Hepatocellular CarcinomaYliverDIAGNCT03767764
Yliver as a Test to Early Diagnose HCC
An observational study of Hepatocellular Carcinoma, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
Liver cancer (HCC) is the second cause of death related to cancer worldwide, with about 750,000 deaths from this cause in 2012. Although the early diagnosis of liver cancer increases the available treatment options, the methods currently used for screening are not sufficiently sensitive for this purpose. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Test Yliver
- How many people
- 190 participants
- Where
- 1 siteSpain
- Study dates
- 27 Dec 2018to 1 Sep 2020
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: HCC: patients with HCC diagnosis Cirrhosis: patients with liver cirrhosis diagnosis Chronic liver disease: patients with chronic liver diasease without cirrhosis Control: normal human serum from donors without liver disease
Who may be able to join
- EASL Clinical Practice Guidelines \& Practice Guidance by the American Association for the Study of Liver Diseases for diagnosis of HCC, liver cirrhosis, chronic hepatitis without cirrhosis
Who cannot join
- Age under 18 years
- Very advanced disease (patient in a terminal state that is not indicated analytical determinations).
- Hepatic encephalopathy that prevents the correct understanding of informed consent.
- Refusal to carry out the determination or to sign the informed consent.
- Patients affected by another neoplastic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Yliver as a Test to Early Diagnose Hepatocellular Carcinoma
Liver cancer (HCC) is the second cause of death related to cancer worldwide, with about 750,000 deaths from this cause in 2012. Although the early diagnosis of liver cancer increases the available treatment options, the methods currently used for screening are not sufficiently sensitive for this purpose.
The investigators provide a high-performance and highly reliable in vitro platform that allows the identification and quantification of autoantibodies in serum for use as biomarkers of liver cancer, using an ELISA test (Yliver).
The aim of the study is to demonstrate whether the Yliver test can be used as a biomarker for the early diagnosis of hepatocellular carcinoma with a collection of samples from 58 patients diagnosed with HCC, 42 cirrhosis, 40 normal controls and the inclusion of 25-50 patients with chronic liver disease without cirrhosis.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Test Yliver
- Keywords
- Hepatocellular carcinoma, Tumor associated antigen, Early diagnosis, Autoantibodies, Alpha fetoprotein
- Medical subject headings
- Carcinoma, Hepatocellular, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test YliverDiagnostic test
Test Yliver is used to detect autoantibodies against alpha fetoprotein in serum by an ELISA technique
| Study group | Role | What they receive |
|---|---|---|
| HCC | Patients with diagnosis of Hepatocellular carcinoma Receives: Diagnostic Test: Test Yliver | |
| Cirrhosis | Patients with the diagnosis of cirrhosis who is following a screening program for diagnosis of HCC Receives: Diagnostic Test: Test Yliver | |
| Chronic liver diseases | Patients with the diagnosis of Chronic liver diseases without cirrhosis Receives: Diagnostic Test: Test Yliver | |
| Control | Normal human serum from donors without liver disease Receives: Diagnostic Test: Test Yliver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yliver
Titer of autoantibodies against alpha fetoprotein applying Taby Technology
Measured: October 2018-February 2019
Secondary outcomes (3)
AFP
Levels of alpha fetoprotein in serum
Measured: October 2018-February 2019
Ultrasound
Results of the ultrasound examination
Measured: October 2018-February 2019
AAb AFP
Titer of autoantibodies against alpha fetoprotein with standard protocol
Measured: October 2018-February 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start27 Dec 2018
- Primary completion1 Apr 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Francisco Delgado de la Poza, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03767764
- Sponsor's protocol ID
- CIR2017/024
- Acronym
- YliverDIAG
- Status last verified
- Jul 2021
- First submitted
- 5 Dec 2018
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yliver as a Test to Early Diagnose Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT03767764
- Acronym / sponsor ID
- YliverDIAG / CIR2017/024
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular carcinoma, Tumor associated antigen, Early diagnosis, Autoantibodies, Alpha fetoprotein
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 27 Dec 2018 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 7 Dec 2018 (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.
Liver cancer (HCC) is the second cause of death related to cancer worldwide, with about 750,000 deaths from this cause in 2012. Although the early diagnosis of liver cancer increases the available treatment options, the methods currently used for screening are not sufficiently sensitive for this purpose.
The investigators provide a high-performance and highly reliable in vitro platform that allows the identification and quantification of autoantibodies in serum for use as biomarkers of liver cancer, using an ELISA test (Yliver).
The aim of the study is to demonstrate whether the Yliver test can be used as a biomarker for the early diagnosis of hepatocellular carcinoma with a collection of samples from 58 patients diagnosed with HCC, 42 cirrhosis, 40 normal controls and the inclusion of 25-50 patients with chronic liver disease without cirrhosis.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HCC | – | Diagnostic Test: Test YliverPatients with diagnosis of Hepatocellular carcinoma |
| Cirrhosis | – | Diagnostic Test: Test YliverPatients with the diagnosis of cirrhosis who is following a screening program for diagnosis of HCC |
| Chronic liver diseases | – | Diagnostic Test: Test YliverPatients with the diagnosis of Chronic liver diseases without cirrhosis |
| Control | – | Diagnostic Test: Test YliverNormal human serum from donors without liver disease |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- HCC: patients with HCC diagnosis Cirrhosis: patients with liver cirrhosis diagnosis Chronic liver disease: patients with chronic liver diasease without cirrhosis Control: normal human serum from donors without liver disease
Key inclusion criteria (1 listed)
- EASL Clinical Practice Guidelines \& Practice Guidance by the American Association for the Study of Liver Diseases for diagnosis of HCC, liver cirrhosis, chronic hepatitis without cirrhosis
Key exclusion criteria (5 listed)
- Age under 18 years
- Very advanced disease (patient in a terminal state that is not indicated analytical determinations).
- Hepatic encephalopathy that prevents the correct understanding of informed consent.
- Refusal to carry out the determination or to sign the informed consent.
- Patients affected by another neoplastic disease
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 |
|---|---|---|
| Test YliverTest Yliver is used to detect autoantibodies against alpha fetoprotein in serum by an ELISA technique | Diagnostic test | Chronic liver diseases, Cirrhosis, Control, HCC |
Primary outcome
Yliver
Time frame: October 2018-February 2019
Titer of autoantibodies against alpha fetoprotein applying Taby Technology
3 secondary outcomes
AFP
Time frame: October 2018-February 2019
Ultrasound
Time frame: October 2018-February 2019
AAb AFP
Time frame: October 2018-February 2019
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 29 Jul 2021.
- Individual participant dataSharing planned: No
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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 Corporacion Parc Tauli at 1 site in Spain.
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 5 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 29 Jul 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 Spain. 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?
Yliver (time frame: October 2018-February 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2021.