Seravue Validation Study for Liver Cancer Diagnosis
This study is testing a new diagnostic tool called Seravue for detecting liver cancer (Hepatocellular Carcinoma or HCC). Currently, ultrasound and a blood test called AFP are used, but they aren't always accurate enough, especially in early stages. Researchers want to see if Seravue, either alone or with ultrasound, can better identify HCC in people aged 21 to 84. The study will compare Seravue's performance against current methods over 24 months. This is an observational study, meaning you won't receive a new treatment, but your health will be monitored to see how well Seravue works.
- Study design
- This is an observational study planning to enroll 1392 participants. It will compare the Seravue device to standard methods for detecting liver cancer.
- What's involved
- You would have baseline assessments and blood draws, plus hepatic ultrasound and AFP testing at enrollment, 6, 12, and 18 months, or until HCC diagnosis. Your medical records will be reviewed at 24 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 24 months from enrollment, or until an HCC diagnosis is confirmed.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Seravue Validation Study for Hepatocellular Carcinoma (HCC) Diagnosis
At a glance
Conditions
NCT06994130
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Beth Israel Deaconess Medical Center
Boston, Massachusettsstudy coordinator listed
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Primary ObjectiveFrom enrollment to the end of study 24 months
The primary objective of the study is to test that the sensitivity of the SeravueTM test in conjunction with ultrasound (LC-SPIK+US) is higher compared to a point-estimate of the sensitivity of the standard of care (US+AFP) in detecting HCC for patients with high risk of HCC due to chronic HBV or hepatic cirrhosis while the specificity are similar