NCT05064553进行中（未招募）不适用
ALTUS: Performance of a Multi- Target Hepatocellular Carcinoma (HCC) Test in Subjects With Increased Risk
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,990
- 试验地点
- 76
- 主要终点
- To demonstrate that Oncoguard™ Liver early-stage HCC sensitivity is non-inferior to that of ultrasound within a 5% margin
研究概览
简要总结
The primary objective is to assess overall sensitivity and specificity of Oncoguard™ Liver for hepatocellular cancer (HCC) detection in a surveillance population.
详细描述
The study will include participants aged 18 years and older who are at increased risk for HCC, including individuals with liver cirrhosis or non-cirrhotic individuals with chronic hepatitis B infection.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be 18 years of age or older.
- •Understand the study procedures, be able to provide written informed consent to participate in the study, and have authorization for release of data, including personal health data and images, to the study Investigator, Sponsor, and regulatory authorities.
- •Present for surveillance imaging due to increased risk for HCC, including either:
- •Diagnosis of cirrhosis based on at least one of the following:
- •Histology from a liver biopsy.
- •Ultrasound, CT, or MRI showing a cirrhotic liver combined with portal hypertension (as evidenced by the presence of intra-abdominal varices, or recanalized umbilical vein, or ascites or splenomegaly or thrombocytopenia [defined as Platelet count < 150,000]). The imaging results must have been obtained within 5 years of study enrollment.
- •Liver stiffness ≥4.71 kilopascal (kPa) by Magnetic Resonance (MR) elastography or ≥12.1 kPa by vibration controlled transient elastography.
- •Presence of varices on endoscopy or imaging and presence of a chronic liver disease. Endoscopy or imaging results must have been obtained within 5 years of study enrollment.
- •Non-cirrhotic subjects with chronic Hepatitis B Virus (HBV) infection (Hepatitis B surface antigen present for >6 months)
排除标准
- •Known cancer diagnosis (including active malignancy) within the past 5 years except for nonmelanoma skin cancer.
- •Chemotherapy and/or radiation therapy within 5 years prior to study enrollment.
- •Known Child-Pugh class C liver function at the time of enrollment, except for those on the waiting list for transplant.
- •Solid liver nodule >1 cm by ultrasound or elevated Alpha-fetoprotein (AFP) (>100 ng/mL) in 12 months preceding the qualifying surveillance imaging visit without subsequent documentation of HCC negative or LIRADS 1 (Liver Imaging Reporting and Data System) by diagnostic CT/MRI.
- •Females known to be pregnant at the time of enrollment.
- •Illness that the Investigator believes poses a significant risk of mortality during the study period, including but not limited to
- •Congestive heart failure with ejection fraction <50%
- •Chronic lung disease requiring supplemental oxygen.
- •History of recent stroke.
- •Sustained virologic response (SVR) for Hepatitis C Virus (HCV) (undetectable HCV RNA 12 to 24 weeks after completion of antiviral therapy) for >10 years prior to enrollment.
- •Not able to have IV contrast for CT or MRI due to
- •Allergy to IV contrast and unwilling or unable to receive IV contrast after pre-medication.
- •Estimated glomerular filtration rate <35 mL/min and not on hemodialysis.
结局指标
主要结局
To demonstrate that Oncoguard™ Liver early-stage HCC sensitivity is non-inferior to that of ultrasound within a 5% margin
时间窗: A maximum of 30 days from study or standard-of-care CT or MRI exam.
To demonstrate that Oncoguard™ Liver HCC specificity exceeds 82%
时间窗: A maximum of 30 days from study or standard-of-care CT or MRI exam.
次要结局
- To determine a point estimate and 95% confidence interval for Oncoguard™ Liver overall HCC sensitivity(A maximum of 30 days from study or standard-of-care CT or MRI exam.)
研究者
研究点 (76)
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