| CTRI Number |
CTRI/2026/02/104152 [Registered on: 18/02/2026] Trial Registered Prospectively |
| Last Modified On: |
17/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to See How Certain Proteins Are Linked with the Severity of Urinary Bladder Cancer in Patients. |
|
Scientific Title of Study
|
Expression of EGFR [epidermal growth factor receptor] and her2/neu [human epidermal growth factor receptor] in urinary bladder carcinoma and its Association of clinicopathological parameters |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lalit Kumar Sahare |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no 54 Department of Pathology Pathology block Maulana
Azad Medical College 2 Bahadur Shah Zafar Marg
Central
DELHI
110002
India Old resident doctor hostel maulana azad medical college
Central
DELHI
110002
India Central DELHI 110002 India |
| Phone |
6266755561 |
| Fax |
|
| Email |
lalitsahare9@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Varuna Mallya |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no 54 Department of Pathology Pathology block Maulana
Azad Medical College 2 Bahadur Shah Zafar Marg
Central
DELHI
110002
India Room no 212 Pathology block Maulana
Azad Medical College
Central
DELHI
110002
India Central DELHI 110002 India |
| Phone |
9599966089 |
| Fax |
|
| Email |
varunamallya@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Varuna Mallya |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no 54 Department of Pathology Pathology block Maulana
Azad Medical College 2 Bahadur Shah Zafar Marg
Central
DELHI
110002
India Room No 212 Pathology block Maulana
Azad Medical College 2 Bahadur Shah Zafar Marg
Central
DELHI
110002
India Central DELHI 110002 India |
| Phone |
9599966089 |
| Fax |
|
| Email |
varunamallya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College 2 Bahadur Shah Zafar Marg New Delhi 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
2 Bahadur Shah Zafar Marg New Delhi 110002 |
| 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 Lalit Kumar Sahare |
Maulana Azad Medical College |
Room no. 54 Department of Pathology Pathology block Maulana
Azad Medical College 2 Bahadur Shah Zafar Marg
Central
DELHI
110002
Indi Central DELHI |
6266755561 6266755561 lalitsahare9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College and Assiciated Hospital Lok Nayak GIPMER GuruNanak Eye Center New Delhi 110002 |
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 |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
99.00 Day(s) |
| Gender |
Both |
| Details |
All the newly diagnosed cases of urinary bladder carcinoma whose samples (resected/biopsy)are received in the department of pathology MAMC |
|
| ExclusionCriteria |
| Details |
Patient who have received radiotherapy and chemotherapy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of case of urinary bladder carcinoma showing EGFR and HER2 neu expression |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association between expression of EGFR & HER2 neu with clinicopathological parameter |
1 year |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
04/03/2026 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Bladder cancer, also known as urothelial carcinoma, is the ninth most common malignancy worldwide and a significant cause of cancerrelated morbidity and mortality. The disease shows a marked male predominance and is often associated with risk factors such as cigarette smoking, occupational exposure to carcinogens, chronic cystitis, and certain infections. Despite advances in diagnosis and treatment, recurrence and progression remain major challenges.Epidermal Growth Factor Receptor and Human Epidermal Growth Factor Receptor 2 are members of the ErbB family of tyrosine kinase receptors that regulate cell proliferation, differentiation, and survival. Overexpression or amplification of these receptors has been reported in various malignancies, including urinary bladder carcinoma, and is often correlated with aggressive behavior and poor prognosis.This study aims to evaluate the immunohistochemical expression of EGFR and HER2neu in urinary bladder carcinoma and to analyze their association with clinicopathological parameters such as tumor grade, stage, lymphovascular invasion, and metastasis. A cross-sectional prospective study will be conducted on histologically confirmed cases in the Department of Pathology, Maulana Azad Medical College. Findings from this study may help identify prognostic biomarkers and explore potential targeted therapeutic strategies in urinary bladder carcinoma. |