Evaluation of the Role of Aflatoxin as an Environmental Risk Factor Attributable to Liver Cancer in Nile Delta

Study Overview
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Brief Summary
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Hepatocellular carcinoma is multifactorial in etiology and complex in pathogenesis, the blend of risk factors differs in different parts of the world, and this may explain in part the diverse biologic characteristics of HCC in different populations . Exposure to aflatoxin is an additional risk factor for the development of HCC, through damage of DNA in liver cells and mutation in p53 tumor suppressor gene . A previous study showed that aflatoxin B1 has a considerable role in the development of HCC among Egyptians . Clinical studies have shown that AFB1 selectively targets at the third base position of codon 249 of the human p53 gene, a known mutational hotspot in human hepatocellular carcinoma (HCC) . A significant association between aflatoxin exposure and HCC has been reported in hyperendemic areas . A synergistic interaction between AFB1 exposure and viral hepatitis B (HBV) infection on HCC risk has been reported in several epidemiologic studies. Aflatoxin exposure may be associated with advanced liver disease in chronic hepatitis C (HCV) patients. Levels of AFB1-albumin/albumin were significantly related to ultrasono-graphic hepatic parenchyma scores in anti-HCV-positive subjects .

Detailed Description
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Hepatocellular carcinoma (HCC) is the fifth most common malignancy in the world and the third most common cause of cancer-related deaths complicating liver cirrhosis in most cases. In Egypt, there has been a remarkable increase of the proportion of HCC among chronic liver diseases (CLD) patients from 4.0% to 7.2% over a decade. This rising proportion may be explained by the increasing risk factors such as the emergence of hepatitis C virus (HCV) over the same period of time, the contribution of hepatitis B virus (HBV) infection, improvement of the screening programs and diagnostic tools of HCC as well as the increased survival rate among patients with cirrhosis to allow time for some of them to develop HCC . Hepatocellular carcinoma is multifactorial in etiology and complex in pathogenesis, the blend of risk factors differs in different parts of the world, and this may explain in part the diverse biologic characteristics of HCC in different populations . Exposure to aflatoxin is an additional risk factor for the development of HCC, through damage of DNA in liver cells and mutation in p53 tumor suppressor gene . A previous study showed that aflatoxin B1 has a considerable role in the development of HCC among Egyptians . Clinical studies have shown that AFB1 selectively targets at the third base position of codon 249 of the human p53 gene, a known mutational hotspot in human hepatocellular carcinoma (HCC) . A significant association between aflatoxin exposure and HCC has been reported in hyperendemic areas . A synergistic interaction between AFB1 exposure and viral hepatitis B (HBV) infection on HCC risk has been reported in several epidemiologic studies. Aflatoxin exposure may be associated with advanced liver disease in chronic hepatitis C (HCV) patients. Levels of AFB1-albumin/albumin were significantly related to ultrasono-graphic hepatic parenchyma scores in anti-HCV-positive subjects .

Official Title
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Evaluation of the Role of Aflatoxin as an Environmental Risk Factor Attributable to Liver Cancer in Nile Delta

Conditions
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Liver Cancer

Intervention / Treatment
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* Other: Aflatoxin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: cirrhotic patient with and without HCC Exclusion Criteria: Malignancy other than HCC
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Hepatocellular carcinoma (HCC)<br>Estimation of serum aflatoxin level in 40 patients with hepatocellular carcinoma (HCC) | Other: Aflatoxin<br>* Evaluation of Aflatoxin level<br>|
| Other: 20 cirrhotic patients<br>Estimation of serum aflatoxin level in 20 patients with liver cirrhosis | Other: Aflatoxin<br>* Evaluation of Aflatoxin level<br>|
| Other: Control group<br>Estimation of serum aflatoxin level in 15 individuals, as a control group in patient house whom share the same quality of life and whom were neither HCC patients nor cirrhotic patients, were invited to share in the study | Other: Aflatoxin<br>* Evaluation of Aflatoxin level<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Aflatoxin Level in Liver Cancer Patients | Serum aflatoxin level in liver cancer patients in comparison to liver cirrhosis and controls. | 6 months |