Plasma MicroRNA for Prediction of Hepatocellular Carcinoma

• Sponsor: Benha University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05449847
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Actual Duration (Months): 10.2
• Patients Per Site Per Month: 9.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C	Biological: Blood Sampling

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Plasma Expression Levels of MicroRNA-21 Might Help for Detection of HCV Patients Complicated by Hepatocellular Carcinoma
• Actual Study Start Date: May 13, 2021
• Actual Primary Completion Date: Dec 7, 2021
• Actual Study Completion Date: Mar 20, 2022

Arms and Interventions

Arm	Intervention/Treatment
Complicated HCV	Biological: Blood Sampling; Blood sampling under a complete aseptic conditions
Non Complicated HCV	Biological: Blood Sampling; Blood sampling under a complete aseptic conditions

Outcome Measures

Primary Outcome Measures

1. Relation between MicroRNA and HCV [12 months]

   The ability of estimation of plasma microRNA 21 and 126 to differentiate between uncomplicated and complicated HCV patients

Eligibility Criteria

Criteria

• Ages Eligible for Study: 31 Years to 67 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Complicated hepatitis C by HCC

• Complicated hepatitis C by liver cirrhosis

• Complicated hepatitis C by steatohepatitis

• uncomplicated hepatitis C

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Benha university	Banhā	El- Qalyobia	Egypt	13511

Sponsors and Collaborators

• Benha University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Amr M. El Hammady, Assistant professor of Internal Medicine, Benha University
• ClinicalTrials.gov Identifier: NCT05449847
• Other Study ID Numbers: RC 1.7.2021
• First Posted: Jul 8, 2022
• Last Update Posted: Jul 8, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hepatitis C; Carcinoma, Hepatocellular

Study Results

No Results Posted as of Jul 8, 2022