| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C220||Liver cell carcinoma, |
|
|
Intervention / Comparator Agent
|
|
|
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. |
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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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)?
|
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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. |