Evaluate FNAC of breast lesions using Yokohama classification and its correlation with BIRAD System

Not yet recruiting

Conditions: 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,

Registration Number: CTRI/2023/04/051241

Lead Sponsor: BPS GMC(W), Khanpur Kalan, Sonepat

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

All the patients having breast lump whose both FNAC and BIRADS grading will be done.

Exclusion Criteria

Patients with ulcerative lesion or skin involvement.
Patients with history of chemotherapy and radiotherapy.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate FNAC of breast lesions using Yokohama classification and its correlation with the BIRAD system.	6 months, 1 year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1): BPS GMC(W), Khanpur Kalan, Sonepat
🇮🇳
Sonipat, HARYANA, India
BPS GMC(W), Khanpur Kalan, Sonepat
🇮🇳Sonipat, HARYANA, India
Dr Vishal
Principal investigator
9991665417
vishalrohilla.3696@gmail.com