| CTRI Number |
CTRI/2023/05/052619 [Registered on: 15/05/2023] Trial Registered Prospectively |
| Last Modified On: |
12/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Determination of cox2 expression in colorectal carcinoma predicts the recurrence rate after surgical resection or adjuvant therapy, the goal of this study is to assess the effectiveness of cox2 as a prognostic marker in colorectal carcinoma by using immunohistochemistry. |
|
Scientific Title of Study
|
To study the utility of COX2 as immunohistochemical prognostic marker in comparison to various histopathological parameters and TNM staging in colorectal carcinoma |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sunita Vagha |
| Designation |
Professor and Head of the Department |
| Affiliation |
JNMC.SWANGI MEGHE.WARDHA |
| Address |
JNMC. Department of Pathology
Histopathology lab
Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9860244638 |
| Fax |
|
| Email |
sunitavagha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunita Vagha |
| Designation |
Professor and Head of the Department |
| Affiliation |
JNMC.SWANGI MEGHE.WARDHA |
| Address |
Datta Meghe Institute of Medical Science
Department of pathology
JNMC. SAWANGI, MEGHE.WARDHA
Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9860244638 |
| Fax |
|
| Email |
sunitavagha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sreetama Mukherjee |
| Designation |
2nd year Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Datta Meghe Institute of Medical Science.
Department of Pathology. Histopathology lab.JNMC
Sawangi,wardha
Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9831554897 |
| Fax |
|
| Email |
sreetama45@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institue of Medical Science.JNMC.Sawangi,Wardha |
|
|
Primary Sponsor
|
| Name |
Datta Meghe institute of Medical Science |
| Address |
Datta Meghe institute of Medical Science.JNMC
Sawangi Meghe.Wardha |
| Type of Sponsor |
Other [DEEMED TO BE UNIVERSITY] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sreetama Mukherjee |
Datta Meghe Institute of Medical Science,JNMC
Sawangi,Wardha |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sreetama Mukherjee |
Acharya Vinoba Bhave Rural Hospital |
Acharya Vinoba Bhave Rural Hospital
Department of pathology.
Histopathology Lab
Wardha
MAHARASHTRA |
9831554897
sreetama45@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| INSTITUTIONALETHICSCOMMITTEE |
Approved |
| INSTITUTIONALETHICSCOMMITTEE |
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: C189||Malignant neoplasm of colon, unspecified, (3) ICD-10 Condition: C189||Malignant neoplasm of colon, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.All cases diagnosed as colorectal carcinoma on histopathology.
2.All colectomy/Hemicolectomy/ Proctocolectomy resection specimens.
3.Primary cases of colorectal carcinoma without any history of previous treatment.
4.All patients presenting with colorectal carcinoma arising Denovo. |
|
| ExclusionCriteria |
| Details |
1.All inflammatory lesions, and other malignancies of the gastrointestinal tract.
2.All biopsy specimens.
3.All treated cases of colorectal carcinoma and cases with recurrence
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Immunohistochemical analysis in determining cox2 expression used as a prognostic marker in colorectal carcinoma in correlation with TNM staging. |
3 YEARS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It can be used to identify patients with poor clinical outcomes and those who will benefit from early diagnosis. |
3 YEARS |
|
|
Target Sample Size
|
Total Sample Size="65"
Sample Size from India="65"
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)
|
15/06/2023 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
ABSTRACT Introduction: The most prevalent neoplasm of the gastrointestinal system is colorectal carcinoma. After lung and breast carcinoma, malignant colorectal cancer appears to be characterized by inflammation. Among the numerous recognized indicators of inflammation, Cyclooxygenase-2 (COX-2) has been identified as playing a key role in the early phases of carcinogenesis. The link between higher expression of COX-2 and the early stages of carcinogenesis and cancer development implies that COX-2 might be a target for precancerous colorectal lesion imaging. Aim: To assess the expression of COX-2 in colorectal carcinoma and the association with histopathological prognostic markers and Tumour Node Metastasis (TNM) staging. Materials and Methods: The current study is an observational, cross-sectional, retrospective, and prospective study that will take place in the Histopathology and Immunohistochemistry unit of the Department of Pathology, Jawaharlal Nehru Medical College, Sawangi (Meghe), Wardha, Maharashtra, India, between the years of 2021 and 2024. The study included approximately 60-65 resected specimens from confirmed and planned Colectomy, Hemicolectomy, and Proctocolectomy specimens received in the Department of General Pathology, JNMC. Observations and results will be collected from the immunohistochemistry study by using COX-2 as a prognostic marker in colorectal carcinoma and correlating it with the TNM staging. Statistical analysis will be made by chi-square test and regression analysis. |