Hepatocellular CarcinomaNCT05105828
Predictive Power of Share Wave Fibro Scan in HCC After HCV Infection
An observational study of Hepatocellular Carcinoma, run by Assiut University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Share wave fibro scan
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2020to 30 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Post hepatitis C with HCC above 18 years
Who may be able to join
- Post hepatitis C with HCC
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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 .
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Share wave fibro scan
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| post Hepatitis C patients with hepatocellular carcinoma | post Hepatitis C patients with hepatocellular carcinoma above 18 years Receives: Diagnostic Test: Share wave fibro scan | |
| control group | post Hepatitis C patients without hepatocellular carcinoma above 18 years Receives: Diagnostic Test: Share wave fibro scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start1 Jul 2020
- Primary completion30 Oct 2020
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Roshdy Elkhayat, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105828
- Sponsor's protocol ID
- Share wave fibro scan in HCC
- Status last verified
- Apr 2020
- First submitted
- 23 Oct 2021
- Last updated
- 3 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 24480518Sumida 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 24574716Taylor-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 11358078Ferraioli 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Power of Share Wave Fibro Scan in HCC After HCV Infection
- ClinicalTrials.gov ID
- NCT05105828
- Acronym / sponsor ID
- Share wave fibro scan in HCC
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 3 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 .
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| post Hepatitis C patients with hepatocellular carcinoma | – | Diagnostic Test: Share wave fibro scanpost Hepatitis C patients with hepatocellular carcinoma above 18 years |
| control group | – | Diagnostic Test: Share wave fibro scanpost Hepatitis C patients without hepatocellular carcinoma above 18 years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Post hepatitis C with HCC above 18 years
Key inclusion criteria (1 listed)
- Post hepatitis C with HCC
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Share wave fibro scanShear 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 | Diagnostic test | control group, post Hepatitis C patients with hepatocellular carcinoma |
Primary outcome
Shear wave elastography score
Time frame: through study completion, an average of 1 year
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
- Background: PubMed 24480518Tsochatzis 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.
- Background: PubMed 24574716Sumida 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.
- Background: PubMed 11358078Taylor-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.
- Background: PubMed 22767302Ferraioli 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.
Related trials for Hepatocellular Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shear wave elastography score (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05105828, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2021.