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CTRI Number  CTRI/2019/12/022387 [Registered on: 16/12/2019] Trial Registered Prospectively
Last Modified On: 13/12/2019
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Liver Cancer data collection in Indian population . 
Scientific Title of Study   An Observational study to see the clinical profile , laboratory abnormalities , imaging findings and outcome with standard medical treatments for Hepatocellular carcinoma: Towards development of a HCC registry . 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mithun Sharma 
Designation  Consultant Hepatologist 
Affiliation  Asian Institute of Gastroenterology 
Address  Cluster M, Department of Hepatology, Room no. 6

Hyderabad
TELANGANA
500032
India 
Phone  08790622655   
Fax  91-40-23324255  
Email  drmithunsharma@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mithun Sharma 
Designation  Consultant Hepatologist 
Affiliation  Asian Institute of Gastroenterology 
Address  Cluster M, Department of Hepatology, Room no. 6

Hyderabad
TELANGANA
500032
India 
Phone  08790622655   
Fax  91-40-23324255  
Email  drmithunsharma@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mithun Sharma 
Designation  Consultant Hepatologist 
Affiliation  Asian Institute of Gastroenterology 
Address  Cluster M, Department of Hepatology, Room no. 6

Hyderabad
TELANGANA
500032
India 
Phone  08790622655   
Fax  91-40-23324255  
Email  drmithunsharma@gmail.com  
 
Source of Monetary or Material Support  
Asian Institute of Gastroenterology. 
 
Primary Sponsor  
Name  Asian Institute of Gastroenterology 
Address  Cluster M, Department of Hepatology, Room no. 6 
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 
Mithun Sharma  Asian Institute of Gastroenterology  Cluster M, Department of Hepatology, Room no. 6
Hyderabad
TELANGANA 
08790622655
91-40-23324255
drmithunsharma@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Asian Institute of Gastroenterology  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C220||Liver cell carcinoma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients with diagnosis of HCC either by imaging or by biopsy as per standard recommendation for diagnosis of HCC will be included in the study. 
 
ExclusionCriteria 
Details  Patients unwilling to give informed consent for data collection. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To assess the etiology of HCC in Indian patients.  6, 12, 18, 24 months 
 
Secondary Outcome  
Outcome  TimePoints 
To record the stage of presentation, mode of presentation and outcomes of standard care of treatment.  6, 12, 18, 24 months 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
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)   16/12/2019 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Guyatt GH, et al. BMJ 2008:336:924–6;EASL CPG HCC. J Hepatol 2018; doi: 10.1016/j.jhep.2018.03.019. Akinyemiju T, et al. JAMA Oncol 2017;3:1683–91 ;EASL CPG HCC. J Hepatol 2018; doi: 10.1016/j.jhep.2018.03.019. Bosman FT, et al. WHO Classification of Tumours of the Digestive System. Fourth Edition. IARC press; 2010. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Hepatocellular carcinoma is one of the leading cause of mortality in patients with liver disease. The most common cause of HCC worldwide is viral ( hepatitis B and C ) followed by alcohol related cirrhosis. The recent increase in the incidence of non-alcoholic fatty liver has made NAFLD as one of the most common emerging cause of liver cancer world wide.  NAFLD along with Hepatitis B can cause HCC even without going through the natural history of cirrhosis followed by HCC . Many of the patients ( around 15%) present with HCC as the first manifestation of liver disease.

Work up of all patients would include routine work up for all patients of cirrhosis and HCC . An effort would be made to identify and find out from history the etiological cause of HCC. No additional tests other than what is required for standard of care would be done . However, with patients consent a 3 ml sample of blood in EDTA vial will be stored and freezed at -80 degree in the research lab for further genetic testing to find out any particular gene. Patient would not be charged for this and they would be told that they are giving the blood sample voluntarily to help research in the field of HCC so that other patients are benefitted by this. The risk factors , biochemical parameters , imaging characteristics , biopsy reports would be captured in Excel sheet . The staging of the liver cancer would be done based on BCLC , Hongkong Liver cancer staging , TNM staging systems . Treatment would be offered as routine as per standard AASLD and EASL guidelines with approved drugs and intervention and would not be influenced based on the data collection.

Since large data from India are few and since at AIG Hospitals , we see a large number of HCC patients being referred from different part of the country , we would like to keep the records of the patients and their progress and observe the clinical and laboratory data for analysis. This will finally lead to the formation of an HCC database which will benefit further research in this field.

 
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