Clinical trial NCT02461966: Evaluation of the Role of Aflatoxin as an Environmental Risk Factor Attributable to Liver Cancer in Nile Delta
Official title: Evaluation of the Role of Aflatoxin as an Environmental Risk Factor Attributable to Liver Cancer in Nile Delta
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Cancer
Lead sponsor: Tanta University
Sponsor class: OTHER
Collaborators: name: Tanta University
First posted: 2015-06-03
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 .

Detailed 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 .

Eligibility criteria: Inclusion Criteria:

* cirrhotic patient with and without HCC

Exclusion Criteria:

* Malignancy other than HCC

Primary outcomes:
measure: Serum Aflatoxin Level in Liver Cancer Patients
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Tanta university - faculty of medicine
state: Elgharbia
Study officials:
affiliation: hepatology dept-Tanta
name: Mohamed Sharaf-eldin, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: hepatology dept-Tanta
name: Raafat Salah, Professor
role: STUDY_DIRECTOR
affiliation: hepatology dept-Tanta
name: hanan Soliman, Prof
role: STUDY_CHAIR
affiliation: hepatology dept-Tanta
name: Sherief abd-elsalm, lecturer
role: STUDY_CHAIR
affiliation: hepatology dept-Tanta
name: Walaa Elkhalawany, lecturer
role: STUDY_CHAIR
References: