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

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ClinicalTrials.gov Identifier: NCT02461966
Recruitment Status : Completed
First Posted : June 3, 2015
Results First Posted : October 17, 2017
Last Update Posted : October 17, 2017
Sponsor:
Collaborator:
Tanta University
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University

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 .


Condition or disease Intervention/treatment Phase
Liver Cancer Other: Aflatoxin Not Applicable

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 .


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: No Masking
Primary Purpose: Prevention
Official Title: Evaluation of the Role of Aflatoxin as an Environmental Risk Factor Attributable to Liver Cancer in Nile Delta
Study Start Date : June 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Arm Intervention/treatment
Hepatocellular carcinoma (HCC)
Estimation of serum aflatoxin level in 40 patients with hepatocellular carcinoma (HCC)
Other: Aflatoxin
Evaluation of Aflatoxin level

20 cirrhotic patients
Estimation of serum aflatoxin level in 20 patients with liver cirrhosis
Other: Aflatoxin
Evaluation of Aflatoxin level

Control group
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
Evaluation of Aflatoxin level




Primary Outcome Measures :
  1. Serum Aflatoxin Level in Liver Cancer Patients [ Time Frame: 6 months ]
    Serum aflatoxin level in liver cancer patients in comparison to liver cirrhosis and controls.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • cirrhotic patient with and without HCC

Exclusion Criteria:

  • Malignancy other than HCC

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02461966


Locations
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Egypt
Tanta university - faculty of medicine
Cairo, Elgharbia, Egypt
Sponsors and Collaborators
Sherief Abd-Elsalam
Tanta University
Investigators
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Principal Investigator: Mohamed Sharaf-eldin, Prof hepatology dept-Tanta
Study Director: Raafat Salah, Professor hepatology dept-Tanta
Study Chair: hanan Soliman, Prof hepatology dept-Tanta
Study Chair: Sherief abd-elsalm, lecturer hepatology dept-Tanta
Study Chair: Walaa Elkhalawany, lecturer hepatology dept-Tanta

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Responsible Party: Sherief Abd-Elsalam, sponsor investigator, Tanta University
ClinicalTrials.gov Identifier: NCT02461966     History of Changes
Other Study ID Numbers: Aflatoxin
First Posted: June 3, 2015    Key Record Dates
Results First Posted: October 17, 2017
Last Update Posted: October 17, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases