Hepatocellular CarcinomaNCT07404566
Utility of MicroRNAs for Diagnosing Hepatocellular Carcinoma in Hepatitis C Patients
An observational study of Hepatocellular Carcinoma, run by Benha University at 1 site in Egypt.
Trial summary
This study evaluates a target population of patients with Hepatitis C virus (HCV) infection, including those with complications like liver cirrhosis (LC) and hepatocellular carcinoma (HCC), to investigate the diagnostic utility of a specific panel of microRNAs (miRNAs). Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- PCR
- How many people
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2025to 25 Dec 2025
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals attending outpatient clinics for new or chronic HCV follow-up, and healthy volunteers from blood banks, primarily located in Egypt.
Who may be able to join
- Newly diagnosed HCV infection.
- Chronic uncomplicated HCV infection.
- HCV complicated with liver cirrhosis.
- HCV complicated with HCC on top of cirrhosis.
- Willingness to participate and sign written informed consent.
Who cannot join
- Advanced stage of hepatic cirrhosis with portal hypertension or hepatorenal failure.
- Hepatic malignancies other than HCC.
- Bilharzial pre-portal fibrosis.
- Alcoholic fatty liver disease
- hepatosteatosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Merits of Implementing microRNAs for Diagnosing Hepatocellular Carcinoma Among Hepatitis C Patients
This study evaluates a target population of patients with Hepatitis C virus (HCV) infection, including those with complications like liver cirrhosis (LC) and hepatocellular carcinoma (HCC), to investigate the diagnostic utility of a specific panel of microRNAs (miRNAs). The intervention involves quantifying the plasma expression (PE) levels of MiR-21, 1246, 205, 29a-3p, and 497 via PCR and comparing them to healthy controls to determine their efficacy as biomarkers. The primary outcome is to assess the sensitivity, specificity, and overall accuracy of these miRNAs in differentiating HCC from cirrhotic and non-cirrhotic HCV cases, aiming to establish more reliable screening tools than current standard biomarkers like alpha-fetoprotein (AFP).
- Conditions
- Hepatocellular Carcinoma
- Being tested
- PCR
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCRDiagnostic test
PCR quantification of plasma microRNA levels (MiR-21, 1246, 205, 29a-3p, and 497).
| Study group | Role | What they receive |
|---|---|---|
| HCV Group | 21 patients with newly diagnosed or chronic HCV infection, free of findings suggestive of cirrhosis or HCC. Receives: Diagnostic Test: PCR | |
| LC Group | 21 patients with HCV complicated by liver cirrhosis. Receives: Diagnostic Test: PCR | |
| HCC Group | 21 patients with HCV complicated by hepatocellular carcinoma. Receives: Diagnostic Test: PCR | |
| Control Group | 21 healthy volunteers who passed pre-donation investigations at a Blood Bank. Receives: Diagnostic Test: PCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate of Diagnostic Regimens in Identifying Hepatocellular Carcinoma
iagnostic utility (sensitivity, specificity, and accuracy rate) of estimated plasma expression (PE) levels of microRNAs (specifically Mir-1246, Mir-21, and Mir-497) to distinguish HCC from LC and HCV
Measured: Around 3 months
Secondary outcomes (2)
Diagnostic Performance for LC
Differentiating liver cirrhosis using downregulated MiR-205 and overexpressed MiR-29a.
Measured: Around 3 months
Biomarker Correlation
Correlation between miRNA levels and serum Alpha-Fetoprotein (AFP).
Measured: Around 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start15 Aug 2025
- Primary completion25 Nov 2025
- Study completion25 Dec 2025
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 Benha 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raafat R. Mohammed, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07404566
- Sponsor's protocol ID
- E/C.S/N.R15/2025
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Merits of Implementing microRNAs for Diagnosing Hepatocellular Carcinoma Among Hepatitis C Patients
- ClinicalTrials.gov ID
- NCT07404566
- Acronym / sponsor ID
- E/C.S/N.R15/2025
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 25 Nov 2025 (actual)
- Study completion
- 25 Dec 2025 (actual)
- First posted
- 11 Feb 2026 (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 evaluates a target population of patients with Hepatitis C virus (HCV) infection, including those with complications like liver cirrhosis (LC) and hepatocellular carcinoma (HCC), to investigate the diagnostic utility of a specific panel of microRNAs (miRNAs). The intervention involves quantifying the plasma expression (PE) levels of MiR-21, 1246, 205, 29a-3p, and 497 via PCR and comparing them to healthy controls to determine their efficacy as biomarkers. The primary outcome is to assess the sensitivity, specificity, and overall accuracy of these miRNAs in differentiating HCC from cirrhotic and non-cirrhotic HCV cases, aiming to establish more reliable screening tools than current standard biomarkers like alpha-fetoprotein (AFP).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HCV Group | – | Diagnostic Test: PCR21 patients with newly diagnosed or chronic HCV infection, free of findings suggestive of cirrhosis or HCC. |
| LC Group | – | Diagnostic Test: PCR21 patients with HCV complicated by liver cirrhosis. |
| HCC Group | – | Diagnostic Test: PCR21 patients with HCV complicated by hepatocellular carcinoma. |
| Control Group | – | Diagnostic Test: PCR21 healthy volunteers who passed pre-donation investigations at a Blood Bank. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals attending outpatient clinics for new or chronic HCV follow-up, and healthy volunteers from blood banks, primarily located in Egypt.
Key inclusion criteria (5 listed)
- Newly diagnosed HCV infection.
- Chronic uncomplicated HCV infection.
- HCV complicated with liver cirrhosis.
- HCV complicated with HCC on top of cirrhosis.
- Willingness to participate and sign written informed consent.
Key exclusion criteria (5 listed)
- Advanced stage of hepatic cirrhosis with portal hypertension or hepatorenal failure.
- Hepatic malignancies other than HCC.
- Bilharzial pre-portal fibrosis.
- Alcoholic fatty liver disease
- hepatosteatosis.
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 |
|---|---|---|
| PCRPCR quantification of plasma microRNA levels (MiR-21, 1246, 205, 29a-3p, and 497). | Diagnostic test | Control Group, HCC Group, HCV Group, LC Group |
Primary outcome
Success Rate of Diagnostic Regimens in Identifying Hepatocellular Carcinoma
Time frame: Around 3 months
iagnostic utility (sensitivity, specificity, and accuracy rate) of estimated plasma expression (PE) levels of microRNAs (specifically Mir-1246, Mir-21, and Mir-497) to distinguish HCC from LC and HCV
2 secondary outcomes
Diagnostic Performance for LC
Time frame: Around 3 months
Biomarker Correlation
Time frame: Around 3 months
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 12 Feb 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Benha 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 5 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: finished, as of the sponsor's last update on 12 Feb 2026. 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?
Success Rate of Diagnostic Regimens in Identifying Hepatocellular Carcinoma (time frame: Around 3 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 12 Feb 2026.