Hepatitis CNCT05449847
Plasma MicroRNA for Prediction of Hepatocellular Carcinoma
An observational study of Hepatitis C, run by Benha University at 1 site in Egypt.
Trial summary
100 patients with diagnosed HCV were evaluated by clinical and ultrasound examination and were categorized as uncomplicated HCV (n=22) and complicated HCV (n=78). All patients were evaluated for hepatosteatosis and liver fibrosis using the computerized hepatorenal index, the hepatic steatosis index, aspartate… Read more about this study
- Who is it for?
- Ages 31 to 67 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Blood Sampling
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 13 May 2021to 20 Mar 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 31 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HCV patients
Who may be able to join
- Complicated hepatitis C by HCC
- Complicated hepatitis C by liver cirrhosis
- Complicated hepatitis C by steatohepatitis
- uncomplicated hepatitis C
Who cannot join
- pre-portal fibrosis secondary to previous bilharzial disease
- pre-portal fibrosis secondary to alcoholic fatty liver
- The presence of hepatic malignancy other than HCC
- decompensated cirrhosis
- hepatorenal failure
- hepatic manifestations of congestive heart failure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Plasma Expression Levels of MicroRNA-21 Might Help for Detection of HCV Patients Complicated by Hepatocellular Carcinoma
100 patients with diagnosed HCV were evaluated by clinical and ultrasound examination and were categorized as uncomplicated HCV (n=22) and complicated HCV (n=78). All patients were evaluated for hepatosteatosis and liver fibrosis using the computerized hepatorenal index, the hepatic steatosis index, aspartate aminotransferase (AST)/platelet count index (APRI) and the Fibrosis-4 (FIB-4) scores. Blood samples were obtained for estimation of serum levels of liver function tests and plasma levels of microRNA 21 and 126.
- Conditions
- Hepatitis C
- Being tested
- Blood Sampling
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood SamplingBiological
Blood sampling under a complete aseptic conditions
| Study group | Role | What they receive |
|---|---|---|
| Complicated HCV | Not described Receives: Biological: Blood Sampling | |
| Non Complicated HCV | Not described Receives: Biological: Blood Sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relation between MicroRNA and HCV
The ability of estimation of plasma microRNA 21 and 126 to differentiate between uncomplicated and complicated HCV patients
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start13 May 2021
- Primary completion7 Dec 2021
- Study completion20 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr M. El Hammady, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05449847
- Sponsor's protocol ID
- RC 1.7.2021
- Status last verified
- Jul 2022
- First submitted
- 5 Jul 2022
- Last updated
- 8 Jul 2022
- 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 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Expression Levels of MicroRNA-21 Might Help for Detection of HCV Patients Complicated by Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05449847
- Acronym / sponsor ID
- RC 1.7.2021
- Conditions
- Hepatitis C
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 13 May 2021 (actual)
- Primary completion
- 7 Dec 2021 (actual)
- Study completion
- 20 Mar 2022 (actual)
- First posted
- 8 Jul 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.
100 patients with diagnosed HCV were evaluated by clinical and ultrasound examination and were categorized as uncomplicated HCV (n=22) and complicated HCV (n=78). All patients were evaluated for hepatosteatosis and liver fibrosis using the computerized hepatorenal index, the hepatic steatosis index, aspartate aminotransferase (AST)/platelet count index (APRI) and the Fibrosis-4 (FIB-4) scores. Blood samples were obtained for estimation of serum levels of liver function tests and plasma levels of microRNA 21 and 126.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Complicated HCV | – | Biological: Blood Sampling |
| Non Complicated HCV | – | Biological: Blood Sampling |
Who may qualify
- Ages
- 31 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HCV patients
Key inclusion criteria (4 listed)
- Complicated hepatitis C by HCC
- Complicated hepatitis C by liver cirrhosis
- Complicated hepatitis C by steatohepatitis
- uncomplicated hepatitis C
Key exclusion criteria (6 listed)
- pre-portal fibrosis secondary to previous bilharzial disease
- pre-portal fibrosis secondary to alcoholic fatty liver
- The presence of hepatic malignancy other than HCC
- decompensated cirrhosis
- hepatorenal failure
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 |
|---|---|---|
| Blood SamplingBlood sampling under a complete aseptic conditions | Biological | Complicated HCV, Non Complicated HCV |
Primary outcome
Relation between MicroRNA and HCV
Time frame: 12 months
The ability of estimation of plasma microRNA 21 and 126 to differentiate between uncomplicated and complicated HCV patients
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 8 Jul 2022.
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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 Hepatitis C, 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 4 inclusion and 6 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 8 Jul 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?
Relation between MicroRNA and HCV (time frame: 12 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 8 Jul 2022.