A Prospective Evaluation of Seravue Device Sensitivity and Specificity for Surveillance and Diagnosis of Patients at Risk for Hepatocellular Carinoma (HCC)
ImCare Biotech
Summary
Currently, ultrasound with or without AFP is the standard of care when it comes to surveillance for HCC in high-risk populations. While ultrasound is non-invasive and plays a critical role in detecting HCC, it is operator-dependent, inconvenient, and may have access issues in low-resource settings. Most critically, ultrasound is not sensitive enough to detect or confirm HCC in its most critical early stages, where treatment options are most effective and result in the best patient outcomes. AFP on the other hand, suffers from poor sensitivity and specificity generally, and its performance is insufficient for use as a surveillance tool. There remains a clear unmet need for a blood test that is sensitive enough to detect HCC in its early stages while being cost-effective and accessible for use as a surveillance tool. The investigators have previously demonstrated that serum liver cancer-secreted serine protease inhibitor Kazal (LC-SPIK) can reliably detect early HCC in addition to differentiating between it and other liver diseases. This study seeks to test the performance of the Seravue (LC-SPIK) device alone or in combination with other HCC diagnostic tests as a tool for HCC surveillance in diverse patient populations and clinical settings.
Description
Patients who meet eligibility criteria and provide written informed consent will undergo comprehensive screening evaluations and standard of care clinical laboratory tests, including hepatic ultrasound and AFP testing at baseline, 6, 12, and 18 months after enrollment, or until the diagnosis of HCC. At each visit, blood specimens will be collected for testing with the Seravue device and for clinical and study biomarker testing including AFP. Pateints negative for ultrasound, AFP or Seravue results will continue on with the study. Patient testing positive for ultrasound, or AFP test results wil…
Eligibility
- Age range
- 21–84 years
- Sex
- All
- Healthy volunteers
- No
INCLUSION/EXCLUSION CRITERIA: Patients who provide written informed consent and meet eligibility criteria will undergo baseline assessments and be entered into the study. Inclusion Criteria: A patient must meet all of the following criteria to be eligible for this study: 1. The patient is willing and able to provide signed informed consent. 2. The patient is aged ≥21to ≤84 years. 3. The patient is willing to undergo phlebotomy and provide blood samples for future biomarker analysis. 4. The patient is willing and able to undergo regularly scheduled onsite liver cancer surveillance by ultras…
Interventions
- Diagnostic TestSeravue
. This study seeks to test the performance of the SeravueTM (LC-SPIK) device alone or in combination with ultrasound as a tool for HCC surveillance in diverse patient populations and clinical settings.
Location
- Beth Israel Deaconess Medical CenterBoston, Massachusetts