| CTRI Number |
CTRI/2019/05/018939 [Registered on: 03/05/2019] Trial Registered Prospectively |
| Last Modified On: |
25/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Diagnostic Prospective Cross sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to compare two methods used in diagnosis of various breast lesions namely Fine needle aspiration Cytology and core needle biopsy. |
|
Scientific Title of Study
|
A Prospective Comparative Study Between Fine Needle Aspiration Cytology(FNAC) and Trucut Biopsy in Diagnosis of Palpable Breast Lumps |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nilkanth M Suthar |
| Designation |
First year resident, General surgery |
| Affiliation |
Government medical college, Bhavnagar |
| Address |
Department of General Surgery,Sir T Hospital, Jail Road, Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
8758857850 |
| Fax |
|
| Email |
nilkanth.suthar17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Samir M Shah |
| Designation |
Professor and Head, General Surgery |
| Affiliation |
Government medical college & Sir T Hospital, Bhavnagar |
| Address |
Department of General Surgery,Sir T Hospital, Jail Road, Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
|
| Fax |
|
| Email |
shah.samir@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nilkanth M Suthar |
| Designation |
First year Resident,Department of General Surgery |
| Affiliation |
Government medical college & Sir T Hospital, Bhavnagar |
| Address |
Department of General Surgery,Sir T Hospital, Jail Road, Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
|
| Fax |
|
| Email |
nilkanth.suthar17@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of General Surgery, Sir T Hospital, Bhavnagar, Gujarat-364001 |
|
|
Primary Sponsor
|
| Name |
Department of General Surgery |
| Address |
Department of General Surgery, Sir T Hospital, Bhavnagar, Gujarat-364001 |
| 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 Nilkanth M Suthar |
Sir T Hospital |
Department of General Surgery, Sir T Hospital
Bhavnagar
GUJARAT |
8758857850
nilkanth.suthar17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board, GMC, Bhavnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N60-N65||Disorders of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Female |
| Details |
All the female patients of age between 18 and 85 year with clinically palpable breast lumps |
|
| ExclusionCriteria |
| Details |
Male patients,Female patients below 18 year and above 85 year age |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| N/a |
n/a |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/a |
n/a |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
05/05/2019 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
1.Fine needle aspiration cytology versus trucut biopsy in the diagnosis of breast cancer: a comparative study International Surgery Journal Shashirekha CA et al. Int Surg J. 2017 Nov;4(11):3718-3721; http://www.ijsurgery.com
2.Comparitive study between FNAC and TCNB for diagnosis of breast masses : https://www.researchgate.net/publicat i on/259829379
3.A Comparison of Aspiration Cytology and Core Needle Biopsy in the Evaluation of Breast Lesions: Received June 28, 2000; revision received November 30, 2000; accepted December 6, 2000
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In this Diagnostic Study, we compare two commonly used method - Fine needle aspiration cytology and Trucut biopsy with the gold standard method - histopathological result of excised specimen, in terms of Diagnostic accuracy, Sensitivity, Specificity. positive and negative predictive values, time of availability of results and various complications. |