| CTRI Number |
CTRI/2026/02/102739 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
30/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Studying the role of a blood vessel marker (CD34) in understanding how bowel cancer behaves and spreads. |
|
Scientific Title of Study
|
Assessing the utility of CD34 expression as an immunohistochemical histopathological marker for tumour behavior in comparison to histopathological parameters and tumour,lymph node and metastatic 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 Manya Puri |
| Designation |
Junior resident |
| Affiliation |
JNMC , Wardha |
| Address |
Junior Resident Department of pathology Datta Meghe Institute of Higher Education and Research
Wardha
MAHARASHTRA
442005
India |
| Phone |
9354445180 |
| Fax |
|
| Email |
puri.manya2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Samarth Shukla |
| Designation |
Professor and Guide |
| Affiliation |
JNMC , Wardha |
| Address |
Professor and Vice Dean, Department of pathology Datta Meghe Institute of Higher Education and Research
Wardha
MAHARASHTRA
442005
India |
| Phone |
8830267710 |
| Fax |
|
| Email |
samarth21174@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Samarth Shukla |
| Designation |
Professor and Guide |
| Affiliation |
JNMC , Wardha |
| Address |
Professor and Vice Dean, Department of pathology Datta Meghe Institute of Higher Education and Research
Wardha
MAHARASHTRA
442005
India |
| Phone |
8830267710 |
| Fax |
|
| Email |
samarth21174@gmail.com |
|
|
Source of Monetary or Material Support
|
| Acharya Vinoba Bhave Rural Hospital AVBRH ,Datta Meghe Institute of Higher Education & Research, Wardha, Maharashtra 442107 , India |
|
|
Primary Sponsor
|
| Name |
Manya Puri |
| Address |
Puri Niwas krishna nagar satna MP 485001 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Pathologist |
Department of Pathology jawaharlal nehru medical college Datta Meghe Institute of Higher Education and Research (DMIHER) Meghe Sawangi Wardha Maharashtra 442107 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manya Puri |
Acharya Vinoba Bhave Rural Hospital campus |
Department of Surgery , Acharya Vinoba Bhave Rural Hospital , Datta Meghe Institute of Higher Education and Research(DMIHER), Wardha,Maharashtra
442001
Wardha
Maharashtra
Wardha
MAHARASHTRA |
9354445180
puri.manya2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| EC/NEW/INST/2023/MH/0340 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C18||Malignant neoplasm of colon, (2) ICD-10 Condition: C20||Malignant neoplasm of rectum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Already diagnosed as Colorectal carcinoma on histopathology.
2.All cases with 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.All patients who have defaulted treatment.
5.Patients with no histological confirmation of Colorectal Carcinoma.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study demonstrates that CD34 expression, as a marker of microvessel density (angiogenesis), shows a significant correlation with tumor aggressiveness in colorectal carcinoma. |
24 hours |
|
|
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)
|
16/02/2026 |
| 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
|
Colorectal cancer is one of the common cancers and a major cause of death due to late diagnosis and aggressive tumor behavior One of the important factors responsible for tumor growth and spread is formation of new blood vessels This process is called angiogenesis CD34 is an important marker related to blood vessel formation and tumor progression Increased expression of CD34 is associated with aggressive tumor behavior advanced stage and poor prognosis
This study aims to evaluate CD34 expression in colorectal cancer using immunohistochemistry and correlate it with histopathological grade and TNM staging The study will include confirmed cases of colorectal carcinoma and assess CD34 expression in tumor tissue The results of this study will help in understanding tumor behavior identifying high risk cases and improving prognostic assessment and future treatment planning |