| 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
|
|
|
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
|
|
|
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 |