HCC - Hepatocellular CarcinomaNCT07097870
Predictors of HCC in Post-HCV Cirrhotic Patients After SVR
An observational study of HCC - Hepatocellular Carcinoma, run by Sohag University at 1 site in Egypt.
Trial summary
This study aims to identify clinical and laboratory factors that predict the occurrence of hepatocellular carcinoma (HCC) in Egyptian cirrhotic patients after achieving a sustained virologic response (SVR) to hepatitis C virus (HCV) treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCC - Hepatocellular Carcinoma
- How many people
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2025to Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: post-HCV cirrhotic patient from Egypt, after achieving SVR 12 (between 2016-2019) who did (cases) or did not (controls) develop HCC
Who may be able to join
- for cases:
- age ≥ 18 y;
- HCV related cirrhosis;
- SVR12 after DAA;
- radiologic or histologic HCC diagnosis ≤30 Jun 2025
- for controls: As above plus, ≥36 months post SVR without HCC
Who cannot join
- for cases:
- non HCV cirrhosis or combined HCV-HBV cirrhosis;
- HCC <6 months before SVR;
- concomitant cholangiocarcinoma
- for controls: Same as cases, plus, loss to follow up before 36 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Medicine, Sohag Univesity
Sohag
Zakaria S Gerges, MBBS, +201017718950, zakaria_saeed_post@med.sohag.edu.eg
About this study
Official title: Study of Clinical and Laboratory Predictors of Hepatocellular Carcinoma in Post-HCV Cirrhotic Patients After Sustained Virologic Response.
This study aims to identify clinical and laboratory factors that predict the occurrence of hepatocellular carcinoma (HCC) in Egyptian cirrhotic patients after achieving a sustained virologic response (SVR) to hepatitis C virus (HCV) treatment. This is a retrospective, two-center, case-control study that will include 132 cases and 264 controls. Variables to be analyzed include demographics, liver disease status, metabolic comorbidities, lifestyle factors, medications, as well as laboratory parameters and non-invasive scoring systems.
Read the detailed description
Introduction:
Hepatocellular carcinoma (HCC) is a highly fatal cancer with a global 5-year survival rate of less than 20%. In Egypt, HCC is the most common cancer in men and the leading cause of cancer-related death, primarily due to the historically high prevalence of Hepatitis C Virus (HCV). While sustained virologic response (SVR) after direct-acting antiviral (DAA) therapy significantly reduces the risk of HCC, it can still occur, especially in patients with advanced fibrosis or cirrhosis. This necessitates continued HCC surveillance post-HCV cure.
Aim of Work:
To study various clinical and laboratory predictors of hepatocellular carcinoma in Egyptian cirrhotic patients after achieving sustained virologic response.
Methodology:
Study Design: Retrospective, two-center case-control study.
Setting \& Period: Two tertiary hepatology centers: Sohag University Hospital and Sohag Oncology Center.
SVR was achieved between January 1, 2016 - December 31, 2019
Participants:
Cases: SVR patients who developed HCC
Inclusion Criteria: (1) age ≥ 18 y; (2) HCV related cirrhosis; (3) SVR12 after DAA; (4) radiologic or histologic HCC diagnosis ≤30 Jun 2025
Exclusion Criteria: (1) non HCV cirrhosis or combined HCV-HBV cirrhosis; (2) HCC <6 months before SVR; (3) concomitant cholangiocarcinoma
Controls: SVR patients who did not develop HCC Inclusion Criteria: As above plus,
≥36 months post SVR without HCC
Exclusion Criteria: Same as cases, plus loss to follow-up before 36 months
Sample Size: Using Fleiss' formula yields 120 cases \& 240 controls (360 total). Adding 10 % for incomplete charts ⇒ 132 cases \& 264 controls (≈ 400 subjects).
Variables to Study:
Clinical Predictors: Demographics (Age, Sex, Residence), Liver disease status (History of decompensation, Splenomegaly, Time since SVR), Metabolic comorbidities (Diabetes mellitus, Obesity/BMI, Dyslipidemia, HTN), Lifestyle factors (Smoking, Alcohol use), Medications (Statins, Metformin, Aspirin).
Laboratory Predictors: Platelet count, AST, ALT, AST/ALT ratio, Albumin, Total bilirubin, INR, Alpha-fetoprotein (AFP), HbA1c, Creatinine, Urea, GGT, and ALP.
Non-Invasive Scoring Systems: Child-Pugh Score, MELD Score, FIB-4 Score, ALBI Score, APRI, AAR (AST/ALT ratio).
Ethical Considerations: Approved by IRBs of both centers. Waiver of informed consent granted (retrospective chart review, minimal risk).
Duration: 6 months
- Conditions
- HCC - Hepatocellular Carcinoma
- Keywords
- HCV, Sustained virologic response, HCC, SVR, liver cirrhosis, DAA, Direct acting antivirals
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Cirrhosis
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 |
|---|---|---|
| Cases | SVR patients who developed HCC | |
| Controls | SVR patients who did not develop HCC |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of hepatocellular carcinoma (HCC)
measure occurrence of HCC in post-HCV liver cirrhosis after achieving SVR, by comparing cases to controls
Measured: from SVR12 achievement to 6-9 years later (time of data collection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study startAug 2025 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCC - 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
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zakaria Saeed Gerges Awad, Sohag University
- Investigators
- Usama A Arafa, PhD, Study chair, Faculty of Medicine, Sohag universityAli M Hussein, PhD, Study director, Faculty of Medicine, Sohag university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07097870
- Sponsor's protocol ID
- Soh-Med--25-7-12MS
- Status last verified
- Jul 2025
- First submitted
- 24 Jul 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Clinical and Laboratory Predictors of Hepatocellular Carcinoma in Post-HCV Cirrhotic Patients After Sustained Virologic Response.
- ClinicalTrials.gov ID
- NCT07097870
- Acronym / sponsor ID
- Soh-Med--25-7-12MS
- Conditions
- HCC - Hepatocellular Carcinoma
- Keywords
- HCV, Sustained virologic response, HCC, SVR, liver cirrhosis, DAA, Direct acting antivirals
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 31 Jul 2025 (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.
This study aims to identify clinical and laboratory factors that predict the occurrence of hepatocellular carcinoma (HCC) in Egyptian cirrhotic patients after achieving a sustained virologic response (SVR) to hepatitis C virus (HCV) treatment. This is a retrospective, two-center, case-control study that will include 132 cases and 264 controls. Variables to be analyzed include demographics, liver disease status, metabolic comorbidities, lifestyle factors, medications, as well as laboratory parameters and non-invasive scoring systems.
Detailed description
Introduction:
Hepatocellular carcinoma (HCC) is a highly fatal cancer with a global 5-year survival rate of less than 20%. In Egypt, HCC is the most common cancer in men and the leading cause of cancer-related death, primarily due to the historically high prevalence of Hepatitis C Virus (HCV). While sustained virologic response (SVR) after direct-acting antiviral (DAA) therapy significantly reduces the risk of HCC, it can still occur, especially in patients with advanced fibrosis or cirrhosis. This necessitates continued HCC surveillance post-HCV cure.
Aim of Work:
To study various clinical and laboratory predictors of hepatocellular carcinoma in Egyptian cirrhotic patients after achieving sustained virologic response.
Methodology:
Study Design: Retrospective, two-center case-control study.
Setting \& Period: Two tertiary hepatology centers: Sohag University Hospital and Sohag Oncology Center.
SVR was achieved between January 1, 2016 - December 31, 2019
Participants:
Cases: SVR patients who developed HCC
Inclusion Criteria: (1) age ≥ 18 y; (2) HCV related cirrhosis; (3) SVR12 after DAA; (4) radiologic or histologic HCC diagnosis ≤30 Jun 2025
Exclusion Criteria: (1) non HCV cirrhosis or combined HCV-HBV cirrhosis; (2) HCC <6 months before SVR; (3) concomitant cholangiocarcinoma
Controls: SVR patients who did not develop HCC Inclusion Criteria: As above plus,
≥36 months post SVR without HCC
Exclusion Criteria: Same as cases, plus loss to follow-up before 36 months
Sample Size: Using Fleiss' formula yields 120 cases \& 240 controls (360 total). Adding 10 % for incomplete charts ⇒ 132 cases \& 264 controls (≈ 400 subjects).
Variables to Study:
Clinical Predictors: Demographics (Age, Sex, Residence), Liver disease status (History of decompensation, Splenomegaly, Time since SVR), Metabolic comorbidities (Diabetes mellitus, Obesity/BMI, Dyslipidemia, HTN), Lifestyle factors (Smoking, Alcohol use), Medications (Statins, Metformin, Aspirin).
Laboratory Predictors: Platelet count, AST, ALT, AST/ALT ratio, Albumin, Total bilirubin, INR, Alpha-fetoprotein (AFP), HbA1c, Creatinine, Urea, GGT, and ALP.
Non-Invasive Scoring Systems: Child-Pugh Score, MELD Score, FIB-4 Score, ALBI Score, APRI, AAR (AST/ALT ratio).
Ethical Considerations: Approved by IRBs of both centers. Waiver of informed consent granted (retrospective chart review, minimal risk).
Duration: 6 months
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –SVR patients who developed HCC |
| Controls | – | –SVR patients who did not develop HCC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- post-HCV cirrhotic patient from Egypt, after achieving SVR 12 (between 2016-2019) who did (cases) or did not (controls) develop HCC
Key inclusion criteria (6 listed)
- for cases:
- for controls: As above plus, ≥36 months post SVR without HCC
Key exclusion criteria (5 listed)
- for cases:
- for controls: Same as cases, plus, loss to follow up before 36 months
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
occurrence of hepatocellular carcinoma (HCC)
Time frame: from SVR12 achievement to 6-9 years later (time of data collection)
measure occurrence of HCC in post-HCV liver cirrhosis after achieving SVR, by comparing cases to controls
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
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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.
Usama A Arafa, PhD study chair
Faculty of Medicine, Sohag university
Ali M Hussein, PhD study director
Faculty of Medicine, 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 HCC - 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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 5 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zakaria S Gerges, MBBS (+201017718950, zakaria_saeed_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occurrence of hepatocellular carcinoma (HCC) (time frame: from SVR12 achievement to 6-9 years later (time of data collection)). 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 5 Aug 2025.