Plasma MicroRNA for Prediction of Hepatocellular Carcinoma

NCT ID: NCT05449847

Last Updated: 2022-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-13

Study Completion Date

2022-03-20

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatitis C

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Complicated HCV

Blood Sampling

Intervention Type BIOLOGICAL

Blood sampling under a complete aseptic conditions

Non Complicated HCV

Blood Sampling

Intervention Type BIOLOGICAL

Blood sampling under a complete aseptic conditions

Interventions

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Blood Sampling

Blood sampling under a complete aseptic conditions

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

31 Years

Maximum Eligible Age

67 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Benha University

OTHER

Sponsor Role lead

Responsible Party

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Amr M. El Hammady

Assistant professor of Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Benha university

Banhā, El- Qalyobia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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RC 1.7.2021

Identifier Type: -

Identifier Source: org_study_id

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