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CTRI Number  CTRI/2021/05/033905 [Registered on: 31/05/2021] Trial Registered Prospectively
Last Modified On: 18/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Study of tumor markers in terms of their importance in the grade and stage of stomach cancer. 
Scientific Title of Study   Clinicopathological study of gastric carcinoma with special reference to ERK 1/2 and Bcl-2: an observational study in a tertiary care cancer hospital. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Raya Banerjee 
Designation  DNB trainee 
Affiliation  Chittaranjan National Cancer Institute 
Address  Chittaranjan National Cancer Institute, Room Number-110, First Floor, Department Of Pathology, 37-S.P.Mukherjee Road,Kolkata-700026

Kolkata
WEST BENGAL
700026
India 
Phone  7003251081  
Fax    
Email  guria2181994@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Srabanti Hajra 
Designation  Head of the department of Pathology, Chittaranjan national cancer institute 
Affiliation  Chittaranjan National Cancer Institute 
Address  Chittaranjan National Cancer Institute, Room Number-112, First Floor, Department Of Pathology, 37-S.P.Mukherjee Road,Kolkata-700026

Kolkata
WEST BENGAL
700026
India 
Phone  9831425166  
Fax    
Email  drshajra@gmail.com  
 
Details of Contact Person
Public Query  
Name  Raya Banerjee 
Designation  DNB trainee 
Affiliation  Chittaranjan National Cancer Institute 
Address  Chittaranjan National Cancer Institute, Room Number-110, First Floor, Department Of Pathology, 37-S.P.Mukherjee Road,Kolkata-700026

Kolkata
WEST BENGAL
700026
India 
Phone  7003251081  
Fax    
Email  guria2181994@gmail.com  
 
Source of Monetary or Material Support  
Chittaranjan National Cancer Institute 
 
Primary Sponsor  
Name  Chittaranjan National Cancer Institute 
Address  Chittaranjan National Cancer Institute,37-S.P.Mukherjee Road,Kolkata-700026 
Type of Sponsor  Research institution and hospital 
 
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 
Raya Banerjee  Chittaranjan National Cancer Institute  Chittaranjan National Cancer Institute, Room Number-110, First Floor, Department Of Pathology, 37-S.P.Mukherjee Road,Kolkata-700026
Kolkata
WEST BENGAL 		 7003251081

guria2181994@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee, Chittaranjan national cancer institute  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  70.00 Year(s)
Gender  Both 
Details  1. Patients who will be operated for gastric neoplasm and will be diagnosed with malignant
gastric epithelial neoplasms histopathologically.
2. Those who will give informed consent for taking part in the study. 
 
ExclusionCriteria 
Details  1. After histopathological diagnosis all benign gastric neoplasms will be excluded.
2. After histopathological diagnosis gastric neoplasms other than malignant gastric epithelial
neoplasms will be excluded.
3. Cases where Neoadjuvant chemotherapy have been administered.
4. Those who are not willing to take part in the study. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To study the histopathological and clinicopathological parameters of Gastric Carcinoma in Eastern Indian population.
2. To study the expression of biomarkers ERK1/2 and Bcl-2 in gastric carcinoma patients.
3. To study the correlation between histopathological and clinicopathological parameters with ERK1/2 and Bcl-2 expression in gastric carcinoma patients.
 		 2 Years 
 
Secondary Outcome  
Outcome  TimePoints 
To establish a correlation between ERK1/2 and Bcl-2 expression in gastric carcinoma if present.  2 Years 
 
Target Sample Size   Total Sample Size="63"
Sample Size from India="63" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="63" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/06/2021 
Date of Study Completion (India) 30/06/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [guria2181994@gmail.com].

  6. For how long will this data be available start date provided 18-05-2024 and end date provided 18-05-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  		 Gastric adenocarcinoma was the predominant malignant gastric epithelial tumors with Tubular adenocarcinoma being the most frequent. Gastric carcinoma was more prevalent among males with a median age of 54 years and was significantly associated with a mixed diet pattern, smoking and a history of peptic disorder. The common presenting features were abdominal pain, weight loss, vomitting and anorexia. ERK1/2 expression was frequent in gastric carcinoma and showed a statistically significant association with gender, tumor size, Borrmann IV tumors, Diffuse type adenocarcinoma, signet ring and poorly cohesive carcinomas, higher tumor grade, higher T stage, higher N stage, presence of lymphovascular invasion and a higher AJCC prognostic stage. Bcl-2 expression was seen in a large proportion of gastric carcinomas and was significantly associated with gender, tumor size, Borrmann II tumors, Intestinal type adenocarcinomas, tubular and mucinous carcinomas, grade 2 tumors, higher T stage, higher N stage, presence of lymphovascular invasion and a higher AJCC prognostic stage. The association of Bcl-2 with the grade and stage of tumors was mostly seen in the Intestinal type adenocarcinomas. The study hypothesized a statistically significant association between ERK1/2 and Bcl-2 expression in gastric carcinomas, particularly in the Intestinal type, with a higher Bcl-2 expression in tumors having a high ERK1/2 expression. Diffuse type adenocarcinoma failed to show such an association. Higher expression of ERK1/2 and Bcl-2 in tumors having higher grade and higher stage indicated a probable prognostic values of these markers in gastric carcinomas.   
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