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CTRI Number  CTRI/2025/10/095655 [Registered on: 06/10/2025] Trial Registered Prospectively
Last Modified On: 02/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Studying the pattern of androgen receptor and its link to tumor growth and cancer stage in people with colorectal cancer. 
Scientific Title of Study   Assessing the utility of Androgen Receptor (AR) expression as a histopathological marker for tumor behavior in comparison to histopathological parameters and Tumor, Nodes and Metastasis staging in colorectal carcinoma. 
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 Prakritee Sandilya 
Designation  Junior Resident 
Affiliation  Jawaharlal Nehru Medical College, Wardha 
Address  Junior Resident Department of Pathology Datta Meghe Institute of Higher Education & Research Wardha 442005 Maharashtra

Wardha
MAHARASHTRA
442005
India 
Phone  9101294741  
Fax    
Email  prakritee.sandilya96@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Samarth Shukla 
Designation  Professor and Guide 
Affiliation  Jawaharlal Nehru Medical College, Wardha 
Address  Professor and Vice Dean Department of Pathology Datta Meghe Institute of Higher Education & Research Wardha 442005

Wardha
MAHARASHTRA
442005
India 
Phone  8830267710  
Fax    
Email  samarth21174@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Prakritee Sandilya 
Designation  Junior Resident 
Affiliation  Jawaharlal Nehru Medical College, Wardha 
Address  Junior Resident Department of Pathology Datta Meghe Institute of Higher Education & Research Wardha 442005

Wardha
MAHARASHTRA
442005
India 
Phone  9101294741  
Fax    
Email  prakritee.sandilya96@gmail.com  
 
Source of Monetary or Material Support  
Department of Pathology Datta Meghe Institute of Higher Education & Research Wardha 442005 India 
 
Primary Sponsor  
Name  Dr Prakritee Sandilya 
Address  Junior Resident Department of Pathology Datta Meghe Institute of Higher Education & Research Wardha 442005 India 
Type of Sponsor  Other [SELF] 
 
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 Prakritee Sandilya  Acharya Vinoba Bhave Rural Hospital  Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra 442107
Wardha
MAHARASHTRA 		 9101294741

prakritee.sandilya96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C189||Malignant neoplasm of colon, unspecified, (2) ICD-10 Condition: C20||Malignant neoplasm of rectum,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1) Already diagnosed as Colorectal carcinoma on histopathology.
2) All operated cases of colectomy/ hemicolectomy/ abdominoperineal resection with suitable lymph node dissection.
3) Primary cases of Colorectal carcinoma without any history of previous treatment.
4) All patients with Colorectal carcinoma arising de novo. 
 
ExclusionCriteria 
Details  1) All benign lesions of colon and rectum and other malignant carcinomas like neuroendocrine tumors and gastrointestinal stromal tumor.
2) All the already treated cases of Colorectal Carcinoma.
3) All patients with Colorectal carcinoma where the cancer is arising as a result of recurrence.
4) Patients with no histological confirmation of Colorectal Carcinoma.
5) All patients who have defaulted treatment 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The study is expected to determine the significance of androgen receptor expression in colorectal carcinoma by correlating it with tumor behavior, histopathological grade, and TNM staging.  2 years 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
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)   30/10/2025 
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)   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   This prospective and retrospective observational study will be conducted in the Histopathology and Immunohistochemistry sections of the Department of Pathology, Jawaharlal Nehru Medical College, in collaboration with the Department of General Surgery at Acharya Vinoba Bhave Rural Hospital. It will aim to evaluate androgen receptor (AR) expression in colorectal carcinoma using immunohistochemistry and will correlate the findings with histopathological grade and TNM staging. As the incidence of colorectal cancer in India is expected to continue rising, particularly among younger individuals, and with limited research on hormonal influences such as AR, this study will seek to clarify AR’s role in tumor progression and prognosis. The outcomes will help identify high-risk subtypes and may guide the development of hormone-based therapeutic strategies tailored to the Indian population. 
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