Trial Outcomes & Findings for Evaluation of the Role of Aflatoxin as an Environmental Risk Factor Attributable to Liver Cancer in Nile Delta (NCT NCT02461966)

NCT ID: NCT02461966

Last Updated: 2020-08-14

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 300 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2020-08-14

Participant Flow

Participant milestones

Measure	Hepatocellular Carcinoma (HCC) Estimation of serum aflatoxin level in 160 patients with hepatocellular carcinoma (HCC) Aflatoxin: Evaluation of Aflatoxin level	Cirrhotic Patients Estimation of serum aflatoxin level in 80 patients with liver cirrhosis Aflatoxin: Evaluation of Aflatoxin level	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
Overall Study STARTED	160	80	60
Overall Study COMPLETED	160	80	60
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Hepatocellular Carcinoma (HCC) n=160 Participants Estimation of serum aflatoxin level in 160 patients with hepatocellular carcinoma (HCC) Aflatoxin: Evaluation of Aflatoxin level	Cirrhotic Patients n=80 Participants Estimation of serum aflatoxin level in 80 patients with liver cirrhosis Aflatoxin: Evaluation of Aflatoxin level	Control Group n=60 Participants 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 n=300 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	132 Participants n=5 Participants	63 Participants n=7 Participants	39 Participants n=5 Participants	234 Participants n=4 Participants
Age, Categorical >=65 years	28 Participants n=5 Participants	17 Participants n=7 Participants	21 Participants n=5 Participants	66 Participants n=4 Participants
Age, Continuous Age	58.58 years STANDARD_DEVIATION 9.58 • n=5 Participants	50.00 years STANDARD_DEVIATION 8.72 • n=7 Participants	27.80 years STANDARD_DEVIATION 5.06 • n=5 Participants	45 years STANDARD_DEVIATION 23.04 • n=4 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	24 Participants n=7 Participants	24 Participants n=5 Participants	76 Participants n=4 Participants
Sex: Female, Male Male	132 Participants n=5 Participants	56 Participants n=7 Participants	36 Participants n=5 Participants	224 Participants n=4 Participants
Region of Enrollment Egypt	160 participants n=5 Participants	80 participants n=7 Participants	60 participants n=5 Participants	300 participants n=4 Participants

PRIMARY outcome

Timeframe: 6 months

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

Outcome measures

Measure	Hepatocellular Carcinoma (HCC) n=160 Participants Estimation of serum aflatoxin level in 160 patients with hepatocellular carcinoma (HCC) Aflatoxin: Evaluation of Aflatoxin level	80 Cirrhotic Patients n=80 Participants Estimation of serum aflatoxin level in 80 patients with liver cirrhosis Aflatoxin: Evaluation of Aflatoxin level	Control Group n=60 Participants 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
Serum Aflatoxin Level in Liver Cancer Patients	7.96 ng\ml Standard Deviation 2.06	6.10 ng\ml Standard Deviation 1.71	4.13 ng\ml Standard Deviation 1.67

Adverse Events

Hepatocellular Carcinoma (HCC)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cirrhotic Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sherief Abd-Elsalam

Tanta university

Phone: 00201095159522

Email: sherif_tropical@yahoo.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place