NCT02461966

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 3, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

October 17, 2017

Completed
Last Updated

August 14, 2020

Status Verified

August 1, 2020

Enrollment Period

1.8 years

First QC Date

May 31, 2015

Results QC Date

April 8, 2016

Last Update Submit

August 1, 2020

Conditions

Liver Cancer

Outcome Measures

Primary Outcomes (1)

  • Serum Aflatoxin Level in Liver Cancer Patients

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

    6 months

Study Arms (3)

Hepatocellular carcinoma (HCC)

OTHER

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

Other: Aflatoxin

20 cirrhotic patients

OTHER

Estimation of serum aflatoxin level in 20 patients with liver cirrhosis

Other: Aflatoxin

Control group

OTHER

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

Interventions

AflatoxinOTHER

Evaluation of Aflatoxin level

20 cirrhotic patientsControl groupHepatocellular carcinoma (HCC)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • cirrhotic patient with and without HCC

You may not qualify if:

  • Malignancy other than HCC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta university - faculty of medicine

Cairo, Elgharbia, Egypt

Location

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Aflatoxins

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

BenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingMycotoxinsToxins, BiologicalBiological Factors

Results Point of Contact

Title
Sherief Abd-Elsalam
Organization
Tanta university
sherif_tropical@yahoo.com
00201095159522

Study Officials

  • Mohamed Sharaf-eldin, Prof

    hepatology dept-Tanta

    PRINCIPAL INVESTIGATOR

  • Raafat Salah, Professor

    hepatology dept-Tanta

    STUDY DIRECTOR

  • hanan Soliman, Prof

    hepatology dept-Tanta

    STUDY CHAIR

  • Sherief abd-elsalm, lecturer

    hepatology dept-Tanta

    STUDY CHAIR

  • Walaa Elkhalawany, lecturer

    hepatology dept-Tanta

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
No Masking
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
sponsor investigator

Study Record Dates

First Submitted

May 31, 2015

First Posted

June 3, 2015

Study Start

June 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

August 14, 2020

Results First Posted

October 17, 2017

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)