Plasma MicroRNA for Prediction of Hepatocellular Carcinoma | NCT05449847

Studies
Plasma MicroRNA for Prediction of Hepatocellular Carcinoma

NCT05449847

Sponsor

Benha University

Status

Completed

Last Update Posted

Jul 8, 2022Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Hepatitis C

Interventions

Blood Sampling

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 13, 2021Actual

Primary Completion Date

Dec 7, 2021Actual

Completion Date

Mar 20, 2022Actual

First Submitted Date

Jul 5, 2022

First Submission Date that Met QC Criteria

Jul 5, 2022

First Posted Date

Jul 8, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 5, 2022

Last Update Posted Date

Jul 8, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Complicated HCV			Biological: Blood Sampling
Non Complicated HCV			Biological: Blood Sampling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood Sampling	Biological	Blood sampling under a complete aseptic conditions	Complicated HCV Non Complicated HCV

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

31 Years

Maximum Age

67 Years

Standard Ages

AdultOlder Adult

Study Population

HCV patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Benha university		Banhā	El- Qalyobia	13511	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D006526	Hepatitis C

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided

Description

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