The Role of the Vitamin D Receptor Gene Polymorphisms in Hepatocarcinogenesis
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 31, 2015
CompletedFirst Posted
Study publicly available on registry
June 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedJanuary 3, 2018
December 1, 2017
7.8 years
May 31, 2015
December 30, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
number of HCC patients with abnormal (APAL) VDR polymorphism
6 months
Study Arms (3)
Hepatocellular carcinoma (HCC)
OTHERThe VDR genotype in 20 HCV cirrhotic patient with HCC
Liver cirrhosis
OTHERThe VDR genotype in 20 HCV cirrhotic patient without HCC
Control group
OTHERThe The VDR genotype in 10 healthy individuals as control
Interventions
The VDR genotype will determined by polymerase chain reaction (PCR) amplication and restriction length fragment polymorphisms.
Eligibility Criteria
You may qualify if:
- Hcv cirrhotic patient with and without Hcc
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sherief Abd-Elsalamlead
- Tanta Universitycollaborator
Study Sites (1)
Tanta university - faculty of medicine
Tanta, Elgharbia, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- 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
February 1, 2015
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
January 3, 2018
Record last verified: 2017-12
Data Sharing
- IPD Sharing
- Will not share