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

• Sponsor: Sherief Abd-Elsalam (Other)
• Overall Status: Completed
• CT.gov ID: NCT02461966
• Collaborator: Tanta University (Other)
• Enrollment: 300
• Location: 1
• Arms: 3
• Duration (Months): 22
• Patients Per Site Per Month: 13.6

Study Details

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 .

Condition or Disease	Intervention/Treatment	Phase
Liver Cancer	Other: Aflatoxin	N/A

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 .

Study Design

• Study Type: Interventional
• 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: Jun 1, 2014
• Actual Primary Completion Date: Apr 1, 2016
• Actual Study Completion Date: Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: Hepatocellular carcinoma (HCC) Estimation of serum aflatoxin level in 40 patients with hepatocellular carcinoma (HCC)	Other: Aflatoxin; Evaluation of Aflatoxin level
Other: 20 cirrhotic patients Estimation of serum aflatoxin level in 20 patients with liver cirrhosis	Other: Aflatoxin; Evaluation of Aflatoxin level
Other: 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

Outcome Measures

Primary Outcome Measures

1. Serum Aflatoxin Level in Liver Cancer Patients [6 months]

   Serum aflatoxin level in liver cancer patients in comparison to liver cirrhosis and controls.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• cirrhotic patient with and without HCC

Exclusion Criteria:

• Malignancy other than HCC

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tanta university - faculty of medicine	Cairo	Elgharbia	Egypt

Sponsors and Collaborators

• Sherief Abd-Elsalam
• Tanta University

Investigators

• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sherief Abd-Elsalam, sponsor investigator, Tanta University
• ClinicalTrials.gov Identifier: NCT02461966
• Other Study ID Numbers: Aflatoxin
• First Posted: Jun 3, 2015
• Last Update Posted: Aug 14, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Liver Neoplasms

Study Results

Participant Flow

Arm/Group Title	Hepatocellular Carcinoma (HCC)	Cirrhotic Patients	Control Group
Arm/Group Description	Estimation of serum aflatoxin level in 160 patients with hepatocellular carcinoma (HCC) Aflatoxin: Evaluation of Aflatoxin level	Estimation of serum aflatoxin level in 80 patients with liver cirrhosis Aflatoxin: Evaluation of Aflatoxin level	Estimation of serum aflatoxin level in 60 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 Aflatoxin: Evaluation of Aflatoxin level
Period Title: Overall Study
STARTED	160	80	60
COMPLETED	160	80	60
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Hepatocellular Carcinoma (HCC)	Cirrhotic Patients	Control Group	Total
Arm/Group Description	Estimation of serum aflatoxin level in 160 patients with hepatocellular carcinoma (HCC) Aflatoxin: Evaluation of Aflatoxin level	Estimation of serum aflatoxin level in 80 patients with liver cirrhosis Aflatoxin: Evaluation of Aflatoxin level	Estimation of serum aflatoxin level in 60 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 Aflatoxin: Evaluation of Aflatoxin level	Total of all reporting groups
Overall Participants	160	80	60	300
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	132 82.5%	63 78.8%	39 65%	234 78%
>=65 years	28 17.5%	17 21.3%	21 35%	66 22%
Age (years) [Mean (Standard Deviation) ]
Age	58.58 (9.58)	50.00 (8.72)	27.80 (5.06)	45 (23.04)
Sex: Female, Male (Count of Participants)
Female	28 17.5%	24 30%	24 40%	76 25.3%
Male	132 82.5%	56 70%	36 60%	224 74.7%
Region of Enrollment (participants) [Number]
Egypt	160 100%	80 100%	60 100%	300 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hepatocellular Carcinoma (HCC)	80 Cirrhotic Patients	Control Group
Arm/Group Description	Estimation of serum aflatoxin level in 160 patients with hepatocellular carcinoma (HCC) Aflatoxin: Evaluation of Aflatoxin level	Estimation of serum aflatoxin level in 80 patients with liver cirrhosis Aflatoxin: Evaluation of Aflatoxin level	Estimation of serum aflatoxin level in 60 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 Aflatoxin: Evaluation of Aflatoxin level
Measure Participants	160	80	60
Mean (Standard Deviation) [ng\ml]	7.96 (2.06)	6.10 (1.71)	4.13 (1.67)

Adverse Events

Time Frame	2 years
Adverse Event Reporting Description	0 means no side effects
Arm/Group Title	Hepatocellular Carcinoma (HCC)		Cirrhotic Patients		Control Group
Arm/Group Description	Estimation of serum aflatoxin level in 160 patients with hepatocellular carcinoma (HCC) Aflatoxin: Evaluation of Aflatoxin level		Estimation of serum aflatoxin level in 80 patients with liver cirrhosis Aflatoxin: Evaluation of Aflatoxin level		Estimation of serum aflatoxin level in 60 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 Aflatoxin: Evaluation of Aflatoxin level
All Cause Mortality
	Hepatocellular Carcinoma (HCC)		Cirrhotic Patients		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Hepatocellular Carcinoma (HCC)		Cirrhotic Patients		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/160 (0%)		0/80 (0%)		0/60 (0%)
Other (Not Including Serious) Adverse Events
	Hepatocellular Carcinoma (HCC)		Cirrhotic Patients		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/160 (0%)		0/80 (0%)		0/60 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.