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

Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02461966
• Other study ID #: Aflatoxin
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: April 2016

Study information

• Verified date: August 2020
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 .

Description:

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• cirrhotic patient with and without HCC

Exclusion Criteria:

• Malignancy other than HCC

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms

Intervention

Other:
• Aflatoxin
Evaluation of Aflatoxin level

Locations

Country	Name	City	State
Egypt	Tanta university - faculty of medicine	Cairo	Elgharbia

Sponsors (2)

Lead Sponsor	Collaborator
Sherief Abd-Elsalam	Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Aflatoxin Level in Liver Cancer Patients	Serum aflatoxin level in liver cancer patients in comparison to liver cirrhosis and controls.	6 months