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CTRI Number  CTRI/2025/08/092742 [Registered on: 11/08/2025] Trial Registered Prospectively
Last Modified On: 08/08/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Prospective analytic study 
Study Design  Single Arm Study 
Public Title of Study   To study lymph nodes by ultrasound of axilla before operation in breast cancer patients and to compare it with post operation results 
Scientific Title of Study   Preoperative Sonographic Features of Axillary Lymphnodes as Predictors of Malignant Involvement in Biopsy - Proven 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  Amilu Elsa Varghese  
Designation  Assistant Professor  
Affiliation  Govt medical college hospital Kottayam 
Address  Dept of Radiodiagnosis Govt medical college Kottayam Kerala

Kottayam
KERALA
686008
India 
Phone  9496334835  
Fax    
Email  amiluelsa@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Murali TV 
Designation  Assistant Professor Surgical oncology 
Affiliation  Govt Medcial College, Kottayam 
Address  Govt. Medical College, Kottayam. Surgical oncology.
gandhinagar, near casualty second floor ward
Kottayam
KERALA
686008
India 
Phone  9895658144  
Fax    
Email  surgoncktym@gmail.com  
 
Details of Contact Person
Public Query  
Name  Murali TV 
Designation  Assistant Professor Surgical oncology 
Affiliation  Govt Medcial College, Kottayam 
Address  Govt. Medical College, Kottayam. Surgical oncology.
gandhinagar, near casualty second floor ward
Kottayam
KERALA
686008
India 
Phone  9895658144  
Fax    
Email  surgoncktym@gmail.com  
 
Source of Monetary or Material Support  
Govt Medical college Kottayam  
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [Nil] 
 
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 
Dr Amilu Elsa Varghese   Govt Medical College Kottayam  Room No 101, Lower Ground floor, New surgical block Govt Medical College Kottayam 686008
Kottayam
KERALA 		 9496334835

amiluelsa@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
InstitutionalReviewBoardGovtMedicalCollegeKottyam  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C50||Malignant neoplasm of breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
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  invasive breast cancer diagnosed in pathology
No chemotherapy received prior to axillary staging procedure. 
 
ExclusionCriteria 
Details  Phyllodes , sarcoma breast , insitu disease only , are excluded 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Ultrasound features predicting malignancy with final histopathology as gold standard  Presurgery assessment
Post surgery pathology review at 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   28/08/2025 
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="3"
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  
Introduction 
In our hospital’s surgical oncology department, the practice regarding addressing the axilla in breast cancer is to go through a tumour board. For patients planned for upfront surgery and not anterior chemotheapy by the tumour board, broadly clinicoradiologically axilla negative patients receive Sentinel node biopsy ( SLNB)and those who are clinically or radiologically axillary lymph node positive will receive an axillary dissection. 
This research was thought of as to determine which imaging characteristics of axillary lymph nodes should be considered as high chance of being metastatic to decide on if SLNB or axillary dissection should be performed upfront. 

Materials and Methods

All patients with biopsy-proven invasive breast cancer who are decided for upfront surgery in the tumour board are considered for the study.  Written informed consent in the regional language was obtained from each patient regarding enrollment in the study.  An axillary ultrasound is done a day prior to surgery for all consented patients. The ultrasound features are documented in profomas. Surgery is completed, and the axilla is addressed in the existing manner of the hospital.  A clinicoradiological negative axilla undergoes SLNB, and a positive one axillary dissection. 

After the trial,  final histopathology is correlated with the ultrasound characteristics to see which are the best predictive USG characteristics in nodal involvement of breast cancer.

 
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