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CTRI Number  CTRI/2026/02/103675 [Registered on: 12/02/2026] Trial Registered Prospectively
Last Modified On: 11/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Evaluation of a Stem Cell Marker (CD133) in Colorectal Cancer Patients and Its Role in Predicting Disease Outcome. 
Scientific Title of Study   Immunohistochemical expression of the stem cell marker CD133 in Carcinoma Colorectum 
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 Sanket Pawar 
Designation  Junior Resident 
Affiliation  Datta Meghe Institute of Higher Education and Research (DMIHER) 
Address  Department of Pathology, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research (DMIHER), Sawangi (Meghe), Wardha, Maharashtra, 442107

Wardha
MAHARASHTRA
442107
India 
Phone  9503038188  
Fax    
Email  sanketpawar98@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Arvind Bhake 
Designation  Director Professor 
Affiliation  Datta Meghe Institute of Higher Education and Research (DMIHER) 
Address  Department of Pathology, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research (DMIHER), Sawangi (Meghe), Wardha, Maharashtra, 442107

Wardha
MAHARASHTRA
442107
India 
Phone  9822684255  
Fax    
Email  aravani@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sanket Pawar 
Designation  Junior Resident 
Affiliation  Datta Meghe Institute of Higher Education and Research (DMIHER) 
Address  Department of Pathology, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research (DMIHER), Sawangi (Meghe), Wardha, Maharashtra, 442107

Wardha
MAHARASHTRA
442107
India 
Phone  9503038188  
Fax    
Email  sanketpawar98@yahoo.com  
 
Source of Monetary or Material Support  
Datta Meghe Institute of Higher Education and Research (DMIHER), Sawangi (Meghe), Wardha, Maharashtra - 442107 
 
Primary Sponsor  
Name  Datta Meghe Institute of Higher Education and Research (DMIHER) 
Address  Datta Meghe Institute of Higher Education and Research (DMIHER), Sawangi (Meghe), Wardha, Maharashtra, 442107 
Type of Sponsor  Research institution and hospital 
 
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 Sanket Pawar  Acharya Vinobha Bhave Rural Hospital  Department of Surgery and Department of Pathology, Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute of Higher Education and Research (DMIHER), Wardha, Maharashtra 442107
Wardha
MAHARASHTRA 
9503038188

sanketpawar98@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Datta Meghe Institute of Higher Education and Research  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 
Comparator Agent  NIL  NIL 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Biopsy diagnosed carcinoma colorectum.
The patients diagnosed as carcinoma colorectum on surgically resected specimen.
The patients with the histological diagnosis of adenocarcinoma irrespective of the grade of the tumour.
The patients having adequate clinical details in regards of the adenocarcinoma colorectum. 
 
ExclusionCriteria 
Details  The patients histopathologically diagnosed of cancer of colorectum other than adenocarcinoma.
The patients having inadequate clinical details pertaining to histopathological diagnosis.
The patients having tumour tissue blocks which are inadequate to be processed for CD133 immunostaining. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Demonstration of stem cell marker of CD133 in cancer colorectum is suggested for the purpose of prognostic and predictive value. The results of the present study upon the analysis of IHC of CD133 will enable to segregate the patients of cancer colorectum for the following 3 purposes :
i)By knowing the biological aggressiveness of tumor (prognosis).
ii)The suitability for immunotherapy.
iii)In suggesting the resistance/sensitivity or sensitiveness to radiotherapy. 
2 years 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
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)   10/03/2026 
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="2"
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  

Background

Colorectal carcinoma is a major contributor to cancer-related morbidity and mortality, with rising incidence in the Indian population. Conventional prognostic assessment based on histological grade and TNM staging is increasingly supplemented by molecular markers that may improve prognostication and therapeutic targeting. CD133 (Prominin-1), a cancer stem cell marker, has been reported to correlate with clinicopathological features, prognosis, and resistance to therapy in colorectal carcinoma, although Indian data remain limited. 

 

Research Question

Does immunohistochemical expression of CD133 in colorectal adenocarcinoma demonstrate prognostic value when correlated with established clinicopathological parameters such as tumor grade, lymphovascular invasion, tumor stage, nodal stage, and TNM stage? 

 

Methodology

This study is designed as an observational study with prospective and retrospective recruitment over a two-year period (May 2025–April 2027). Histopathologically confirmed cases of colorectal adenocarcinoma from biopsy or surgical specimens will be included, with an estimated sample size of approximately 40 patients. Clinical, radiological, and pathological data will be collected, followed by routine histopathology and immunohistochemical staining for CD133. Expression will be quantitatively and qualitatively scored and correlated with clinicopathological variables using appropriate statistical tests (Student’s t-test, ANOVA, and Chi-square) through SPSS software. 

 

Conclusion

The study aims to determine whether CD133 expression can serve as a prognostic and predictive biomarker in colorectal carcinoma, potentially aiding in risk stratification, therapeutic decision-making, and assessment of treatment resistance.

 
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