| CTRI Number |
CTRI/2026/02/103365 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
08/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Diagnostic |
| Study Design |
Other |
|
Public Title of Study
|
Vimentin: A Key Protein Studied in Young Women with Triple Negative Breast Cancer to Understand How Aggressive the Disease Is |
|
Scientific Title of Study
|
Immunochistochemical evaluation of Vimentin in triple negative breast carcinoma in young females with its relation to other clinicopathological parameters |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MUSKAAN BHATNAGAR |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
JNMC WARDHA |
| Address |
DEPARTMENT OF PATHOLOGY, JAWAHARLAL NEHRU MEDICAL COLLEGE DATTA MEGHE SAWANGI WARDHA
Wardha
MAHARASHTRA
442001
India |
| Phone |
09644094484 |
| Fax |
|
| Email |
muski7698@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PRAVIN GADKARI |
| Designation |
HEAD OF THE DEPARTMENT AND GUIDE |
| Affiliation |
JNMC WARDHA |
| Address |
DEPARTMENT OF PATHOLOGY, JAWAHARLAL NEHRU MEDICAL COLLEGE DATTA MEGHE SAWANGI WARDHA
Wardha
MAHARASHTRA
442001
India |
| Phone |
9373101668 |
| Fax |
|
| Email |
prg835@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MUSKAAN BHATNAGAR |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
JNMC WARDHA |
| Address |
DEPARTMENT OF PATHOLOGY, JAWAHARLAL NEHRU MEDICAL COLLEGE DATTA MEGHE SAWANGI WARDHA
Wardha
MAHARASHTRA
442001
India |
| Phone |
09644094484 |
| Fax |
|
| Email |
muski7698@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
MUSKAAN BHATNAGAR |
| Address |
JAWAHRLAL NEHRU MEDICAL COLLEGE SAWANGI WARDHA MAHARASHTRA INDIA 442001 |
| 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 |
| Dr Muskaan Bhatnagar |
Jawaharlal Nehru Medical College & Acharya Vinoba Bhave Rural Hospital (AVBRH) |
Histopath lab Pathology department AVBRH hospital Sawangi Meghe Wardha 442001 Maharashtra India
Wardha
MAHARASHTRA |
09644094484
muski7698@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education & Research (DMIMER-DU) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Resected specimens of Invasive ductal carcinoma confirmed on histopathology.
Molecular subtype of TNBC confirmed on IHC. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the frequency of vimentin positivity and its expression levels in TNBC cases in females under 50 years using immunohistochemistry. |
At baseline four weeks to 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation of vimentin expression with clinicopathological parameters including tumor size, grade, lymphovascular invasion, lymph node status, and stage. |
At baseline. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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="5"
Months="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 aims to evaluate the immunohistochemical expression of vimentin in triple-negative breast carcinoma in females below 50 years of age and to assess its association with clinicopathological parameters. TNBC is an aggressive subtype of breast cancer commonly affecting younger women and lacks targeted therapeutic options. Vimentin, a mesenchymal marker involved in epithelial–mesenchymal transition, has been associated with tumor aggressiveness and poor prognosis in breast carcinoma. This is a retrospective and prospective observational diagnostic study conducted in the Department of Pathology at a tertiary care center. Formalin-fixed paraffin-embedded resected specimens of TNBC will be evaluated using immunohistochemistry for vimentin expression. The frequency and pattern of vimentin expression will be assessed and correlated with tumor size, histological grade, lymphovascular invasion, lymph node status, and tumor stage. The study aims to determine whether vimentin expression can serve as a useful prognostic biomarker in young patients with TNBC and contribute to better risk stratification in this high-risk group.
|