Clinical trial · Observational
Performance Evaluation (Sensitivity/Specificity) of HelioLiver Test for Detection of HCC
Specimen Collection for Multi-Analyte Blood-Test for Hepatocellular Carcinoma
NCT05059665CI-TRIAL-00054902ENCOREcompletedClinicalTrials.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)
De-identified whole blood and serum samples are collected for the purpose of evaluating the performance (sensitivity/specificity) of the HelioLiver Test for the detection of hepatocellular carcinoma (HCC).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma by AJCC Stage | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Helio Liver Test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- HCC Subjects
- description
- All subjects will be recently diagnosed with hepatocellular carcinoma as defined by at least one of the following criteria: * Subject has a ≥1 cm lesion exhibiting arterial phase hyperenhancement in combination with washout appearance by MRI and/or CT. * Subject has a lesion of any size indicated to be HCC due to capsule appearance by 4 phase CT scan and/or multiphase contrast enhanced MRI. * Subjects with a suspicious lesion of less than 2 cm must have HCC confirmed by both MRI and CT. * Subject has a biopsy that is positive for HCC. * Diagnostic imaging by multiphasic MRI or CT indicates a suspicious lesion on the liver, which is subsequently confirmed to be HCC by another method (biopsy, or surgical pathology).
- interventionNames
- Diagnostic Test: Helio Liver Test
- label
- Surveillance Subjects
- description
- At-risk subjects with chronic liver disease undergoing routine imaging surveillance for HCC.
- interventionNames
- Diagnostic Test: Helio Liver Test
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 Years and Older (Adult, Older Adult) Exclusion Criteria: * None
References
Publications (0)
Data not yet available
No reference posted for this study.