Hepatocellular CarcinomaNCT04264754
Characterization of Methylation Patterns in Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma and Hepatocellular Cancer, run by Nucleix Ltd. at 5 sites in Israel.
Trial summary
This study is being performed as part of the development process of the Liver EpiCheck test which includes the identification of different methylation profiles in HCC (hepatocellular carcinoma) patients compare to cancer free control in blood samples Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Hepatocellular Cancer, Cirrhosis
- What is being tested?
- Blood collection
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 5 sitesIsrael
- Study dates
- 13 Feb 2018to 1 Feb 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who have already been diagnosed with liver cancer, however did not yet undergo any surgery, ablation, embolization or any other treatment for this cancerous lesion (including, but not limited to systemic therapies) will be enlisted into the study as the Case group. In addition, blood samples will be obtained from participants without cancer, who are considered in high risk for HCC; those subjects will be recruited from outpatient units or from Health Management Organization involved in routine surveillance for HCC in high risk subjects.
Who may be able to join
- Age ≥ 22 years
- Subjects who are willing and able to provide written informed consent
- Subjects with confirmed diagnosis of HCC, naïve to tumor directed therapy
- Age ≥ 22 years
- Subjects who are willing and able to provide written informed consent
- Subjects diagnosed with one of the following:
Show all 10Show fewer
- Subjects with HCV and cirrhosis ii. Subjects with HBV and cirrhosis iii. Non-cirrhotic chronic HBV subjects at intermediate or high risk of HCC, according to EASL Clinical Practice Guidelines for the management of hepatocellular carcinoma iv. Subjects with Non-Alcoholic Fatty Liver Disease (NAFLD) with cirrhosis. v. Cirrhotic patients due to any other reasons, including alcohol disease
- Subjects currently undergoing surveillance for hepatocellular carcinoma
- HCC surveillance imaging (e.g., US, CT, MRI) performed within 3 months prior to baseline visit
- Subjects with compensated liver function as measured by Child-Pugh Score A or B7 without ascites (all measures should be from the last three months)
Who cannot join
- Subjects with current cancer of any kind, other than hepatocellular carcinoma
- Subjects with a history of cancer of any kind (including hepatocellular carcinoma), other than non-melanoma skin cancer completely resected
- Coinfection with HIV
- Prior solid organ transplant
- Subjects with current cancer of any kind, other than hepatocellular carcinoma
- Subjects with a history of cancer of any kind (including hepatocellular carcinoma), other than non-melanoma skin cancer completely resected
Show all 9Show fewer
- Coinfection with HIV
- Prior solid organ transplant
- Current substance abuse
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Israel5 sites
Ha'emek Medical Center
Afula
Carmel Medical Center
Haifa
Rambam Medical Center
Haifa
Sheba Medical Center
Ramat Gan
Tel Aviv Sourasky Medical Center
Tel Aviv
About this study
This study is being performed as part of the development process of the Liver EpiCheck test which includes the identification of different methylation profiles in HCC (hepatocellular carcinoma) patients compare to cancer free control in blood samples
Read the detailed description
This is a prospective, multi-center, observational study aimed to collect blood samples and de-identified clinical data from subjects diagnosed with HCC (cases arm) and subjects with high risk for HCC which are undergoing routine surveillance for HCC.
- Conditions
- Hepatocellular Carcinoma, Hepatocellular Cancer, Cirrhosis
- Being tested
- Blood collection
- Keywords
- Cirrhosis, Hepatocellular Carcinoma, Methylation, HCC
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collectionProcedure or surgery
Peripheral blood will be collected via routine venipuncture procedure
| Study group | Role | What they receive |
|---|---|---|
| Cases Group | Subjects who have already been diagnosed with liver cancer, however did not yet undergo any surgery, ablation, embolization or any other treatment for this cancerous lesion (including, but not limited to systemic therapies) Receives: Procedure: Blood collection | |
| Control Group | Cancer free subjects with high risk to development HCC. High risk subjects include the following:
1. Subjects with HCV (hepatitis C virus) and cirrhosis
2. Subjects with HBV (hepatitis B virus) and cirrhosis
3. Non-cirrhotic chronic HBV subjects at intermediate or high risk of HCC, according to EASL (European Association for the Study of the Liver) Clinical Practice Guidelines for the management of hepatocellular carcinoma
4. Subjects with NAFLD (Non-Alcoholic Fatty Liver Disease) with cirrhosis
5. Cirrhotic patients due to any other reasons, including alcohol disease Receives: Procedure: Blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
To collect blood samples and clinical data in order to characterize methylation patterns that will discriminate between HCC and normal hepatic tissue
To collect blood samples and clinical data in order to characterize methylation patterns that will discriminate between HCC and normal hepatic tissue
Measured: 60 months
To develop a molecular blood test that will be able to detect HCC based on change in methylation patterns between HCC and normal hepatic tissue
To develop a molecular blood test that will be able to detect HCC based on change in methylation patterns between HCC and normal hepatic tissue
Measured: 60 months
Secondary outcomes (1)
Liver EpiCheck Performance
To assess the performance of the Liver EpiCheck in terms of (1) Sensitivity (2) Specificity (3) NPV(negative predictive value) and (4) PPV (positive predictive value)
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start13 Feb 2018
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Why it stopped: Sponsor prioritize other clinical projects over this study
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
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nucleix Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04264754
- Sponsor's protocol ID
- Liver-RND-001
- Status last verified
- May 2021
- First submitted
- 9 Feb 2020
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be share with other researchers. The statistical analysis will be performed by the study sponsor
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Methylation Patterns in Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT04264754
- Acronym / sponsor ID
- Liver-RND-001
- Conditions
- Hepatocellular Carcinoma, Hepatocellular Cancer, Cirrhosis
- Keywords
- Cirrhosis, Hepatocellular Carcinoma, Methylation, HCC
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor prioritize other clinical projects over this study
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Nucleix Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Feb 2018 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 11 Feb 2020 (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.
This study is being performed as part of the development process of the Liver EpiCheck test which includes the identification of different methylation profiles in HCC (hepatocellular carcinoma) patients compare to cancer free control in blood samples
Detailed description
This is a prospective, multi-center, observational study aimed to collect blood samples and de-identified clinical data from subjects diagnosed with HCC (cases arm) and subjects with high risk for HCC which are undergoing routine surveillance for HCC.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases Group | – | Procedure: Blood collectionSubjects who have already been diagnosed with liver cancer, however did not yet undergo any surgery, ablation, embolization or any other treatment for this cancerous lesion (including, but not limited to systemic therapies) |
| Control Group | – | Procedure: Blood collectionCancer free subjects with high risk to development HCC. High risk subjects include the following: 1. Subjects with HCV (hepatitis C virus) and cirrhosis 2. Subjects with HBV (hepatitis B virus) and cirrhosis 3. Non-cirrhotic chronic HBV subjects at intermediate or high risk of HCC, according to EASL (European Association for the Study of the Liver) Clinical Practice Guidelines for the management of hepatocellular carcinoma 4. Subjects with NAFLD (Non-Alcoholic Fatty Liver Disease) with cirrhosis 5. Cirrhotic patients due to any other reasons, including alcohol disease |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who have already been diagnosed with liver cancer, however did not yet undergo any surgery, ablation, embolization or any other treatment for this cancerous lesion (including, but not limited to systemic therapies) will be enlisted into the study as the Case group. In addition, blood samples will be obtained from participants without cancer, who are considered in high risk for HCC; those subjects will be recruited from outpatient units or from Health Management Organization involved in routine surveillance for HCC in high risk subjects.
Key inclusion criteria (10 listed)
- Age ≥ 22 years
- Subjects who are willing and able to provide written informed consent
- Subjects with confirmed diagnosis of HCC, naïve to tumor directed therapy
- Age ≥ 22 years
- Subjects who are willing and able to provide written informed consent
Key exclusion criteria (9 listed)
- Subjects with current cancer of any kind, other than hepatocellular carcinoma
- Subjects with a history of cancer of any kind (including hepatocellular carcinoma), other than non-melanoma skin cancer completely resected
- Coinfection with HIV
- Prior solid organ transplant
- Subjects with current cancer of any kind, other than hepatocellular carcinoma
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 |
|---|---|---|
| Blood collectionPeripheral blood will be collected via routine venipuncture procedure | Procedure or surgery | Cases Group, Control Group |
Primary outcome
To collect blood samples and clinical data in order to characterize methylation patterns that will discriminate between HCC and normal hepatic tissue
Time frame: 60 months
To collect blood samples and clinical data in order to characterize methylation patterns that will discriminate between HCC and normal hepatic tissue
To develop a molecular blood test that will be able to detect HCC based on change in methylation patterns between HCC and normal hepatic tissue
Time frame: 60 months
To develop a molecular blood test that will be able to detect HCC based on change in methylation patterns between HCC and normal hepatic tissue
1 secondary outcome
Liver EpiCheck Performance
Time frame: 60 months
Results and safety
The study was stopped early (reason given: Sponsor prioritize other clinical projects over this study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Individual participant dataSharing planned: No. No IPD will be share with other researchers. The statistical analysis will be performed by the study sponsor
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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.
5 sites 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 and Hepatocellular Cancer, run by Nucleix Ltd. at 5 sites in Israel.
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 10 inclusion and 9 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: stopped early, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Israel. 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 was stopped early (reason given: Sponsor prioritize other clinical projects over this study). Results are not available in the source record.
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?
To collect blood samples and clinical data in order to characterize methylation patterns that will discriminate between HCC and normal hepatic tissue (time frame: 60 months). The study lists 2 primary outcomes in all. 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 6 May 2021.