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CTRI Number  CTRI/2022/10/046470 [Registered on: 13/10/2022] Trial Registered Prospectively
Last Modified On: 12/09/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Is serum CA 72-4 level better than CEA and CA 19-9 in monitoring gastric cancer treatment 
Scientific Title of Study   Comparing clinical utility of serum CA 72-4 level with CEA and CA 19-9 in monitoring gastric cancer treatment. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shrikant Raut 
Designation  Assistant Professor E 
Affiliation  Tata Memorial Hospital 
Address  Department of Biochemistry, 5th Floor Annexe Building, Tata Memorial Hospital, Parel (E), Mumbai
Dr.E. Borges road, Parel (E), Mumbai 400012
Mumbai
MAHARASHTRA
400012
India 
Phone  7718910464  
Fax    
Email  rautsc@tmc.gov.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Shrikant Raut 
Designation  Assistant Professor E 
Affiliation  Tata Memorial Hospital 
Address  Department of Biochemistry, 5th Floor Annexe Building, Tata Memorial Hospital, Parel (E), Mumbai
Dr.E. Borges road, Parel (E), Mumbai 400012
Mumbai
MAHARASHTRA
400012
India 
Phone  7718910464  
Fax    
Email  rautsc@tmc.gov.in  
 
Details of Contact Person
Public Query  
Name  Dr Shrikant Raut 
Designation  Assistant Professor E 
Affiliation  Tata Memorial Hospital 
Address  Department of Biochemistry, 5th Floor Annexe Building, Tata Memorial Hospital, Parel (E), Mumbai
Dr.E. Borges road, Parel (E), Mumbai 400012
Mumbai
MAHARASHTRA
400012
India 
Phone  7718910464  
Fax    
Email  rautsc@tmc.gov.in  
 
Source of Monetary or Material Support  
Abbott India Ltd 3, Corporate Park, Sion Trombay Road, Mumbai 400071 
Tata Memorial Hospital, Dr.E Borges Road, Parel (E), Mumbai 400012 
 
Primary Sponsor  
Name  Abbott India Ltd 
Address  3, Corporate Park, Sion Trombay Road, Mumbai 400071 
Type of Sponsor  Pharmaceutical industry-Global 
 
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 
Dr Shrikant Raut  Tata Memorial Hospital  Department of Biochemistry, 5th Floor, Annexe Building, Tata Memorial Hospital, Dr.E Borges Road, Parel (E), Mumbai 400012
Mumbai
MAHARASHTRA 		 7718910464

rautsc@tmc.gov.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-1 (Tata Memorial Centre)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C169||Malignant neoplasm of stomach, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Histopathology confirmed, newly diagnosed and previously untreated gastric cancer patients 
 
ExclusionCriteria 
Details  Past or present history of any other cancer, gastric surgery treatment history, severe functional impairment of important organs such as the heart, brain, lung, kidney or liver 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Sensitivity, specificity and positive and negative predictive value of serum CA 72-4, CEA and CA 19-9 will be assessed in the diagnosis of gastric cancer recurrence, at the end of follow-up period of 2 years  All the patients who are newly diagnosed of gastric cancer and planned to receive treatment as per existing disease management protocol will be followed up for 2 year and their serum tumor marker levels will be analyzed at every follow up to monitor the treatment and assess the disease progression. 
 
Secondary Outcome  
Outcome  TimePoints 
Serum CA 72-4, CEA and CA 19-9 levels will be correlated with the imaging performed at baseline and during follow-up as per the existing disease management protocol and routine practice to check for gastric cancer recurrence.  All the patients who are newly diagnosed of gastric cancer and planned to receive treatment as per existing disease management protocol will be followed up for 2 year and their serum tumor marker levels will be analyzed at every follow up and correlated with imaging findings wherever applicable, to monitor the treatment and assess the disease progression. 
 
Target Sample Size   Total Sample Size="246"
Sample Size from India="246" 
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)   01/11/2022 
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   Project yet to be started 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Gastric cancer ranks among the top 5 most common cancers. Notorious for a high postoperative recurrence rate, it is the main reason for death in gastric cancer patients. Serum tumor markers are useful in assessing prognosis and tailoring treatments in various cancers. Among the available tumor markers, carcinoembryonic antigen (CEA) and CA19-9 are both widely used in the follow-up of patients with gastrointestinal malignancies. Various studies which evaluated CA 72-4 as a relatively new tumor marker for gastric cancer and compared its clinical utility with CEA and CA 19-9 observed good specificity. Studies also noted that, it could serve as a prognostic tool, predict recurrent or metastatic disease, and help in post therapeutic follow-up.

The purpose of our study is to monitor treatment of gastric cancer patients with serum CA 72-4 levels in order to assess the response and compare its clinical utility with serum CEA and CA 19-9 levels in monitoring disease progression.

All the patients who are newly diagnosed of gastric cancer and planned to receive treatment as per existing disease management protocol will be followed up for 2 year and their serum tumor marker levels will be analyzed at every follow up to monitor the treatment and assess the disease progression.

We expect serum CA 72-4 to be a better tumor marker as compared to CEA and CA 19-9 in understanding the prognosis and identifying recurrence at an early stage, thereby improving the survival rate in gastric cancer patients.

 
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