in the contralateral breast
Co-existing BIRADS 4 and beyond lesions in the same breast
Patient with a history of prior Radiotherapy to breast/chest wall
|
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| To know the clinico radiological and clinico pathological profile of patients with benign breast diseases in a tertiary care center in India |
at baseline, 1 month, 6 months,12 months, 18 months, 24 months or resolution |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To know the clinical, radiological & pathological correlation in patients with benign breast diseases in a tertiary care center in India |
at baseline, 1 month, 6 months,12 months, 18 months, 24 months or resolution |
|
|
Target Sample Size
|
Total Sample Size="385"
Sample Size from India="385"
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)
|
25/11/2025 |
| 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="2"
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
|
The aim of this study is to study the clinical, pathological and radiological profile of patients with benign breast diseases from tertiary care center in India. This is a cross sectional observational study. |