SurvivalNCT05568576
Metabolic Syndrome and Long-term Survival Following Liver Resection
An observational study of Survival, run by Assiut University at 1 site in Egypt.
Trial summary
Although hepatitis C virus (HCV) infection remains one of the main causes of hepatocellular carcinoma (HCC) worldwide, metabolic syndrome, with its increase in prevalence, has become an important and significant risk factor for HCC Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Survival
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2015to 30 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with HCC secondary to HCV infection underwent hepatic resection
Who may be able to join
- All patients with HCC secondary to HCV infection underwent hepatic resection
Who cannot join
- HBV patients other modalities of therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metabolic Syndrome and Long-term Survival Following Liver Resection for Hepatocellular Carcinoma Among Patients With Chronic Hepatitis C Virus Infection
Although hepatitis C virus (HCV) infection remains one of the main causes of hepatocellular carcinoma (HCC) worldwide, metabolic syndrome, with its increase in prevalence, has become an important and significant risk factor for HCC
Read the detailed description
Hepatocellular carcinoma (HCC) represents the sixth most common cancer worldwide. In Egypt, it represents the fourth common cancer. Many hospital-based studies reported increasing the incidence of HCC. The reason for increased incidence could be attributed to (1) improvement in screening programs and diagnostic tools, (2) increasing the survival rate of cirrhotic patients that increases the chance of developing HCC, and (3) increasing the incidence and complications of hepatitis C virus (HCV) which is the most important risk factor in developing liver cancer including HCC in Egypt Precise staging of HCC initially is very useful for determination of the therapeutic options and the overall prognosis of the disease. There are certain clinical features upon which most staging systems use for HCC assessment. These clinical features are size and local extent of the tumor, metastasis of the tumor, severity of the liver disease, and the overall patient performance status Several studies in the United States, Europe, Taiwan, Hong Kong , and New Zealand have examined the potential relationships between various metabolic factors and HCC risks, mostly focusing on type 2 DM and obesity. Diabetes , or even prediabetes, has been observed to be a major metabolic factor related to an increased risk of HCC in individuals with HBV infections.
There is paucity in literature about effect of metabolic syndrome on Long-term Survival Following Liver Resection for Hepatocellular Carcinoma Among Patients With Chronic Hepatitis C Virus Infection
- Conditions
- Survival
- Keywords
- Metabolic syndrome, survival, hepatocellular carcinom
- Medical subject headings
- Metabolic Syndrome
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 |
|---|---|---|
| patients with HCC underwent resection | patients with HCC underwent resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
assess frequency long term survival after resection
Measured: between two and five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start1 Jan 2015
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
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 SurvivalStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohammed Abu Elfatth, Assiut University
- Investigators
- Ahmed Shwakt, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05568576
- Sponsor's protocol ID
- ahmedtoH3
- Status last verified
- May 2023
- First submitted
- 2 Oct 2022
- Last updated
- 6 May 2023
- Results posted
- No
- Individual data sharing
- Undecided: with special request
Publications
Tan Y, Zhang X, Zhang W, Tang L, Yang H, Yan K, Jiang L, Yang J, Li C, Yang J, Wen T, Tang H, Yan L. The Influence of Metabolic Syndrome on the Risk of Hepatocellular Carcinoma in Patients with Chronic Hepatitis B Infection in Mainland China. Cancer Epidemiol Biomarkers Prev. 2019 Dec;28(12):2038-2046. doi: 10.1158/1055-9965.EPI-19-0303. Epub 2019 Sep 18.
PubMed 31533942Rashed WM, Kandeil MAM, Mahmoud MO, Ezzat S. Hepatocellular Carcinoma (HCC) in Egypt: A comprehensive overview. J Egypt Natl Canc Inst. 2020 Jan 16;32(1):5. doi: 10.1186/s43046-020-0016-x.
PubMed 32372179
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Syndrome and Long-term Survival Following Liver Resection for Hepatocellular Carcinoma Among Patients With Chronic Hepatitis C Virus Infection
- ClinicalTrials.gov ID
- NCT05568576
- Acronym / sponsor ID
- ahmedtoH3
- Conditions
- Survival
- Keywords
- Metabolic syndrome, survival, hepatocellular carcinom
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 5 Oct 2022 (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.
Although hepatitis C virus (HCV) infection remains one of the main causes of hepatocellular carcinoma (HCC) worldwide, metabolic syndrome, with its increase in prevalence, has become an important and significant risk factor for HCC
Detailed description
Hepatocellular carcinoma (HCC) represents the sixth most common cancer worldwide. In Egypt, it represents the fourth common cancer. Many hospital-based studies reported increasing the incidence of HCC. The reason for increased incidence could be attributed to (1) improvement in screening programs and diagnostic tools, (2) increasing the survival rate of cirrhotic patients that increases the chance of developing HCC, and (3) increasing the incidence and complications of hepatitis C virus (HCV) which is the most important risk factor in developing liver cancer including HCC in Egypt Precise staging of HCC initially is very useful for determination of the therapeutic options and the overall prognosis of the disease. There are certain clinical features upon which most staging systems use for HCC assessment. These clinical features are size and local extent of the tumor, metastasis of the tumor, severity of the liver disease, and the overall patient performance status Several studies in the United States, Europe, Taiwan, Hong Kong , and New Zealand have examined the potential relationships between various metabolic factors and HCC risks, mostly focusing on type 2 DM and obesity. Diabetes , or even prediabetes, has been observed to be a major metabolic factor related to an increased risk of HCC in individuals with HBV infections.
There is paucity in literature about effect of metabolic syndrome on Long-term Survival Following Liver Resection for Hepatocellular Carcinoma Among Patients With Chronic Hepatitis C Virus Infection
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with HCC underwent resection | – | –patients with HCC underwent resection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with HCC secondary to HCV infection underwent hepatic resection
Key inclusion criteria (1 listed)
- All patients with HCC secondary to HCV infection underwent hepatic resection
Key exclusion criteria (1 listed)
- HBV patients other modalities of therapy
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
Survival
Time frame: between two and five years
assess frequency long term survival after resection
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 6 May 2023.
- Results publication: PubMed 31533942Tan Y, Zhang X, Zhang W, Tang L, Yang H, Yan K, Jiang L, Yang J, Li C, Yang J, Wen T, Tang H, Yan L. The Influence of Metabolic Syndrome on the Risk of Hepatocellular Carcinoma in Patients with Chronic Hepatitis B Infection in Mainland China. Cancer Epidemiol Biomarkers Prev. 2019 Dec;28(12):2038-2046. doi: 10.1158/1055-9965.EPI-19-0303. Epub 2019 Sep 18.
- Results publication: PubMed 32372179Rashed WM, Kandeil MAM, Mahmoud MO, Ezzat S. Hepatocellular Carcinoma (HCC) in Egypt: A comprehensive overview. J Egypt Natl Canc Inst. 2020 Jan 16;32(1):5. doi: 10.1186/s43046-020-0016-x.
- Individual participant dataSharing planned: Undecided. with special request
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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.
Ahmed Shwakt study chair
Assiut 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 Survival, run by Assiut 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 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: finished, as of the sponsor's last update on 6 May 2023. 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?
Survival (time frame: between two and five years). 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 NCT05568576, 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 6 May 2023.