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CompletedNCT05105828Updated Nov 3, 2021

Predictive Power of Share Wave Fibro Scan in HCC After HCV Infection

An observational study in Hepatocellular Carcinoma, sponsored by Assiut University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-03.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
110
Ages
18 Years and older
Sex
All
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Study summary

Shear wave electrography score allows stratification of HCC risk in a noninvasive and reliable way and can guide the surveillance strategy for HCC in patients with CLD

Read the detailed description

Liver fibrosis is common to all chronic liver disease (CLD) , With time, this progressive disruption of hepatic architecture can develop into cirrhosis, characterized by "diffuse conversion of normal liver architecture into structurally abnormal nodules", About1% to 4% of patients with HCV-induced liver cirrhosis are diagnosed with HCC each year .

The historical gold standard for quantifying fibrosis is liver biopsy, but its invasive nature and potential for complications make it unpopular among patients and impractical for serial assessments of CLD. Furthermore, since histological lesions are not uniformly distributed across the liver parenchyma, this allows for large sampling error. The need for credible alternatives to biopsy has stimulated research into non-invasive methods of fibrosis assessment, including serum biomarkers , axial imaging and transient elastography.

FibroScan™ (Echosens, Paris, France) allows a non-invasive liver stiffness measurement (LSM), it is a relatively simple, highly reproducible and operator independent technique which examines an area 100 times that of a biopsy, reducing sampling bias , Shear wave elastography (SWE) measures LS by quantifying the velocity of shear waves produced in the liver tissue and uses a normal B-mode ultrasound probe for measuring LS in real time. In addition, SWE imaging using the Aixplorer system provides a high frame-rate and may be able to provide more accurate scoring of fibrosis .

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Conditions studied

  • Hepatocellular Carcinoma
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In context

Hepatitis C

2,321 studies on the registry are indexed under Hepatitis C; 102 are open to participants now.

This study's enrollment of 110 is below the median of 244 across 567 observational studies indexed under Hepatitis C.

Browse Hepatitis C studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Post hepatitis C with HCC above 18 years

Inclusion criteria

  • Post hepatitis C with HCC

Exclusion criteria

Exclusion Criteria:

  • hepatic encephalopathy, ascites or pregnancy, hepatorenal syndrome or hepato-pulmonary syndrome, right side heart failure (liver congestion), extra hepatic tumors, history of liver transplantation, cholestasis, and hepatitis B patient
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
110 participants (actual)
Patient registry
No

Groups and cohorts

  • post Hepatitis C patients with hepatocellular carcinoma

    post Hepatitis C patients with hepatocellular carcinoma above 18 years

    Diagnostic Test: Share wave fibro scan

  • control group

    post Hepatitis C patients without hepatocellular carcinoma above 18 years

    Diagnostic Test: Share wave fibro scan

Interventions

  • Diagnostic testShare wave fibro scan

    Shear wave elastography (SWE) measures LS by quantifying the velocity of shear waves produced in the liver tissue and uses a normal B-mode ultrasound probe for measuring LS in real time. In addition, SWE imaging using the Aixplorer system provides a high frame-rate and may be able to provide more accurate scoring of fibrosis

06

What researchers measure

Primary outcomes

  1. Shear wave elastography score

    it measures liver stiffness as it is a rapid technique taking less than 5 min that can be easily performed at bedside or in outpatient clinic,according to the manufacturer's recommendations and the machine scale result ranges from 2.5 to 75 kPa with normal value around 5.5 kPa

    Time frame: through study completion, an average of 1 year

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Study locations

1 site
  • Assiut University
    Assiut, 71515, Egypt
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References and documents

Publications

  • Tsochatzis EA, Bosch J, Burroughs AK. Liver cirrhosis. Lancet. 2014 May 17;383(9930):1749-61. doi: 10.1016/S0140-6736(14)60121-5. Epub 2014 Jan 28. PubMed 24480518 ↗
  • Sumida Y, Nakajima A, Itoh Y. Limitations of liver biopsy and non-invasive diagnostic tests for the diagnosis of nonalcoholic fatty liver disease/nonalcoholic steatohepatitis. World J Gastroenterol. 2014 Jan 14;20(2):475-85. doi: 10.3748/wjg.v20.i2.475. PubMed 24574716 ↗
  • Taylor-Robinson SD. Applications of magnetic resonance spectroscopy to chronic liver disease. Clin Med (Lond). 2001 Jan-Feb;1(1):54-60. doi: 10.7861/clinmedicine.1-1-54. PubMed 11358078 ↗
  • Ferraioli G, Tinelli C, Dal Bello B, Zicchetti M, Filice G, Filice C; Liver Fibrosis Study Group. Accuracy of real-time shear wave elastography for assessing liver fibrosis in chronic hepatitis C: a pilot study. Hepatology. 2012 Dec;56(6):2125-33. doi: 10.1002/hep.25936. Epub 2012 Aug 31. PubMed 22767302 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05105828
Lead sponsor
Assiut University
Responsible party
Mariam Roshdy Elkhayat (Principle investigator, Assiut University) — Principal investigator
First posted
Nov 3, 2021
Start date
Jul 1, 2020
Primary completion
Oct 30, 2020
Completion
Apr 30, 2021
Last update
Nov 3, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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