Liver CancerNCT02461979
The Role of the Vitamin D Receptor Gene Polymorphisms in Hepatocarcinogenesis
A study testing The VDR genotype in people with Liver Cancer, run by Sherief Abd-Elsalam at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Liver Cancer
- What is being tested?
- The VDR genotype
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2015to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Hcv cirrhotic patient with and without Hcc
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta university - faculty of medicine
Tanta, Elgharbia
Sherief Abdelsalam, lecturer, 00201095159522, Sheriefabdelsalam@yahoo.com
About this study
Official title: The Role of the Vitamin D Receptor Gene Polymorphisms in Hepatocarcinogenesis in Cirrhotic Patients Infected With Chronic Hepatitis C Virus
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.
Read the 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.
- Conditions
- Liver Cancer
- Being tested
- The VDR genotype
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The VDR genotypeOther
The VDR genotype will determined by polymerase chain reaction (PCR) amplication and restriction length fragment polymorphisms.
| Study group | Role | What they receive |
|---|---|---|
| Hepatocellular carcinoma (HCC) | Other | The VDR genotype in 20 HCV cirrhotic patient with HCC Receives: Other: The VDR genotype |
| Liver cirrhosis | Other | The VDR genotype in 20 HCV cirrhotic patient without HCC Receives: Other: The VDR genotype |
| Control group | Other | The The VDR genotype in 10 healthy individuals as control Receives: Other: The VDR genotype |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of HCC patients with abnormal (APAL) VDR polymorphism
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sherief Abd-Elsalam
- Sponsor type
- University, hospital or other
- Collaborators
- Tanta University
- Responsible party
- Sponsor-investigator, Sherief Abd-Elsalam, Tanta University
- Investigators
- Fathia Asal, Prof, Principal investigator, hepatology dept-TantaAmal El Bendary, Professor, Study director, Clinicalpathology dept-TantaWALAA Elkhalawany, lecturer, Study director, hepatology dept-TantaSherief abd-elsalm, lecturer, Study chair, hepatology dept-TantaBasma Shetaa, physician, Study chair, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02461979
- Sponsor's protocol ID
- liver cancer
- Status last verified
- Dec 2017
- First submitted
- 31 May 2015
- Last updated
- 3 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Vitamin D Receptor Gene Polymorphisms in Hepatocarcinogenesis in Cirrhotic Patients Infected With Chronic Hepatitis C Virus
- ClinicalTrials.gov ID
- NCT02461979
- Acronym / sponsor ID
- liver cancer
- Conditions
- Liver Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sherief Abd-ElsalamUniversity, hospital or other
- Collaborators
- Tanta University
- Study start
- Feb 2015
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 3 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hepatocellular carcinoma (HCC) | Other | Other: The VDR genotypeThe VDR genotype in 20 HCV cirrhotic patient with HCC |
| Liver cirrhosis | Other | Other: The VDR genotypeThe VDR genotype in 20 HCV cirrhotic patient without HCC |
| Control group | Other | Other: The VDR genotypeThe The VDR genotype in 10 healthy individuals as control |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Hcv cirrhotic patient with and without Hcc
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The VDR genotypeThe VDR genotype will determined by polymerase chain reaction (PCR) amplication and restriction length fragment polymorphisms. | Other | Control group, Hepatocellular carcinoma (HCC), Liver cirrhosis |
Primary outcome
number of HCC patients with abnormal (APAL) VDR polymorphism
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fathia Asal, Prof principal investigator
hepatology dept-Tanta
Amal El Bendary, Professor study director
Clinicalpathology dept-Tanta
WALAA Elkhalawany, lecturer study director
hepatology dept-Tanta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The VDR genotype in people with Liver Cancer, run by Sherief Abd-Elsalam at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sherief Abd-elsalam, lecturer (00201095159522, Sheriefabdelsalam@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of HCC patients with abnormal (APAL) VDR polymorphism (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2018.