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
|
|
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
|
|
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
|
|
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. |