| 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
|
|
|
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
|
|
|
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. |