HCCBloodTest for Detection of Hepatocellular Carcinoma (HCC)
1 other identifier
observational
175
1 country
2
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2018
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 17, 2018
CompletedFirst Submitted
Initial submission to the registry
January 11, 2019
CompletedFirst Posted
Study publicly available on registry
January 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2019
CompletedJanuary 30, 2020
January 1, 2020
10 months
January 11, 2019
January 28, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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.
45 days
Study Arms (2)
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.
Eligibility Criteria
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.
You may qualify if:
- 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:
- 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.
You may not qualify if:
- 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;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Epigenomics, Inclead
- Innovis LLCcollaborator
Study Sites (2)
USC Keck Medical Center
Los Angeles, California, 90033, United States
California Liver Research Institute
Pasadena, California, 91105, United States
Related Publications (1)
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.
PMID: 33765926DERIVED
Biospecimen
De-identified, clinically characterized plasma specimens for a bio-repository will be retained for up to twenty (20) years for future HCC-related test development.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Theo DeVos
Epigenomics, Inc
- STUDY DIRECTOR
Nick Potter
Epigenomics, Inc
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2019
First Posted
January 15, 2019
Study Start
December 17, 2018
Primary Completion
October 1, 2019
Study Completion
October 31, 2019
Last Updated
January 30, 2020
Record last verified: 2020-01