| 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
|
|
|
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
|
|
|
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. |