Plasma MicroRNA for Prediction of Hepatocellular Carcinoma
Plasma Expression Levels of MicroRNA-21 Might Help for Detection of HCV Patients Complicated by Hepatocellular Carcinoma
1 other identifier
observational
100
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 7, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2022
CompletedFirst Submitted
Initial submission to the registry
July 5, 2022
CompletedFirst Posted
Study publicly available on registry
July 8, 2022
CompletedJuly 8, 2022
July 1, 2022
7 months
July 5, 2022
July 5, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Relation between MicroRNA and HCV
The ability of estimation of plasma microRNA 21 and 126 to differentiate between uncomplicated and complicated HCV patients
12 months
Study Arms (2)
Complicated HCV
Non Complicated HCV
Interventions
Blood sampling under a complete aseptic conditions
Eligibility Criteria
HCV patients
You may qualify if:
- Complicated hepatitis C by HCC
- Complicated hepatitis C by liver cirrhosis
- Complicated hepatitis C by steatohepatitis
- uncomplicated hepatitis C
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Benha Universitylead
Study Sites (1)
Benha university
Banhā, El- Qalyobia, 13511, Egypt
Biospecimen
MicroRNAs (MiR) are naturally occurring short, noncoding RNAs that specifically regulate protein expression and its cumulative effects may lead to broad changes to cell systems and architecture. Deregulated expression levels of MiRs may underlie the development of multiple liver pathologies
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor of Internal Medicine
Study Record Dates
First Submitted
July 5, 2022
First Posted
July 8, 2022
Study Start
May 13, 2021
Primary Completion
December 7, 2021
Study Completion
March 20, 2022
Last Updated
July 8, 2022
Record last verified: 2022-07