The Role of the Vitamin D Receptor Gene Polymorphisms in Hepatocarcinogenesis

NCT ID: NCT02461979

Last Updated: 2018-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Liver Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Hepatocellular carcinoma (HCC)

The VDR genotype in 20 HCV cirrhotic patient with HCC

Group Type OTHER

The VDR genotype

Intervention Type OTHER

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

Liver cirrhosis

The VDR genotype in 20 HCV cirrhotic patient without HCC

Group Type OTHER

The VDR genotype

Intervention Type OTHER

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

Control group

The The VDR genotype in 10 healthy individuals as control

Group Type OTHER

The VDR genotype

Intervention Type OTHER

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

Interventions

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The VDR genotype

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

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tanta University

OTHER

Sponsor Role collaborator

Sherief Abd-Elsalam

OTHER

Sponsor Role lead

Responsible Party

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Sherief Abd-Elsalam

sponsor investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Fathia Asal, Prof

Role: PRINCIPAL_INVESTIGATOR

hepatology dept-Tanta

Amal El Bendary, Professor

Role: STUDY_DIRECTOR

Clinicalpathology dept-Tanta

WALAA Elkhalawany, lecturer

Role: STUDY_DIRECTOR

hepatology dept-Tanta

Sherief abd-elsalm, lecturer

Role: STUDY_CHAIR

hepatology dept-Tanta

Basma Shetaa, physician

Role: STUDY_CHAIR

Tanta University

Locations

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Tanta university - faculty of medicine

Tanta, Elgharbia, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Sherief Abd-elsalam, lecturer

Role: CONTACT

00201095159522

Sherief Abd-elsalam, lecturer

Role: CONTACT

00201095159522

Facility Contacts

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Sherief Abdelsalam, lecturer

Role: primary

00201095159522

Other Identifiers

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liver cancer

Identifier Type: -

Identifier Source: org_study_id

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