NCT03429530

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 12, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

February 15, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

February 12, 2018

Status Verified

February 1, 2018

Enrollment Period

12 months

First QC Date

February 6, 2018

Last Update Submit

February 6, 2018

Conditions

miRna in HCC

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

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

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
DR Hager

Study Record Dates

First Submitted

February 6, 2018

First Posted

February 12, 2018

Study Start

February 15, 2018

Primary Completion

February 1, 2019

Study Completion

March 1, 2019

Last Updated

February 12, 2018

Record last verified: 2018-02