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CTRI Number  CTRI/2023/04/051241 [Registered on: 03/04/2023] Trial Registered Prospectively
Last Modified On: 28/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Evaluate FNAC of breast lesions using Yokohama classification and its correlation with BIRAD System 
Scientific Title of Study   Categorisation of breast fine needle aspirates using Yokohama classification and its correlation with BIRAD system 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vishal 
Designation  PG Resident 
Affiliation  BPS GMC(W), Khanpur Kalan, Sonepat 
Address  Department of Pathology, BPS GMC(W), Khanpur Kalan, Sonepat
Department of Pathology, BPS GMC(W), Khanpur Kalan, Sonepat
Sonipat
HARYANA
131305
India 
Phone  9991665417  
Fax    
Email  vishalrohilla.3696@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Parveen Rana Kundu 
Designation  Professor 
Affiliation  BPS GMC(W), Khanpur Kalan, Sonepat 
Address  Department of Pathology, BPS GMC(W), Khanpur Kalan, Sonepat
Department of Pathology, BPS GMC(W), Khanpur Kalan, Sonepat
Sonipat
HARYANA
131305
India 
Phone  9896211426  
Fax    
Email  kunduparveen2018@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vishal 
Designation  PG Resident 
Affiliation  BPS GMC(W), Khanpur Kalan, Sonepat 
Address  Department of Pathology, BPS GMC(W), Khanpur Kalan, Sonepat
Department of Pathology, BPS GMC(W), Khanpur Kalan, Sonepat
Sonipat
HARYANA
131305
India 
Phone  9991665417  
Fax    
Email  vishalrohilla.3696@gmail.com  
 
Source of Monetary or Material Support  
Department Of Patholgy, BPS GMC(W), Khanpur Kalan, Sonepat 
 
Primary Sponsor  
Name  BPS GMC(W), Khanpur Kalan, Sonepat 
Address  BPS GMC(W), Khanpur Kalan, Sonepat 
Type of Sponsor  Government medical college 
 
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 Vishal  BPS GMC(W), Khanpur Kalan, Sonepat  Department of Pathology, BPS GMC(W), Khanpur Kalan, Sonepat, Haryana
Sonipat
HARYANA 
9991665417

vishalrohilla.3696@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D249||Benign neoplasm of unspecified breast, (2) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, (3) ICD-10 Condition: N609||Unspecified benign mammary dysplasia, (4) ICD-10 Condition: N630||Unspecified lump in unspecified breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  All the patients having breast lump whose both FNAC and BIRADS grading will be done 
 
ExclusionCriteria 
Details  1. Patients with ulcerative lesion or skin involvement.
2. Patients with history of chemotherapy and radiotherapy.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate FNAC of breast lesions using Yokohama classification and its correlation with the BIRAD system.  6 months, 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
1. To categorise FNAC smears of breast lump according to Yokohama system.
2. To categorise the ultrasound findings of breast lump using USG based BIRAD
system.
3. To find concordance between Yokohama system and USG based BIRAD system for reporting breast lesions.
 
6 months, 1 year 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   08/04/2023 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Breast cancer is the most common cause of cancer in women globally. It has now surpassed lung cancer which was previously the first cause of cancer incidence globally. In India, breast cancer is ranked number one overall and among females. The FNAC Yokohama reporting system and BIRADS scoring system are good methods to detect any breast abnormality. Both in conjucation aid in identifying prognostically relavant diagnostic categories and thereby helping in multidisplinary management of breast lesions. This study will substantiate the role of FNAC and utility of IAC Yokhama in evaluation of breast lesions. We are doing this study to evaluate FNAC of breast lesions using Yokohama classification and its correlation with BIRAD System. Patient having breast lump clinically and who underwent FNAC and ultrasonography will be included after obtaining informed written consent. Patient confidentiality will be ensured by deidentifying data and patient will be given a unique code in numbers. Other relevant history, clinical findings will be collected from requisition form. The breast lump will be reported on USG according to BIRADS categories as suggested by American College of Radiology (ACR) and known as ACR BIRADS.

All cytology smears of FNAC will be examined in detail initially by postgraduate student and later will be reviewed by supervisor and co-supervisor pathologists. Cytology will be reported according to the IAC Yokohama System 2016. The collected data will be entered in Microsoft excel spread sheet. Mean and standard deviation will be calculated for a quantitative data. Percentage and proportion will be calculated for qualitative data. Chi square test will be used to find out the association and kappa statistic will be used to find the agreement between FNAC and USG using SPSS 20 software. A p value <0.05 will be considered as statistically significant. 
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