Study of microRNAs as a Diagnostic Tool for HCV-related H... | NCT03429530

Studies
Study of microRNAs as a Diagnostic Tool for HCV-related Hepatocellular Carcinoma

NCT03429530

Sponsor

HMHamed

Status

Unknown status

Last Update Posted

Feb 12, 2018Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

miRna in HCC

Interventions

Not provided

Countries

Not provided

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

Feb 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 15, 2018Estimated

Primary Completion Date

Feb 2019Estimated

Completion Date

Mar 2019Estimated

First Submitted Date

Feb 6, 2018

First Submission Date that Met QC Criteria

Feb 6, 2018

First Posted Date

Feb 12, 2018Actual

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

Feb 6, 2018

Last Update Posted Date

Feb 12, 2018Actual

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

The aim of this work is to study the role of circulating miRNAs in diagnosis of HCV related hepatocellular carcinoma.

Detailed Description

Early diagnosis of hepatocellular carcinoma can significantly improve the overall survival of HCC patients, currently available diagnostic markers are still inadequate and limited by their low sensitivity and specificity. For instance, the gold standard marker, alpha-fetoprotein (AFP), has a false negative rate up to 40% for early stage of HCC. It is worthy to mention that the level of AFP was reported in a normal range of 25% of patients with advanced HCC. These discrepancies suggest the need of discovering new reliable diagnostic markers for patients with HCC. miRNAs are small endogenous, non-coding, ssRNA that are 21-30 nucleotides in length. As for the relationship between miRNA and HCC several studies have demonstrated that the aberrant expression of specific miRNA can be detected in HCC cells and tissues.

miRNAs expression profile analysis has allowed the characterization of 'identity' associated with each type of human cancer and this 'identity' is correlated with carcinogenesis, tumor progression, and response to tumor treatment.

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

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group1		20 patients with chronic HCV
GroupII		20 patient with chronic HCV related liver cirrhosis
GroupIII		40 patients with chronic HCV related liver cirrhosis complicated by hepatocellular cacinoma
group IV		20 healthy blood donors will also be included as a control group

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the role of circulating miRNAs in diagnosis of HCV related hepatocellular carcinoma.	cilculating miRNAs in serum samples of HCV related HCC, HCV related liver cirrhosis , chronic HCV and healthy control group	basline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

RNA extraction and quantitative Real-Time PCR analysis
Diagnosis of HCV will be based on detection of anti-HCV antibodies
Diagnosis of liver cirrhosis will be based on ultrasonography, biochemically and elastography when available
Diagnosis of HCC will be based on ultrasonography, the typical criteria in triphasic multislice CT scan

Exclusion Criteria:

HBV or autoimmune or metabolic liver disease
serological evidence of human immunodeficiency virus (HIV) infection
malignancy in other organs
After intervention in treatment of hepatocellular carcinoma

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

This study will be carried out in Al-Raghy hospital (Assiut university), in collaboration with Medical Microbiology &Immunology Department.

Eighty patients with HCV related chronic liver disease will be included. GroupI; 20 patients with chronic HCV GroupII; 20 patient with chronic HCV related liver cirrhosis GroupIII; 40 patients with chronic HCV related liver cirrhosis complicated by hepatocellular cacinoma Control group: (group IV) Sex and age matched 20 healthy blood donors will also be included as a control group

Sampling Method

Non-Probability Sample