Hepatocellular CarcinomaNCT03722628
The Assesment of MMP-1 Genotypes Polymorphism as a Risk Factor for HCC in Chronic HCV Patients With LC
An observational study of Hepatocellular Carcinoma, run by Assiut University.
Trial summary
Egypt is an endemic area of HCV.Cirrhosis and HCC are the most serious complications of chronic HCV infection.Some studies noted that the risk of HCC increased 17-fold among HCV-infected patients compared with anti-HCV negative controls. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- MMP1 genotypes polymorphism
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2018to 15 Dec 2022
- Phase
- Observational
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Hepatic patients ,males and females
Who may be able to join
- The control popula¬tion comprised 20 healthy individuals with no liver infection. Patients will be subjected to a full history and thorough physical examination.
- The liver will be examined in all patients by local physical examination to detect possible abnormalities.
- The diagnosis of HCC cases include a combination of history, clinical examination ,radiological examination including ultrasound and triphasic computed tomography, Child-Pugh classification, and laboratory investigations including hepatitis C marker.
Who cannot join
- Exclude patients who had chronic hepatitis B virus infection by detecting HBsAg and core total IgG, alcoholism, primary biliary cirrhosis, or autoimmune liver disease, decompensated liver cirrhosis on top of HCV will be excluded.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Assesment of Matrix Metalloproteinase-1 Genotypes Polymorphism as a Risk Factor for Hepatocellular Carcinoma in Chronic Hepatitis C Patients With Liver Cirrhosis
Egypt is an endemic area of HCV.Cirrhosis and HCC are the most serious complications of chronic HCV infection.Some studies noted that the risk of HCC increased 17-fold among HCV-infected patients compared with anti-HCV negative controls.
Many studies demonstrate that direct antiviral therapy seems to accelerate the development of HCC, soon after the end of treatment, in those patients at higher risk of HCC occurrence or recurrence; and preliminary reports seem to indicate that HCC developed after direct antiviral therapy has more aggressive features. These findings clearly indicate the need for aggressive and close monitoring of cirrhotic patients during and after antiviral treatment, to detect and treat HCC at their earliest occurrence.
Read more
Genetic variation plays a key role in HCC susceptibility and development of the disease.Genotype distribution frequency data can be used to map single nucleotide polymorphism (SNP) diversity in a population and to examine the risk and development of specific diseases.Many reports indicate an association between SNPs in certain genes and the susceptibility and clinicopathological status of HCC.
MMP-1 is an endogenous peptide enzyme that is most widely expressed in interstitial collagenase,which can degrade the extracellular matrix surrounding tumor cells. It is involved in many stages of tumorigenesis, in angiogenesis, and in suppression of tumor cell apoptosis .
MMP-1 - 1607 1G/2G (rs1799750) contains a guanine insertion/deletion polymorphism at position - 1607 and is a functional (SNP) that can upregulate MMP expression. The association between the MMP-1 - 1607 1G/2G polymorphism and the emergence of several diseases including the risk for many cancers has been reported.
There are results suggest that MMP-1 is overexpressed in a large proportion of patients with HCC which correlated with the disease progression and poor clinical outcome. Furthermore, MMP-1 high expression proved to be a risk factor for tumor recurrence and independent molecular marker of prognosis in HCC and may become a novel target in the strategies for the prediction of tumor progression and prognosis of this disease.
Aim:
Is to asses:
The contribution of MMP-1-1607 genotype polymorphism to the risk of HCC on top of HCV.
The relationship between MMP-1-1607 gene polymorphism with HCC in patients who received antiviral treatment to HCV.
Read the detailed description
This study is a case-control observational study to be done at Clinical pathology department, Assiut University hospital, Assiut University, Egypt. The control population comprised 20 healthy individuals with no liver infection. Patients will be subjected to a full history and thorough physical examination.The liver will be examined in all patients by local physical examination to detect possible abnormalities.The diagnosis of HCC cases include a combination of history, clinical examination ,radiological examination including ultrasound and triphasic computed tomography, Child-Pugh classification, and laboratory investigations including hepatitis C marker, irrespective of alpha-fetoprotein as it is positive in 30% of cases.
Neither patients nor controls had a history of other malignancy.The diagnosis of liver cirrhosis is based on clinical features, laboratory tests, abdominal ultrasound.
3-Exclusion criteria Exclude patients who had chronic hepatitis B virus infection by detecting HBsAg and core total, alcoholism, primary biliary cirrhosis, or autoimmune liver disease, decompensated liver cirrhosis on top of HCV .
4- Participants All individuals are subjected to the following:-
- Full history taking including the history of taking antiviral drug,clinical examination, abdominal ultrasound.
- Laboratory tests including:
- Routine investigations: CBC,PT \&PC,liver function tests.
- Specific investigations: AFP level, serum level of MMP-1,Determination of MMP-1 gene polymorphism By PCR amplification followed by restriction Fragment length polymorphism (RFLP) and gel electrophoresis.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- MMP1 genotypes polymorphism
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMP1 genotypes polymorphismDiagnostic test
Determination of MMP-1 gene polymorphism By PCR amplification followed by restriction Fragment length polymorphism (RFLP) and gel electrophoresis
| Study group | Role | What they receive |
|---|---|---|
| HCC with TTT | Blood sample from all HCC patients who recieved antiviral treatment for HCV will be taken to detect the MMP1-genotype polymorphism in those patients and the effect of treatment on this polymorphism. Receives: Diagnostic Test: MMP1 genotypes polymorphism | |
| HCC without TTT | Blood sample from all HCC patients who didnot recieve antiviral treatment for HCV will be taken to detect the MMP1-genotype polymorphism in those patients and the effect of treatment on this polymorphism. Receives: Diagnostic Test: MMP1 genotypes polymorphism | |
| LC with TTT | Blood sample from all LC patients who recieved antiviral treatment for HCV will be taken to detect the MMP1-genotype polymorphism in those patients and the effect of treatment on this polymorphism. Receives: Diagnostic Test: MMP1 genotypes polymorphism | |
| LC without TTT | Blood sample from all LC patients who didnot recieve antiviral treatment for HCV will be taken to detect the MMP1-genotype polymorphism in those patients and the effect of treatment on this polymorphism. Receives: Diagnostic Test: MMP1 genotypes polymorphism | |
| Healthy control | MMP1-genotype polymorphism will be applied on those healthy people to detect which type of mutation occur in healthy rather than diseased. Receives: Diagnostic Test: MMP1 genotypes polymorphism |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of Matrix metalloprotinease-1 genotypes polymorphism in the study population
detection by polymerase chain reaction
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start15 Dec 2018 (estimated)
- Primary completion15 Dec 2020 (estimated)
- Study completion15 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HMHassouna, Assiut University
- Investigators
- Zeinab Ahmed Abdelhameed, MD, Study chair, Assiut UniversityMohammed Ismail Sedeek, MD, Study chair, Assiut UniversityNeveen Abdelmonem Kamel, MD, Principal investigator, Assiut UniversityHadier Mostafa Hassouna, M.Sc, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03722628
- Sponsor's protocol ID
- MMP-1 in HCC
- Status last verified
- Oct 2018
- First submitted
- 24 Oct 2018
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Shastry BS. SNP alleles in human disease and evolution. J Hum Genet. 2002;47(11):561-6. doi: 10.1007/s100380200086.
PubMed 12436191Wang B, Hsu CJ, Lee HL, Chou CH, Su CM, Yang SF, Tang CH. Impact of matrix metalloproteinase-11 gene polymorphisms upon the development and progression of hepatocellular carcinoma. Int J Med Sci. 2018 Apr 3;15(6):653-658. doi: 10.7150/ijms.23733. eCollection 2018.
PubMed 29725257
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assesment of Matrix Metalloproteinase-1 Genotypes Polymorphism as a Risk Factor for Hepatocellular Carcinoma in Chronic Hepatitis C Patients With Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT03722628
- Acronym / sponsor ID
- MMP-1 in HCC
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Dec 2018 (estimated)
- Primary completion
- 15 Dec 2020 (estimated)
- Study completion
- 15 Dec 2022 (estimated)
- First posted
- 29 Oct 2018 (actual)
- 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.
Egypt is an endemic area of HCV.Cirrhosis and HCC are the most serious complications of chronic HCV infection.Some studies noted that the risk of HCC increased 17-fold among HCV-infected patients compared with anti-HCV negative controls.
Many studies demonstrate that direct antiviral therapy seems to accelerate the development of HCC, soon after the end of treatment, in those patients at higher risk of HCC occurrence or recurrence; and preliminary reports seem to indicate that HCC developed after direct antiviral therapy has more aggressive features. These findings clearly indicate the need for aggressive and close monitoring of cirrhotic patients during and after antiviral treatment, to detect and treat HCC at their earliest occurrence.
Genetic variation plays a key role in HCC susceptibility and development of the disease.Genotype distribution frequency data can be used to map single nucleotide polymorphism (SNP) diversity in a population and to examine the risk and development of specific diseases.Many reports indicate an association between SNPs in certain genes and the susceptibility and clinicopathological status of HCC.
MMP-1 is an endogenous peptide enzyme that is most widely expressed in interstitial collagenase,which can degrade the extracellular matrix surrounding tumor cells. It is involved in many stages of tumorigenesis, in angiogenesis, and in suppression of tumor cell apoptosis .
MMP-1 - 1607 1G/2G (rs1799750) contains a guanine insertion/deletion polymorphism at position - 1607 and is a functional (SNP) that can upregulate MMP expression. The association between the MMP-1 - 1607 1G/2G polymorphism and the emergence of several diseases including the risk for many cancers has been reported.
There are results suggest that MMP-1 is overexpressed in a large proportion of patients with HCC which correlated with the disease progression and poor clinical outcome. Furthermore, MMP-1 high expression proved to be a risk factor for tumor recurrence and independent molecular marker of prognosis in HCC and may become a novel target in the strategies for the prediction of tumor progression and prognosis of this disease.
Aim:
Is to asses:
The contribution of MMP-1-1607 genotype polymorphism to the risk of HCC on top of HCV.
The relationship between MMP-1-1607 gene polymorphism with HCC in patients who received antiviral treatment to HCV.
Detailed description
This study is a case-control observational study to be done at Clinical pathology department, Assiut University hospital, Assiut University, Egypt. The control population comprised 20 healthy individuals with no liver infection. Patients will be subjected to a full history and thorough physical examination.The liver will be examined in all patients by local physical examination to detect possible abnormalities.The diagnosis of HCC cases include a combination of history, clinical examination ,radiological examination including ultrasound and triphasic computed tomography, Child-Pugh classification, and laboratory investigations including hepatitis C marker, irrespective of alpha-fetoprotein as it is positive in 30% of cases.
Neither patients nor controls had a history of other malignancy.The diagnosis of liver cirrhosis is based on clinical features, laboratory tests, abdominal ultrasound.
3-Exclusion criteria Exclude patients who had chronic hepatitis B virus infection by detecting HBsAg and core total, alcoholism, primary biliary cirrhosis, or autoimmune liver disease, decompensated liver cirrhosis on top of HCV .
4- Participants All individuals are subjected to the following:-
- Full history taking including the history of taking antiviral drug,clinical examination, abdominal ultrasound.
- Laboratory tests including:
- Routine investigations: CBC,PT \&PC,liver function tests.
- Specific investigations: AFP level, serum level of MMP-1,Determination of MMP-1 gene polymorphism By PCR amplification followed by restriction Fragment length polymorphism (RFLP) and gel electrophoresis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| HCC with TTT | – | Diagnostic Test: MMP1 genotypes polymorphismBlood sample from all HCC patients who recieved antiviral treatment for HCV will be taken to detect the MMP1-genotype polymorphism in those patients and the effect of treatment on this polymorphism. |
| HCC without TTT | – | Diagnostic Test: MMP1 genotypes polymorphismBlood sample from all HCC patients who didnot recieve antiviral treatment for HCV will be taken to detect the MMP1-genotype polymorphism in those patients and the effect of treatment on this polymorphism. |
| LC with TTT | – | Diagnostic Test: MMP1 genotypes polymorphismBlood sample from all LC patients who recieved antiviral treatment for HCV will be taken to detect the MMP1-genotype polymorphism in those patients and the effect of treatment on this polymorphism. |
| LC without TTT | – | Diagnostic Test: MMP1 genotypes polymorphismBlood sample from all LC patients who didnot recieve antiviral treatment for HCV will be taken to detect the MMP1-genotype polymorphism in those patients and the effect of treatment on this polymorphism. |
| Healthy control | – | Diagnostic Test: MMP1 genotypes polymorphismMMP1-genotype polymorphism will be applied on those healthy people to detect which type of mutation occur in healthy rather than diseased. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Hepatic patients ,males and females
Key inclusion criteria (3 listed)
- The control popula¬tion comprised 20 healthy individuals with no liver infection. Patients will be subjected to a full history and thorough physical examination.
- The liver will be examined in all patients by local physical examination to detect possible abnormalities.
- The diagnosis of HCC cases include a combination of history, clinical examination ,radiological examination including ultrasound and triphasic computed tomography, Child-Pugh classification, and laboratory investigations including hepatitis C marker.
Key exclusion criteria (1 listed)
- Exclude patients who had chronic hepatitis B virus infection by detecting HBsAg and core total IgG, alcoholism, primary biliary cirrhosis, or autoimmune liver disease, decompensated liver cirrhosis on top of HCV will be excluded.
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 |
|---|---|---|
| MMP1 genotypes polymorphismDetermination of MMP-1 gene polymorphism By PCR amplification followed by restriction Fragment length polymorphism (RFLP) and gel electrophoresis | Diagnostic test | HCC with TTT, HCC without TTT, Healthy control, LC with TTT, LC without TTT |
Primary outcome
The level of Matrix metalloprotinease-1 genotypes polymorphism in the study population
Time frame: 48 hours
detection by polymerase chain reaction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
- Background: PubMed 12436191Shastry BS. SNP alleles in human disease and evolution. J Hum Genet. 2002;47(11):561-6. doi: 10.1007/s100380200086.
- Background: PubMed 29725257Wang B, Hsu CJ, Lee HL, Chou CH, Su CM, Yang SF, Tang CH. Impact of matrix metalloproteinase-11 gene polymorphisms upon the development and progression of hepatocellular carcinoma. Int J Med Sci. 2018 Apr 3;15(6):653-658. doi: 10.7150/ijms.23733. eCollection 2018.
- Individual participant dataSharing planned: Undecided
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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.
Zeinab Ahmed Abdelhameed, MD study chair
Assiut University
Mohammed Ismail Sedeek, MD study chair
Assiut University
Neveen Abdelmonem Kamel, MD principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Assiut University.
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 3 inclusion and 1 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 29 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Hadier Mostafa Hassouna, M.Sc (+201097307417, hadiermostafa2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The level of Matrix metalloprotinease-1 genotypes polymorphism in the study population (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03722628, which also lists 2 linked publications.
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 29 Oct 2018.