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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

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Liver Cancer
Intervention Other: Aflatoxin
Enrollment 300
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Hepatocellular Carcinoma (HCC) Cirrhotic Patients Control Group
Hide 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
Arm/Group Title Hepatocellular Carcinoma (HCC) Cirrhotic Patients Control Group Total
Hide 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 Number of Baseline Participants 160 80 60 300
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 160 participants 80 participants 60 participants 300 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
132
  82.5%
63
  78.8%
39
  65.0%
234
  78.0%
>=65 years
28
  17.5%
17
  21.3%
21
  35.0%
66
  22.0%
[1]
Measure Description: Age, categorical numerical
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Age Number Analyzed 160 participants 80 participants 60 participants 300 participants
58.58  (9.58) 50.00  (8.72) 27.80  (5.06) 45  (23.04)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 160 participants 80 participants 60 participants 300 participants
Female
28
  17.5%
24
  30.0%
24
  40.0%
76
  25.3%
Male
132
  82.5%
56
  70.0%
36
  60.0%
224
  74.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Egypt Number Analyzed 160 participants 80 participants 60 participants 300 participants
160 80 60 300
1.Primary Outcome
Title Serum Aflatoxin Level in Liver Cancer Patients
Hide Description Serum aflatoxin level in liver cancer patients in comparison to liver cirrhosis and controls.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hepatocellular Carcinoma (HCC) 80 Cirrhotic Patients Control Group
Hide 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

Overall Number of Participants Analyzed 160 80 60
Mean (Standard Deviation)
Unit of Measure: ng\ml
7.96  (2.06) 6.10  (1.71) 4.13  (1.67)
Time Frame 2 years
Adverse Event Reporting Description 0 means no side effects
 
Arm/Group Title Hepatocellular Carcinoma (HCC) Cirrhotic Patients Control Group
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Hepatocellular Carcinoma (HCC) Cirrhotic Patients Control Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/160 (0.00%)   0/80 (0.00%)   0/60 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Hepatocellular Carcinoma (HCC) Cirrhotic Patients Control Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/160 (0.00%)   0/80 (0.00%)   0/60 (0.00%) 
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.
Results Point of Contact
Name/Title: Sherief Abd-Elsalam
Organization: Tanta university
Phone: 00201095159522
Responsible Party: Sherief Abd-Elsalam, Tanta University
ClinicalTrials.gov Identifier: NCT02461966     History of Changes
Other Study ID Numbers: Aflatoxin
First Submitted: May 31, 2015
First Posted: June 3, 2015
Results First Submitted: April 8, 2016
Results First Posted: October 17, 2017
Last Update Posted: October 17, 2017