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CTRI Number  CTRI/2021/09/036543 [Registered on: 15/09/2021] Trial Registered Prospectively
Last Modified On: 19/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   To find a tumor marker in colorectal cancer where the conventional marker fails and its impact on short term patient survival 
Scientific Title of Study   Study on correlation between CA 19-9 and colorectal carcinoma with normal or near normal CEA and its impact on patient survival 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Avisikta Mallick 
Designation  Junior Resident, Department of General Surgery 
Affiliation  MEDICAL COLLEGE, KOLKATA 
Address  Kalitala para, Memari, East Bardhaman
Kadambini Hostel, 2nd floor, Room no 207, 88, College Street, Kolkata-700073
Kolkata
WEST BENGAL
713146
India 
Phone  08017999074  
Fax    
Email  dravisiktamallick@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Arkaprovo Roy 
Designation  Associate Professor, Department of General Surgery 
Affiliation  MEDICAL COLLEGE, KOLKATA 
Address  8, Nayapatti Road, Plaza Towers, Block B/1, Flat-4
88, College Street, Kolkata-700073
Kolkata
WEST BENGAL
700055
India 
Phone  9830041886  
Fax    
Email  drarkanatmed1997@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Avisikta Mallick 
Designation  Junior Resident, Department of General Surgery 
Affiliation  Kadambini Hostel, 2nd Floor, Room no- 207, MEDICAL COLLEGE, KOLKATA 
Address  Kalitala para, Memari, East Bardhaman
88, College Street, Kolkata-700073
Kolkata
WEST BENGAL
713146
India 
Phone  08017999074  
Fax    
Email  dravisiktamallick@gmail.com  
 
Source of Monetary or Material Support  
Department of General Surgery, Medical College, Kolkata, 88, College Street, Kolkata-700073 
 
Primary Sponsor  
Name  Medical College Kolkata 
Address  88, College street, Kolkata-700073 
Type of Sponsor  Government medical college 
 
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 
Avisikta Mallick  Medical College, Kolkata  Department of General Surgery, Unit III room, David Hare Block, Medical College Kolkata; 88, College Street, Kolkata-700073
Kolkata
WEST BENGAL 
8017999074

dravisiktamallick@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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All newly diagnosed patients with colorectal carcinoma 
 
ExclusionCriteria 
Details  1.Patients with other cancer
2. Patients with pancreatitis, Inflammatory Bowel Disease, Cirrhosis of liver
3.Patients already on systemic chemotherapy or Radiotherapy or concurrent chemoradiation 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
There may be a correlation between serum level of CA 19.9 in colorectal carcinoma with normal or near normal CEA level for early detection and its association with disease prognosis in terms of short term disease free survival and overall survival  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Elevated serum CA 19.9 level is associated with early age at presentation, higher disease staging and poor histologic grading
2. Elevated serum CA 19.9 level at presenation is also associated with poor prognosis 
6 months follow up 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "41"
Final Enrollment numbers achieved (India)="41" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/09/2021 
Date of Study Completion (India) 20/09/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Colorectal carcinoma is the third most common cause of cancer related death worldwide after prostate cancer and lung cancer in males and breast cancer and lung cancer in females. Serum tumor markers including CEA and CA 19-9 are commonly used to predict prognosis in colorectal cancer patients. The American Society of Clinical Oncology (ASCO) guidelines for the use of tumor markers in CRC have recommended CEA measurement for preoperative follow up. However, in routine practice checking the level of CA 19-9 as a marker of colon cancer is not recommended for screening, diagnosis, staging or monitoring colorectal cancer. CA 19-9 was described by Koprowski et al. in 1979 as a monoclonal antibody against a human colorectal cancer cell line. It promotes adhesion of cancer cells to endothelial cells and plays a role in tumor progression in colorectal cancer patients. Several studies have demonstrated the usefulness of CA 19-9 as an indicator of prognosis and recurrence.In view of rising trend of the incidence of colorectal carcinoma in the Indian population this study was taken up to investigate the correlation between CA 19-9 with colorectal carcinoma of Indian origin. Since serum tumor marker assay is an easily applicable and relatively fast and cheap procedure, we investigated the relationship between elevated CA 19-9 level in colorectal carcinoma and evaluated the possible alterations in the level of this biomarker and associated our results with other classical clinicopathologic parameters.

 Therefore, in the present study, we sought to investigate the usefulness of preoperative serum CA 19-9 level as a prognostic factor in a large cohort of colorectal cancer patients at a tertiary hospital.

 

 
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