NCT05105828

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 3, 2021

Completed
Last Updated

November 3, 2021

Status Verified

April 1, 2020

Enrollment Period

4 months

First QC Date

October 23, 2021

Last Update Submit

October 23, 2021

Conditions

Outcome Measures

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

    through study completion, an average of 1 year

Study Arms (2)

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

Share wave fibro scanDIAGNOSTIC_TEST

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

control grouppost Hepatitis C patients with hepatocellular carcinoma

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Post hepatitis C with HCC above 18 years

You may qualify if:

  • Post hepatitis C with HCC

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 71515, Egypt

Location

Related Publications (4)

  • 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.

    PMID: 24480518BACKGROUND
  • 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.

    PMID: 24574716BACKGROUND
  • 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.

    PMID: 11358078BACKGROUND
  • 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.

    PMID: 22767302BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

October 23, 2021

First Posted

November 3, 2021

Study Start

July 1, 2020

Primary Completion

October 30, 2020

Study Completion

April 30, 2021

Last Updated

November 3, 2021

Record last verified: 2020-04

Locations