| CTRI Number |
CTRI/2024/02/063238 [Registered on: 28/02/2024] Trial Registered Prospectively |
| Last Modified On: |
27/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Using GATA-3 and KRT 5/6 IHC markers for molecular phenotyping of bladder carcinoma. |
|
Scientific Title of Study
|
Using GATA-3 and KRT 5/6 IHC markers for molecular phenotyping of bladder carcinoma: A Cross sectional study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mehnaz Munawar |
| Designation |
Junior Resident |
| Affiliation |
Rohilkhand medical college and hospital |
| Address |
Room no 1162, Histology division,Department of Pathology, Rohilkhand medical college and hospital, Bareilly.
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9149881969 |
| Fax |
|
| Email |
mehnaaz.mir03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nitesh Mohan |
| Designation |
Professor and head of Department |
| Affiliation |
Rohilkhand medical college and hospital |
| Address |
Room no. 1165, Department of Pathology, Rohilkhand medical college and hospital, Bareilly.
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9997872559 |
| Fax |
|
| Email |
drnitesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mehnaz Munawar |
| Designation |
Junior Resident |
| Affiliation |
Rohilkhand medical college and hospital |
| Address |
Room no 1162,Department of Pathology, Rohilkhand medical college and hospital, Bareilly.
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9149881969 |
| Fax |
|
| Email |
mehnaaz.mir03@gmail.com |
|
|
Source of Monetary or Material Support
|
| ROHILKHAND MEDICAL COLLEGE AND HOSPITAL |
|
|
Primary Sponsor
|
| Name |
ROHILKHAND MEDICAL COLLEGE |
| Address |
Rohilkhand Medical College and Hospital, Pilibhit Bypass Road, Opp. Suresh Sharma Nagar, Bareilly. |
| Type of Sponsor |
Private 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 Mehnaz Munawar |
Rohilkhand Medical College and Hospital |
Room no 1162, Histology lab, Department of pathology,Rohilkhand Medical College and Hospital, Pilibhit Bypass Road, Bareilly
Bareilly
UTTAR PRADESH |
9149881969
mehnaaz.mir03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMITTEE, RMCH, Bareilly, U.P |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C679||Malignant neoplasm of bladder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All histopathologically confirmed cases of bladder carcinoma that will be received in our department. |
|
| ExclusionCriteria |
| Details |
The biopsy reported as unsatisfactory and patients who are not willing to give consent. Tissue is insufficient for reporting. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the immunohistochemical expression of GATA-3 and KRT 5/6 in all histologically confirmed cases of urinary bladder carcinoma and categorise them in basal and luminal phenotypes accordingly. |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="61"
Sample Size from India="61"
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)
|
10/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/03/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study will be conducted in the Department of Pathology Rohilkhand Medical College and Hospital, Bareilly after obtaining approval from the Institutional Ethics Committee and will include all urinary bladder biopsy specimens received in the department in a one-year duration. The received formalin-fixed biopsy specimens will be subjected to gross and microscopic examination as per standard protocol. Haematoxylin and Eosin stains will be used to stain the previously cut paraffin-embedded tissues (4-5 microns). Sections will be deparaffinized for immunohistochemistry, and Heat-Induced Epitome Retrieval (HIER) will be carried out using an EDTA buffer. Tissue slices will be incubated with ready-to-use antibodies against IHC markers at a dilution of 1:100.
A 3,3’-diaminobenzene (DAB) detection kit, a hydrogen peroxide substrate, and a DAB chromogen will be utilized for the detection process. A DAB chromogen will be used to evaluate the markers’ antibody staining. On IHC stained slides, observations will be taken and recorded. In this study, the immunohistochemical markers GATA 3 and KRT 5/6 will be used. IMMUNOHISTOCHEMICAL ANALYSIS: The prepared slides will be examined for positive or negative immunostaining using an optical microscope at x400 magnification.
STATISTICAL ANALYSIS: Data will be entered in SPSS (Statistical Package for social sciences); licensed version 23.0. Descriptive analysis will be done by calculating proportions, means and standard deviation. Appropriate statistical tests will be applied depending on the type and distribution of data. p <0.05 will be considered significant |