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

Primary Purpose

Liver Cancer

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Aflatoxin
Sponsored by
Sherief Abd-Elsalam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Liver Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • cirrhotic patient with and without HCC

Exclusion Criteria:

  • Malignancy other than HCC

Sites / Locations

  • Tanta university - faculty of medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Hepatocellular carcinoma (HCC)

20 cirrhotic patients

Control group

Arm Description

Estimation of serum aflatoxin level in 40 patients with hepatocellular carcinoma (HCC)

Estimation of serum aflatoxin level in 20 patients with liver cirrhosis

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

Outcomes

Primary Outcome Measures

Serum Aflatoxin Level in Liver Cancer Patients
Serum aflatoxin level in liver cancer patients in comparison to liver cirrhosis and controls.

Secondary Outcome Measures

Full Information

First Posted
May 31, 2015
Last Updated
August 1, 2020
Sponsor
Sherief Abd-Elsalam
Collaborators
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT02461966
Brief Title
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

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sherief Abd-Elsalam
Collaborators
Tanta University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
No Masking
Allocation
Non-Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hepatocellular carcinoma (HCC)
Arm Type
Other
Arm Description
Estimation of serum aflatoxin level in 40 patients with hepatocellular carcinoma (HCC)
Arm Title
20 cirrhotic patients
Arm Type
Other
Arm Description
Estimation of serum aflatoxin level in 20 patients with liver cirrhosis
Arm Title
Control group
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Aflatoxin
Intervention Description
Evaluation of Aflatoxin level
Primary Outcome Measure Information:
Title
Serum Aflatoxin Level in Liver Cancer Patients
Description
Serum aflatoxin level in liver cancer patients in comparison to liver cirrhosis and controls.
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: cirrhotic patient with and without HCC Exclusion Criteria: Malignancy other than HCC
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Sharaf-eldin, Prof
Organizational Affiliation
hepatology dept-Tanta
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Raafat Salah, Professor
Organizational Affiliation
hepatology dept-Tanta
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
hanan Soliman, Prof
Organizational Affiliation
hepatology dept-Tanta
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sherief abd-elsalm, lecturer
Organizational Affiliation
hepatology dept-Tanta
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Walaa Elkhalawany, lecturer
Organizational Affiliation
hepatology dept-Tanta
Official's Role
Study Chair
Facility Information:
Facility Name
Tanta university - faculty of medicine
City
Cairo
State/Province
Elgharbia
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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