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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HCV Group | 21 patients with newly diagnosed or chronic HCV infection, free of findings suggestive of cirrhosis or HCC. |
| |
| LC Group | 21 patients with HCV complicated by liver cirrhosis. |
| |
| HCC Group | 21 patients with HCV complicated by hepatocellular carcinoma. |
| |
| Control Group | 21 healthy volunteers who passed pre-donation investigations at a Blood Bank. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCR | Diagnostic Test | PCR quantification of plasma microRNA levels (MiR-21, 1246, 205, 29a-3p, and 497). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Around 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Performance for LC | Differentiating liver cirrhosis using downregulated MiR-205 and overexpressed MiR-29a. | Around 3 months |
| Biomarker Correlation | Correlation between miRNA levels and serum Alpha-Fetoprotein (AFP). |
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Inclusion Criteria:
Exclusion Criteria:
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Individuals attending outpatient clinics for new or chronic HCV follow-up, and healthy volunteers from blood banks, primarily located in Egypt.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandria Faculty of medicine | Alexandria | El Alexandria | 21512 | Egypt |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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The study involved the collection of human blood samples, specifically processed into the following formats:
Serum: Obtained by collecting blood in clean tubes, allowing it to clot, and centrifuging at 1000 rpm for 10 minutes.
Plasma/Supernatant: Collected into EDTA-containing tubes and centrifuged to separate the supernatant.
Total RNA: Extracted from the blood samples, specifically including the microRNA fraction for PCR analysis.
Storage and Laboratory Processing
Serum Storage: Serum samples used for alpha-fetoprotein (AFP) ELISA estimation were kept frozen at -20 °C.
RNA Storage: The supernatant for RNA extraction was stored in RNase-free tubes at -80 °C prior to the extraction process.
Molecular Analysis: The retained specimens were used for reverse transcription of cDNA and subsequent Real-time RT-qPCR to determine the relative number of Mir copies using the ΔΔCT method.
| Around 3 months |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |