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CTRI Number  CTRI/2025/09/095079 [Registered on: 19/09/2025] Trial Registered Prospectively
Last Modified On: 19/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   How the Yokohama System Helps in Diagnosing Breast Lesions through Cytology 
Scientific Title of Study   Diagnostic utility of the Yokohama system in reporting cytology of breast lesions 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Gaurav Soni 
Designation  PG Student 
Affiliation  Datta Meghe Institute of Higher Education & Research (DMIHER) 
Address  Department of Pathology, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education & Research(DMIHER), Sawangi (Meghe)

Wardha
MAHARASHTRA
442001
India 
Phone  9075388459  
Fax    
Email  gsgauravsoni31@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Anil Agrawal 
Designation  Professor 
Affiliation  Datta Meghe Institute of Higher Education & Research (DMIHER) 
Address  Department of Pathology, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education & Research(DMIHER) Sawangi(Meghe) Wardha, Maharashtra

Wardha
MAHARASHTRA
442001
India 
Phone  9850309278  
Fax    
Email  dranilagrawal.456@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Gaurav Soni 
Designation  PG Student 
Affiliation  Datta Meghe Institute of Higher Education & Research (DMIHER) 
Address  Department of Pathology, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education & Research (DMIHER), Sawangi (Meghe)

Wardha
MAHARASHTRA
442001
India 
Phone  9075388459  
Fax    
Email  gsgauravsoni31@gmail.com  
 
Source of Monetary or Material Support  
Datta Meghe Institute of Higher Education & Research (DMIHER), Sawangi (Meghe), Wardha, Maharashtra 442001 
 
Primary Sponsor  
Name  Datta Meghe Institute of Higher Education & Research (DMIHER) 
Address  Datta Meghe Institute of Higher Education & Research (DMIHER), Sawangi (Meghe), Wardha, Maharashtra 442001 
Type of Sponsor  Research institution and hospital 
 
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 Gaurav Soni  Acharya Vinoba Bhave Rural Hospital Campus  Department of Pathology, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education & Research (DMIHER), Sawangi (Meghe)
Wardha
MAHARASHTRA 
09075388459

gsgauravsoni31@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe Instituteof Higher Educationand Research(Deemed to beUniversity)InstitutionalEthics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D24||Benign neoplasm of breast, (2) ICD-10 Condition: C50||Malignant neoplasm of breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  1. All the female patients presenting with palpable breast lumps. 
 
ExclusionCriteria 
Details  1. All the patients already diagnosed as breast carcinoma.
2. All the operated cases of breast carcinoma.
3. All patients with breast carcinoma which is arising as a result of recurrence.
4. All the patients not willing for participation in the study and males. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Diagnostic accuracy of Yokohama system in differentiating benign and malignant breast lesions.  2 years 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="131"
Sample Size from India="131" 
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)   20/06/2026 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Background

Breast lesions are considerably more common in females than in males and most frequently present as palpable lumps. Histopathological analysis indicates fibrocystic change as the predominant finding followed by cases without significant pathology miscellaneous benign lesions and fibroadenoma. Broadly breast lesions are classified into benign and malignant categories. Among malignant lesions breast carcinoma remains the leading cancer in Indian women with an estimated incidence of 26 per 100000 and a mortality rate of 13 per 100000 women. According to GLOBOCAN 2024 breast cancer accounts for 135 percent of all cancers and 106 percent of cancer related deaths in India with a cumulative lifetime risk of 281 percent. Given its position as the most common malignancy in women globally as well as nationally early detection and diagnosis of palpable breast lumps are essential for timely initiation of appropriate therapy.

Fine needle aspiration cytology FNAC has become a frontline diagnostic modality owing to its simplicity cost effectiveness and minimally invasive nature. Conducted in the outpatient setting FNAC when combined with clinical and radiological assessment allows efficient triaging of breast lesions reducing the need for invasive diagnostic procedures without delaying treatment in malignant cases. Its utility is especially significant in resource limited settings. Additionally aspirated material can be processed into cell blocks enabling ancillary studies and expanding diagnostic accuracy.

To establish uniformity in reporting the International Academy of Cytology IAC introduced the Yokohama System in 2016. Developed through collaboration between cytopathologists surgeons oncologists and radiologists this standardized five tier classification links cytological categories with their corresponding risk of malignancy ROM and clinical management pathways. The categories include insufficientinadequate benign atypical suspicious of malignancy and malignant. By providing consistent terminology and aligning reporting with management algorithms the Yokohama system enhances diagnostic reproducibility improves interdisciplinary communication and supports optimal patient care.

Methodology

This is a laboratory based prospective observational study proposed for two years November 2023 to November 2025 in the Histopathology and Immunohistochemistry division of the Department of Pathology Jawaharlal Nehru Medical College Sawangi Meghe in collaboration with the Department of General Surgery Acharya Vinoba Bhave Rural Hospital Sawangi Meghe. Institutional Ethics Committee approval will be obtained prior to commencement and informed consent will be secured from all participants.

Conclusion

All breast FNA smears will be evaluated and reported using the IAC Yokohama system as follows

Category 1 Inadequate eg blood only non representative material
Category 2 Benign eg fibroadenoma breast abscess
Category 3 Atypical presence of atypical cells
Category 4 Suspicious of malignancy
Category 5 Malignant


 
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