| 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 |
|
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Details of Secondary Sponsor
|
|
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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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C189||Malignant neoplasm of colon, unspecified, |
|
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Intervention / Comparator Agent
|
|
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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 |
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
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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. |