| CTRI Number |
CTRI/2024/02/063123 [Registered on: 23/02/2024] Trial Registered Prospectively |
| Last Modified On: |
20/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Role of IHC markers in oral cancer |
|
Scientific Title of Study
|
Correlation of E-Cadherin and Cyclin D1 expression with histomorphological features in Oral Squamous Cell 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 |
DrShilpi Singh |
| Designation |
Junior resident |
| Affiliation |
Rohilkhand Medical College and Hospital |
| Address |
Department of Pathology Room no 1162 Rohilkhand Medical College and Hospital Pawan Vihar
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9999360261 |
| Fax |
|
| Email |
Shilpisingh066@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nitesh Mohan |
| Designation |
Professor and HOD |
| Affiliation |
Rohilkhand Medical College and Hospital |
| Address |
Room no 1164 Department of Pathology Rohilkhand Medical College and Hospital Pawan Vihar
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9997872559 |
| Fax |
|
| Email |
drnitesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrShilpi Singh |
| Designation |
Junior resident |
| Affiliation |
Rohilkhand medical college and hospital |
| Address |
Room no 1 Ground Floor Girls Hostel No.2 Rohilkhand Medical College and Hospital Pawan Vihar
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9999360261 |
| Fax |
|
| Email |
shilpisingh066@gmail.com |
|
|
Source of Monetary or Material Support
|
| Histopathology lab, Rohilkhand medical college and hospital |
|
|
Primary Sponsor
|
| Name |
Dr. Shilpi Singh |
| Address |
Room no. 1 Girls Hostel no.2 Rohilkhand Medical College and Hospital |
| Type of Sponsor |
Other [Self] |
|
|
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 Shilpi Singh |
Rohilkhand Medical College and Hospital |
Department of pathology Rohilkhand Medical College and Hospital Pawan Vihar
Bareilly
UTTAR PRADESH |
9999360261
Shilpisingh066@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, RMCH, Bareilly, U.P |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All biopsy cases from oral cavity diagnosed histopathologically as Squamous Cell Carcinoma during study period |
|
| ExclusionCriteria |
| Details |
Cancers of oral cavity other than Squamous cell carcinoma
Inadequate biopsy specimens |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate histomorphological findings of oral squamous cell carcinoma
To determine E-Cadherine and Cyclin D1 immunohistochemical markers expression in oral squamous cell carcinoma
To correlate immunohistochemical expression with histomorphological findings in these cases |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate histomorphological findings of oral squamous cell carcinoma
To determine E-Cadherine & Cyclin D1 immunohistochemical markers expression in oral squamous cell carcinoma
To correlate immunohistochemical expression with histomorphological findings in these cases |
Monthly |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
29/02/2024 |
| 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 Yet Recruiting |
| 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 Department of Pathology, Rohilkhand Medical College
and Hospital, Bareilly after taking approval from Institutional Ethics Committee
and consent from patient and will include all oral biopsy specimens received in the
department during the study period.
The received specimen will be subjected to gross and microscopic examination as per
standard protocol.
Paraffin embedded tissues (4-5 micron) will be cut stained by Haematoxylin and Eosin
stain.
For immunohistochemistry, sections will be deparaffinised and by the usage of EDTA
buffer, Heat Induced Epitome Retrieval (HIER) will be done.
At 1:100 dilution incubation of tissues section will be done with ready to use antibody
against IHC markers.
Detection will be done involving 3,3 – diaminobenzene (DAB) detection kit and the
Hydrogen Peroxide Substrate and a DAB chromogen will be used to view markers
antibody staining.
Observations will be made on IHC stained slides and documented.
Immunohistochemical antibodies E cadherin & cyclin D1 of Path n SITU company will be
used.
Prepared slides will be viewed under optical microscope, for positive or negative
immunostaining.
|