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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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