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 .
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- To assess the etiology of HCC in Indian patients.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •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.
排除标准
- •Patients unwilling to give informed consent for data collection.
结局指标
主要结局
To assess the etiology of HCC in Indian patients.
时间窗: 6, 12, 18, 24 months
次要结局
- To record the stage of presentation, mode of presentation and outcomes of standard care of treatment.(6, 12, 18, 24 months)
