Clinical trial · Observational
HCCBloodTest for Detection of Hepatocellular Carcinoma (HCC)
HCCBloodTest for Detection of Hepatocellular Carcinoma (HCC): Marker Performance Validation and Technical Development Study
NCT03804593CI-TRIAL-00043095completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cirrhosis, Liver | — | UNRESOLVED | — |
| Hepatic Cirrhosis | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Group 1
- description
- 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.
- label
- Group 2
- description
- 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.
Primary outcomes (1)
- measure
- Rate of SEPT9 gene promoter methylation positivity in patients with cirrhosis, based on the HCCBloodTest.
- timeFrame
- 45 days
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: 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.
References
Publications (1)
- DERIVEDLewin 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 33765926