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CTRI Number  CTRI/2026/01/102214 [Registered on: 28/01/2026] Trial Registered Prospectively
Last Modified On: 27/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study to understand nipple area involvement in women with breast cancer. 
Scientific Title of Study   To determine the involvement of nipple areolar complex in breast cancer and to find out pre operative predictors for involvement of Nipple areolar complex in breast cancer 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Navdeep Kaur Lubana 
Designation  Junior Resident  
Affiliation  Dr Rajendra Prasad Government 
Address  Department of General Surgery, Dr Rajendra Prasad Government Medical College, Tanda, Kangra, Himachal Pradesh

Kangra
HIMACHAL PRADESH
176001
India 
Phone  7986871373  
Fax    
Email  nknavdeepakaurl08@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sanjeev Kumar 
Designation  Professor and Head of Department  
Affiliation  Dr Rajendra Prasad Government 
Address  Department of General Surgery, Dr Rajendra Prasad Government Medical College, Tanda, Kangra, Himachal Pradesh

Kangra
HIMACHAL PRADESH
176001
India 
Phone  9418158199  
Fax    
Email  hodsurgery@rpgmc.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Sanjeev Kumar 
Designation  Professor and Head of Department  
Affiliation  Dr Rajendra Prasad Government 
Address  Department of General Surgery, Dr Rajendra Prasad Government Medical College, Tanda, Kangra, Himachal Pradesh


HIMACHAL PRADESH
176001
India 
Phone  9418158199  
Fax    
Email  hodsurgery@rpgmc.ac.in  
 
Source of Monetary or Material Support  
Dr Rajendra Prasad Government Medical College, Tanda, Kangra, Himachal Pradesh, India, 176001 
 
Primary Sponsor  
Name  Dr Navdeep Kaur Lubana 
Address  Dr Rajendra Prasad Government Medical College, Tanda, Kangra, Himachal Pradesh, India. Pin 176001 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Navdeep Kaur Lubana  Dr Rajendra Prasad Government Medical College  Female Surgery Ward 1, Third Floor, Department Of General surgery, Clinical Block
Kangra
HIMACHAL PRADESH 
7986871373

nknavdeepakaurl08@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr Rajendra Prasad Government Medical College(Dr. RPGMC) Kangra at Tanda, Himachal Pradesh, India - 176001  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C500||Malignant neoplasm of nipple and areola,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Female 
Details  1. Patients must have malignant breast lesions.
2. Patients must consent to take part in the study. 
 
ExclusionCriteria 
Details  Patients who do not provide informed consent to participate in the study.
Patients with Paget’s disease of the breast.
Patients diagnosed with benign breast lesions.
Patients with recurrent breast cancer.
Patients who have received prior radiotherapy to the breast.
Patients who are medically unfit to undergo surgery. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the involvement of nipple areolar complex in breast cancer and to find out predictors of nipple areolar complex involvement in Breast Cancer   2 week after mastectomy 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the involvement of nipple areolar complex in malignant Breast Cancer  2 week after mastectomy 
To find out predictors of nipple areolar complex involvement in breast cancer like tumor size, location, distance of tumor from NAC, tumor depth, BIRADS category, Receptor status  2 week after mastectomy 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   13/02/2026 
Date of Study Completion (India) 31/03/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

Breast cancer is one of the most common cancers affecting women. During surgery for breast cancer, the nipple and surrounding dark area (called the nipple area) may sometimes need to be removed if it is affected by cancer. However, in many patients, this nipple area may not be involved, and preserving it can improve cosmetic appearance and body image after surgery.

The challenge for doctors is to accurately identify, before surgery, which patients have cancer involvement of the nipple area and which do not. At present, this decision is often made during or after surgery, which may lead to unnecessary removal of the nipple area in some patients.

This study aims to find out how often the nipple area is affected in patients with breast cancer and to identify factors that can help predict this involvement before surgery. These factors may include patient symptoms, findings on breast examination, imaging tests such as mammography or ultrasound, and tumour characteristics.

By identifying reliable preoperative indicators, this study may help surgeons better plan breast cancer surgery and safely preserve the nipple area in suitable patients. This could lead to improved cosmetic outcomes without compromising cancer treatment, ultimately improving patient satisfaction and quality of life.

 
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