Hepatocellular CarcinomaNCT04763707
Serum Visfatin and Serum Vaspin in Patients With Hepatocellular Carcinoma on Top of Liver Cirrhosis
An observational study of Hepatocellular Carcinoma, run by Sohag University at 1 site in Egypt.
Trial summary
Hepatocellular carcinoma (HCC) has a global importance due to its high rate of progression and high mortality rates. Significant risk factors for the development of HCC are metabolic syndrome, obesity and type 2 diabetes mellitus(T2DM). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatocellular Carcinoma
- How many people
- 87 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2021to 1 Nov 2022
- How long will I take part?
- 2 Years
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 70 patients with HCV-related liver cirrhosis attending the outpatient clinic or inpatient section of the department will be included in the study, patients will be categorized into 2 groups: * 40 HCV-related liver cirrhosis patients with HCC on top (Group 1). * 30 HCV-related liver cirrhosis patients(Group 2). * In addition, 20 healthy volunteers will be included as controls(Group 3).
Who may be able to join
- The diagnosis of CHC will be based on positive HCV antibodies by enzyme-linked immunosorbent assay(ELIZA)\& HCV RNA by Polymerase chain reaction ( PCR) for more than 6 months. The diagnosis of liver cirrhosis will be based on clinical data and findings on abdominal ultrasound. The diagnosis of HCC will be based on the typical features of dynamic imaging by triphasic CT with or without elevated serum alpha-fetoprotein (AFP) .
Who cannot join
- - Co-infection with HBV.
- Presence of clinically suspected other causes of hepatocellular injury ( any history of alcoholism, autoimmune hepatitis, primary sclerosing cholangitis (PSC), primary biliary cholangitis (PBC), Wilson's disease, fatty liver disases with metabolic syndrome \&drug induced liver disease.
- Patients diagnosed with other malignancies.
- Patients with history of prior local or systemic HCC-specific treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Accuracy of Serum Visfatin and Serum Vaspin in Patients With Hepatocellular Carcinoma on Top of Liver Cirrhosis
Hepatocellular carcinoma (HCC) has a global importance due to its high rate of progression and high mortality rates. Significant risk factors for the development of HCC are metabolic syndrome, obesity and type 2 diabetes mellitus(T2DM). Dysregulation of adipose tissue derived hormones(adipocytokines/adipokines) might also be involved in obesity-related liver carcinogenesis \& due to the wide spectrum of visfatin and vaspin activities ,we focus in this study on their potential role in patients with HCV-related liver cirrhosis with and without HCC on top.
Read the detailed description
Despite improvements in HCC therapy, the prognosis for HCC patients remains poor due to a high incidence of recurrence. Early diagnosis can significantly improve the overall survival of HCC patients. However, currently available diagnostic markers are still inadequate and limited by their low sensitivity and specificity. For instance, the gold standard marker alpha-fetoprotein (AFP) has a false negative rate up to 40% for early stage of HCC. It is worthy to mention that the level of AFP was reported in a normal range of 25% of patients with advanced HCC.
As such, AFP has been excluded from being a marker for the diagnosis of HCC by Practice Guidelines of the American Association for the study of Liver Diseases (AASLD) and confirmed by other studies.
These discrepancies suggest the need of discovering new reliable diagnostic markers for patients with HCC. An improved understanding of the pathogenesis of HCC development would facilitate the development of more effective outcomes for the diagnosis and treatment of HCC at earlier stages.
- Conditions
- Hepatocellular Carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 : Hepatocellular carcinoma HCC patients with HCV | 40 HCV-related liver cirrhosis patients with HCC on top (Group 1). | |
| Group 2 : Cirrhotic patients with HCV | 30 HCV-related liver cirrhosis patients(Group 2). | |
| Group 3 : Healthy control | 20 healthy volunteers will be included as controls(Group 3). |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum Visfatin & serum Vaspin levels
The 2 markers will be measured in the 3 groups , compared with each one \& asses if they are valuable as diagnostic markers for HCC , staging HCC , chronic liver diseases \& Metabolic disorders.
Measured: they are measured once in all groups then compared after collection of samples, this will be in average 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Apr 2021
- Primary completion1 Oct 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Sohag 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
- 87 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walaa Abdel Hamed Ali, Sohag University
- Investigators
- Khairy Hammam Morsy, Professor, Study director, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04763707
- Sponsor's protocol ID
- Soh-Med-21-02-04
- Status last verified
- Dec 2022
- First submitted
- 16 Feb 2021
- Last updated
- 27 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: we still not decide , due to risk of re-use of data for purposes not approved by participants
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Serum Visfatin and Serum Vaspin in Patients With Hepatocellular Carcinoma on Top of Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT04763707
- Acronym / sponsor ID
- Soh-Med-21-02-04
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 21 Feb 2021 (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.
Hepatocellular carcinoma (HCC) has a global importance due to its high rate of progression and high mortality rates. Significant risk factors for the development of HCC are metabolic syndrome, obesity and type 2 diabetes mellitus(T2DM). Dysregulation of adipose tissue derived hormones(adipocytokines/adipokines) might also be involved in obesity-related liver carcinogenesis \& due to the wide spectrum of visfatin and vaspin activities ,we focus in this study on their potential role in patients with HCV-related liver cirrhosis with and without HCC on top.
Detailed description
Despite improvements in HCC therapy, the prognosis for HCC patients remains poor due to a high incidence of recurrence. Early diagnosis can significantly improve the overall survival of HCC patients. However, currently available diagnostic markers are still inadequate and limited by their low sensitivity and specificity. For instance, the gold standard marker alpha-fetoprotein (AFP) has a false negative rate up to 40% for early stage of HCC. It is worthy to mention that the level of AFP was reported in a normal range of 25% of patients with advanced HCC.
As such, AFP has been excluded from being a marker for the diagnosis of HCC by Practice Guidelines of the American Association for the study of Liver Diseases (AASLD) and confirmed by other studies.
These discrepancies suggest the need of discovering new reliable diagnostic markers for patients with HCC. An improved understanding of the pathogenesis of HCC development would facilitate the development of more effective outcomes for the diagnosis and treatment of HCC at earlier stages.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 : Hepatocellular carcinoma HCC patients with HCV | – | –40 HCV-related liver cirrhosis patients with HCC on top (Group 1). |
| Group 2 : Cirrhotic patients with HCV | – | –30 HCV-related liver cirrhosis patients(Group 2). |
| Group 3 : Healthy control | – | –20 healthy volunteers will be included as controls(Group 3). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 70 patients with HCV-related liver cirrhosis attending the outpatient clinic or inpatient section of the department will be included in the study, patients will be categorized into 2 groups: * 40 HCV-related liver cirrhosis patients with HCC on top (Group 1). * 30 HCV-related liver cirrhosis patients(Group 2). * In addition, 20 healthy volunteers will be included as controls(Group 3).
Key inclusion criteria (1 listed)
- The diagnosis of CHC will be based on positive HCV antibodies by enzyme-linked immunosorbent assay(ELIZA)\& HCV RNA by Polymerase chain reaction ( PCR) for more than 6 months. The diagnosis of liver cirrhosis will be based on clinical data and findings on abdominal ultrasound. The diagnosis of HCC will be based on the typical features of dynamic imaging by triphasic CT with or without elevated serum alpha-fetoprotein (AFP) .
Key exclusion criteria (4 listed)
- - Co-infection with HBV.
- Presence of clinically suspected other causes of hepatocellular injury ( any history of alcoholism, autoimmune hepatitis, primary sclerosing cholangitis (PSC), primary biliary cholangitis (PBC), Wilson's disease, fatty liver disases with metabolic syndrome \&drug induced liver disease.
- Patients diagnosed with other malignancies.
- Patients with history of prior local or systemic HCC-specific treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
serum Visfatin & serum Vaspin levels
Time frame: they are measured once in all groups then compared after collection of samples, this will be in average 1.5 years
The 2 markers will be measured in the 3 groups , compared with each one \& asses if they are valuable as diagnostic markers for HCC , staging HCC , chronic liver diseases \& Metabolic disorders.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2022.
- Individual participant dataSharing planned: Undecided. we still not decide , due to risk of re-use of data for purposes not approved by participants
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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.
Khairy Hammam Morsy, Professor study director
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Sohag University 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 4 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: finished, as of the sponsor's last update on 27 Dec 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum Visfatin & serum Vaspin levels (time frame: they are measured once in all groups then compared after collection of samples, this will be in average 1.5 years). 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 27 Dec 2022.