Cirrhosis, LiverNCT03804593
HCCBloodTest for Detection of Hepatocellular Carcinoma (HCC)
An observational study of Cirrhosis, Liver and Hepatic Cirrhosis, run by Epigenomics, Inc at 2 sites in United States.
Trial summary
This is a multi-center study to prospectively gather clinically-characterized plasma samples to determine the diagnostic performance characteristics (sensitivity and specificity) of the HCCBloodTest among patients with cirrhosis with and without HCC Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Liver, Hepatic Cirrhosis, Hepatocellular Carcinoma
- How many people
- 175 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Dec 2018to 31 Oct 2019
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Eligible subjects will be men and women age 18 years or older. Study will enroll sufficient subjects to yield a minimum of 100 evaluable subjects in Group 1, a minimum of 100 evaluable subjects with de novo HCC and cirrhosis in Group 2 and up to 20 subjects with de novo HCC without cirrhosis in Group 2 - a total of up to 220 evaluable study subjects who meet all inclusion and exclusion criteria for these two groups.
Who may be able to join
- Men or women age 18 years or older;
- Able to read, understand and sign informed consent to participate in study;
- Willing and able to provide written informed consent;
- Willing and able to meet all study requirements and undergo venipuncture to provide blood samples;
- Child-Pugh Score of A or B.
- Group 1:
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- Diagnosis of cirrhosis and no HCC confirmed by abdominal contrast-enhanced MRI or CT study performed < 90 days prior to the date of consent or an MRI performed ≤ 45 days after Visit 1. If lesions are present, a LI-RADS score of LR-1 or LR-2.
- Group 2:
- Diagnosis of HCC confirmed by abdominal contrast-enhanced MRI or CT study performed < 90 days prior to the date of consent or an MRI performed ≤ 45 days after Visit 1 with LI-RADS score of LR-5 and/or biopsy with histopathology.
Who cannot join
- Both Groups:
- Child-Pugh Score of C;
- Subject has undergone a colonoscopy, endoscopy or other invasive diagnostic procedure (other than venipuncture) during the 10 days prior to providing a blood sample for this study;
- Pregnancy;
- Breastfeeding;
- Currently undergoing dialysis;
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- Currently receiving investigational treatments of any type;
- History of receiving any drug therapy, surgery or liver transplant for the treatment of HCC;
- Diagnosis of any non-HCC cancer (other than non-melanoma skin cancer) within past 5 years and/or currently undergoing treatment for any cancer;
- Any clinical condition, diagnosis, or social circumstance that, in the opinion of the Investigator, would be mean participation in the study would be contraindicated.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
USC Keck Medical Center
Los Angeles, California, 90033
California Liver Research Institute
Pasadena, California, 91105
About this study
Official title: HCCBloodTest for Detection of Hepatocellular Carcinoma (HCC): Marker Performance Validation and Technical Development Study
This is a multi-center study to prospectively gather clinically-characterized plasma samples to determine the diagnostic performance characteristics (sensitivity and specificity) of the HCCBloodTest among patients with cirrhosis with and without HCC
Read the detailed description
Patients with clinically-diagnosed cirrhosis without HCC (Group 1) and patients with early-stage HCC (Group 2) will be invited to participate in this study consisting of one visit for all subjects. At Visit 1, Day 0, after subjects have provided informed consent and HIPAA consent, demographics (age, gender, ethnicity), etiology of liver disease and medical history as well as a list of current medications will be obtained; inclusion and exclusion criteria will be reviewed; and subjects will be registered into the study and will undergo a venipuncture to obtain four (4) lavender top K2 ethylenediaminetetraacetic acid (EDTA) 10 millilitre (mL) tubes of blood.
The HCCBloodTest will be performed on the blood samples collected from study subjects by the Sponsor at its laboratory in Berlin, Germany, to determine the performance characteristics of the HCCBloodTest in the study population.
The HCCBloodTest is an in-vitro polymerase chain reaction (PCR) assay for the qualitative detection of Septin 9 gene methylation (SEPT9) in DNA isolated from 3.5 mL of patient plasma. The SEPT9 gene is a key regulator of cell division and tumor suppressor and the hypermethylation of the assessed marker site is associated with liver carcinogenesis.
Results from the HCCBloodTest will be not be provided to the investigators or study subjects and, therefore, will be not be used in clinical decision-making or impact clinical care of the study participants in any manner.
- Medical subject headings
- Liver Cirrhosis, Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Diagnosis of cirrhosis and no HCC confirmed by medical imaging including MRI or CT performed within 6 months of study enrollment. If lesions are present, a Liver Imaging Reporting and Data System (LI-RADS) score of LR-1 or LR-2. | |
| Group 2 | Diagnosis of HCC confirmed by medical imaging (MRI or CT performed within 6 months of study enrollment with LI-RADS score of LR-5) and/or biopsy with histopathology. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of SEPT9 gene promoter methylation positivity in patients with cirrhosis, based on the HCCBloodTest.
The HCCBloodTest is an in-vitro PCR based assay for the qualitative detection of the methylation status of a SEPT9 gene promoter DNA sequence. Plasma will be prepared from blood samples collected from study subjects and will be tested by the Sponsor with HCCBloodTest at its laboratory in Berlin, Germany. Positivity based on PCR results will be reported for study subjects. Test performance characteristics including sensitivity and specificity will be reported for the study population.
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start17 Dec 2018
- Primary completion1 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cirrhosis, LiverStudies 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
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epigenomics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Innovis LLC
- Responsible party
- Sponsor
- Investigators
- Theo DeVos, Study director, Epigenomics, IncNick Potter, Study director, Epigenomics, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03804593
- Sponsor's protocol ID
- Epigenomics 2018-HCC-A
- Status last verified
- Jan 2020
- First submitted
- 11 Jan 2019
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lewin J, Kottwitz D, Aoyama J, deVos T, Garces J, Hasinger O, Kasielke S, Knaust F, Rathi P, Rausch S, Weiss G, Zipprich A, Mena E, Fong TL. Plasma cell free DNA methylation markers for hepatocellular carcinoma surveillance in patients with cirrhosis: a case control study. BMC Gastroenterol. 2021 Mar 25;21(1):136. doi: 10.1186/s12876-021-01714-8.
PubMed 33765926
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HCCBloodTest for Detection of Hepatocellular Carcinoma (HCC): Marker Performance Validation and Technical Development Study
- ClinicalTrials.gov ID
- NCT03804593
- Acronym / sponsor ID
- Epigenomics 2018-HCC-A
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Epigenomics, IncIndustry (pharma, biotech, devices)
- Collaborators
- Innovis LLC
- Study start
- 17 Dec 2018 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 15 Jan 2019 (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 is a multi-center study to prospectively gather clinically-characterized plasma samples to determine the diagnostic performance characteristics (sensitivity and specificity) of the HCCBloodTest among patients with cirrhosis with and without HCC
Detailed description
Patients with clinically-diagnosed cirrhosis without HCC (Group 1) and patients with early-stage HCC (Group 2) will be invited to participate in this study consisting of one visit for all subjects. At Visit 1, Day 0, after subjects have provided informed consent and HIPAA consent, demographics (age, gender, ethnicity), etiology of liver disease and medical history as well as a list of current medications will be obtained; inclusion and exclusion criteria will be reviewed; and subjects will be registered into the study and will undergo a venipuncture to obtain four (4) lavender top K2 ethylenediaminetetraacetic acid (EDTA) 10 millilitre (mL) tubes of blood.
The HCCBloodTest will be performed on the blood samples collected from study subjects by the Sponsor at its laboratory in Berlin, Germany, to determine the performance characteristics of the HCCBloodTest in the study population.
The HCCBloodTest is an in-vitro polymerase chain reaction (PCR) assay for the qualitative detection of Septin 9 gene methylation (SEPT9) in DNA isolated from 3.5 mL of patient plasma. The SEPT9 gene is a key regulator of cell division and tumor suppressor and the hypermethylation of the assessed marker site is associated with liver carcinogenesis.
Results from the HCCBloodTest will be not be provided to the investigators or study subjects and, therefore, will be not be used in clinical decision-making or impact clinical care of the study participants in any manner.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Diagnosis of cirrhosis and no HCC confirmed by medical imaging including MRI or CT performed within 6 months of study enrollment. If lesions are present, a Liver Imaging Reporting and Data System (LI-RADS) score of LR-1 or LR-2. |
| Group 2 | – | –Diagnosis of HCC confirmed by medical imaging (MRI or CT performed within 6 months of study enrollment with LI-RADS score of LR-5) and/or biopsy with histopathology. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible subjects will be men and women age 18 years or older. Study will enroll sufficient subjects to yield a minimum of 100 evaluable subjects in Group 1, a minimum of 100 evaluable subjects with de novo HCC and cirrhosis in Group 2 and up to 20 subjects with de novo HCC without cirrhosis in Group 2 - a total of up to 220 evaluable study subjects who meet all inclusion and exclusion criteria for these two groups.
Key inclusion criteria (9 listed)
- Men or women age 18 years or older;
- Able to read, understand and sign informed consent to participate in study;
- Willing and able to provide written informed consent;
- Willing and able to meet all study requirements and undergo venipuncture to provide blood samples;
- Child-Pugh Score of A or B.
Key exclusion criteria (10 listed)
- Child-Pugh Score of C;
- Subject has undergone a colonoscopy, endoscopy or other invasive diagnostic procedure (other than venipuncture) during the 10 days prior to providing a blood sample for this study;
- Pregnancy;
- Breastfeeding;
- Currently undergoing dialysis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of SEPT9 gene promoter methylation positivity in patients with cirrhosis, based on the HCCBloodTest.
Time frame: 45 days
The HCCBloodTest is an in-vitro PCR based assay for the qualitative detection of the methylation status of a SEPT9 gene promoter DNA sequence. Plasma will be prepared from blood samples collected from study subjects and will be tested by the Sponsor with HCCBloodTest at its laboratory in Berlin, Germany. Positivity based on PCR results will be reported for study subjects. Test performance characteristics including sensitivity and specificity will be reported for the study population.
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 30 Jan 2020.
- Derived from this study: PubMed 33765926Lewin J, Kottwitz D, Aoyama J, deVos T, Garces J, Hasinger O, Kasielke S, Knaust F, Rathi P, Rausch S, Weiss G, Zipprich A, Mena E, Fong TL. Plasma cell free DNA methylation markers for hepatocellular carcinoma surveillance in patients with cirrhosis: a case control study. BMC Gastroenterol. 2021 Mar 25;21(1):136. doi: 10.1186/s12876-021-01714-8.
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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.
Theo DeVos study director
Epigenomics, Inc
Nick Potter study director
Epigenomics, Inc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis, Liver and Hepatic Cirrhosis, run by Epigenomics, Inc at 2 sites in United States.
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 9 inclusion and 10 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 30 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Rate of SEPT9 gene promoter methylation positivity in patients with cirrhosis, based on the HCCBloodTest. (time frame: 45 days). 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 NCT03804593, which also lists 1 linked publication.
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 30 Jan 2020.