Liver Cancer
Conditions
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 .
Interventions
OTHERAflatoxin
Evaluation of Aflatoxin level
Sponsors
Tanta University
Sherief Abd-Elsalam
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
No Masking
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* cirrhotic patient with and without HCC
Exclusion criteria
* Malignancy other than HCC
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Aflatoxin Level in Liver Cancer Patients | 6 months | Serum aflatoxin level in liver cancer patients in comparison to liver cirrhosis and controls. |
Countries
Egypt
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hepatocellular Carcinoma (HCC) Estimation of serum aflatoxin level in 160 patients with hepatocellular carcinoma (HCC)
Aflatoxin: Evaluation of Aflatoxin level | 160 |
| Cirrhotic Patients Estimation of serum aflatoxin level in 80 patients with liver cirrhosis
Aflatoxin: Evaluation of Aflatoxin level | 80 |
| Control Group 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 | 60 |
| Total | 300 |
Baseline characteristics
| Characteristic | Cirrhotic Patients | Control Group | Hepatocellular Carcinoma (HCC) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 17 Participants | 21 Participants | 28 Participants | 66 Participants |
| Age, Categorical Between 18 and 65 years | 63 Participants | 39 Participants | 132 Participants | 234 Participants |
| Age, Continuous Age | 50.00 years STANDARD_DEVIATION 8.72 | 27.80 years STANDARD_DEVIATION 5.06 | 58.58 years STANDARD_DEVIATION 9.58 | 45 years STANDARD_DEVIATION 23.04 |
| Region of Enrollment Egypt | 80 participants | 60 participants | 160 participants | 300 participants |
| Sex: Female, Male Female | 24 Participants | 24 Participants | 28 Participants | 76 Participants |
| Sex: Female, Male Male | 56 Participants | 36 Participants | 132 Participants | 224 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 160 | 0 / 80 | 0 / 60 |
| serious Total, serious adverse events | 0 / 160 | 0 / 80 | 0 / 60 |
Outcome results
Primary
Serum Aflatoxin Level in Liver Cancer Patients
Serum aflatoxin level in liver cancer patients in comparison to liver cirrhosis and controls.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hepatocellular Carcinoma (HCC) | Serum Aflatoxin Level in Liver Cancer Patients | 7.96 ng\ml | Standard Deviation 2.06 |
| 80 Cirrhotic Patients | Serum Aflatoxin Level in Liver Cancer Patients | 6.10 ng\ml | Standard Deviation 1.71 |
| Control Group | Serum Aflatoxin Level in Liver Cancer Patients | 4.13 ng\ml | Standard Deviation 1.67 |