The Role of the Vitamin D Receptor Gene Polymorphisms in Hepatocarcinogenesis

Sponsor
Sherief Abd-Elsalam (Other)
Overall Status
Recruiting
CT.gov ID
NCT02461979
Collaborator
Tanta University (Other)
50
1
3
94
0.5

Study Details

Study Description

Brief Summary

Previous data have suggested that vitamin D levels may influence cancer development. In particular, several single nucleotide polymorphisms have been described in the Vitamin D receptor( VDR gene), and some polymorphisms are associated with tumor occurrence. For instance, VDR polymorphisms have been related to cancers of the breast, prostate, skin, colon-rectum, bladder and kidney, although with conflicting observations . VDR polymorphisms have also been investigated in the context of some chronic liver diseases, such as chronic hepatitis B, primary biliary cirrhosis and autoimmune hepatitis . In a recent published study, VDR polymorphism may be used as a molecular marker to predict the risk and to evaluate the disease severity of HCC in patients with chronic hepatitis B.

A significant association of VDR (ApaI) polymorphism with the development of HCC in chronic HCV infection may help to identify those who are at high risk of developing HCC.

Condition or Disease Intervention/Treatment Phase
  • Other: The VDR genotype
N/A

Detailed Description

Hepatitis C virus (HCV) infection is one of the major public health problems worldwide . Chronic HCV infection is characterized by a high rate of progression to fibrosis, chronic hepatitis, leading to cirrhosis and ultimately to hepatocellular carcinoma (HCC). Early detection is critically important because the most effective treatment for HCC is surgical resection or ablation therapy when the tumour is small. On the other hand, genetic factors can also contribute, particularly gene polymorphisms of inflammatory cytokines and growth factor ligands and receptors . Vitamin D is involved in the metabolism of skeleton as a systemic hormone but also has important roles in the regulation of host immune responses, fibrogenesis and development of cancer through vitamin D receptor (VDR). Previous data have suggested that vitamin D levels may influence cancer development. In particular, several single nucleotide polymorphisms have been described in the VDR gene, and some polymorphisms are associated with tumor occurrence. For instance, VDR polymorphisms have been related to cancers of the breast, prostate, skin, colon-rectum, bladder and kidney, although with conflicting observations. VDR polymorphisms have also been investigated in the context of some chronic liver diseases, such as chronic hepatitis B, primary biliary cirrhosis and autoimmune hepatitis . In a recent published study, VDR polymorphism may be used as a molecular marker to predict the risk and to evaluate the disease severity of HCC in patients with chronic hepatitis B.

A significant association of VDR ApaI polymorphism with the development of HCC in chronic HCV infection may help to identify those who are at high risk of developing HCC.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
The Role of the Vitamin D Receptor Gene Polymorphisms in Hepatocarcinogenesis in Cirrhotic Patients Infected With Chronic Hepatitis C Virus
Study Start Date :
Feb 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Hepatocellular carcinoma (HCC)

The VDR genotype in 20 HCV cirrhotic patient with HCC

Other: The VDR genotype
The VDR genotype will determined by polymerase chain reaction (PCR) amplication and restriction length fragment polymorphisms.

Other: Liver cirrhosis

The VDR genotype in 20 HCV cirrhotic patient without HCC

Other: The VDR genotype
The VDR genotype will determined by polymerase chain reaction (PCR) amplication and restriction length fragment polymorphisms.

Other: Control group

The The VDR genotype in 10 healthy individuals as control

Other: The VDR genotype
The VDR genotype will determined by polymerase chain reaction (PCR) amplication and restriction length fragment polymorphisms.

Outcome Measures

Primary Outcome Measures

  1. number of HCC patients with abnormal (APAL) VDR polymorphism [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Hcv cirrhotic patient with and without Hcc
Exclusion Criteria:
  • Malignancy other than HCC

  • Co-infection with Hepatitis B virus (HBV) and Human immunodeficiency virus (HIV)

  • Cirrhosis is due to causes other than chronic hepatitis C

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • Sherief Abd-Elsalam
  • Tanta University

Investigators

  • Principal Investigator: Fathia Asal, Prof, hepatology dept-Tanta
  • Study Director: Amal El Bendary, Professor, Clinicalpathology dept-Tanta
  • Study Director: WALAA Elkhalawany, lecturer, hepatology dept-Tanta
  • Study Chair: Sherief abd-elsalm, lecturer, hepatology dept-Tanta
  • Study Chair: Basma Shetaa, physician, Tanta University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sherief Abd-Elsalam, sponsor investigator, Tanta University
ClinicalTrials.gov Identifier:
NCT02461979
Other Study ID Numbers:
  • liver cancer
First Posted:
Jun 3, 2015
Last Update Posted:
Jan 3, 2018
Last Verified:
Dec 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 3, 2018