| CTRI Number |
CTRI/2025/08/093065 [Registered on: 14/08/2025] Trial Registered Prospectively |
| Last Modified On: |
14/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
vacuum assisted biopsy to see response after chemotherapy in breast cancer. |
|
Scientific Title of Study
|
To assess the accuracy of vacuum assisted biopsy (VAB)to determine the pathological complete response following NACT in
breast cancer patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ayush Khajuria |
| Designation |
Junior resident |
| Affiliation |
AIIMS delhi |
| Address |
Dr BRAIRCH Building, 1st Flooir Room 160-B IRCH AIIMS DELHI
South
DELHI
110029
India |
| Phone |
7006238315 |
| Fax |
|
| Email |
ayushaiimsd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr krithika Rangarajan |
| Designation |
Associate Professor |
| Affiliation |
AIIMS delhi |
| Address |
Dr BRAIRCH Building, 1st Floor Room 160-B IRCH AIIMS DELHI
South West
DELHI
110029
India |
| Phone |
01129575064 |
| Fax |
|
| Email |
krithikarangarajan@aiims.edu |
|
Details of Contact Person
Public Query
|
| Name |
Ayush Khajuria |
| Designation |
Junior resident |
| Affiliation |
AIIMS delhi |
| Address |
Dr BRAIRCH Building, 1st Flooir Room 160-B IRCH AIIMS DELHI
South
DELHI
110029
India |
| Phone |
7006238315 |
| Fax |
|
| Email |
ayushaiimsd@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institiute of Medical Science, New Delhi-110029
Dr.BRAIRCH,Radiodiagnosis Department |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
None |
| Type of Sponsor |
Other [Nill] |
|
|
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 |
| Ayush khajuria |
AIl India Institute of Medical Sciences Delhi |
Room 160B IRCH, AIIMS Delhi
South West
DELHI |
7006238315
ayushaiimsd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Instituite of Medical Science |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard surgical procedure |
standard surgical procedure will be performed as per surgeons discretion. |
| Intervention |
Vaccum assisted biopsy |
USG guided biopsy prior to surgery. 2 weeks post surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1.female patients more than 18 years old
2.patients having T1,T2& T3 with N0 breast cancer having complete response on contrast enhanced mammography following chemotherapy.
3.patients having unifocal disease prior to chemotherapy
4.patients in whom breast localization clip has been placed. |
|
| ExclusionCriteria |
| Details |
1.Patients having clinical or radiological positive lymph node status.
2.patients having extensive microcalcification on initial mammography
3.patients having multifocal or multicentric breast cancer
4.patients in which position of clip is too far posterior or too superficial thus making it difficult to complete VAB |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| concordance of vab pathology with surgical histopathology. |
Two weeks post surgery |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
26/08/2025 |
| 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 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 is aimed to correlate the results of Vacuum assisted biopsy showing pathological complete response after chemotherapy with final surgical histopathology.
|