A Prospective, Interventional, Longitudinal Asia Pacific Study Evaluating Clinical Utility of Des-gamma-carboxyprothrombin (PIVKA-II) or GAAD Score Plus Ultrasound for Detection of Hepatocellular Carcinoma (HCC) in a High-risk Patient Population
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 2,100
- 试验地点
- 2
- 主要终点
- Relative False Positive Rate of Surveillance Modalities
研究概览
简要总结
HCC surveillance is currently limited by underutilization and the suboptimal performance of AFP. This prospective, single-arm study investigates whether the GAAD score (Gender, Age, AFP, and PIVKA-II) enhances HCC detection when added to standard-of-care surveillance.
High-risk patients will undergo US plus GAAD score testing every six months for two years. The primary analysis compares the relative true positive rate (rTPR) and relative false positive rate (rFPR) of surveillance modalities (US, AFP, GAAD) against combined strategies (US+AFP; US+GAAD), utilizing a 2.57 GAAD cut-off. Secondary endpoints include longitudinal biomarker kinetics, early-stage HCC detection rates, and the impact on downstream imaging (CT/MRI) volume. Ultimately, this study seeks to define the role of GAAD as a surveillance adjunct and inform future clinical guidelines for biomarker-enhanced HCC screening.
详细描述
This is a prospective, non-randomized, open-label, interventional diagnostic utility study Study procedure Upon enrollment, patients will be followed for 2 years. Surveillance visits will take place at every 6 months intervals according to national guidelines and usual clinical practice. Biomarkers will be assessed using routine blood draw taken at each surveillance visit. Hence, no additional blood draw will be required as per study protocol. Blood collection will be conducted according to local's standard procedures.
The following parameters will be assessed at baseline and each follow-up visit.
- Characteristics (age, sex, height, weight)
- Blood test results (platelets, liver and kidney function, PT, viral infection, liver fibrosis markers)
- Fib4
- BMI
- Child-Pugh Score
- AFP, PIVKA, GAAD
- Ultrasound (US): liver evaluation, including existing liver steatosis and its degree if available (according to local clinical practice and used guidelines)
- Diabetes type (ICD-10)
- Dyslipidemia status
- Diagnostic of Hypertension
- Central obesity status (defined as waist more than 80 cm - women and 90 cm - male) The Elecsys® AFP, and Elecsys® PIVKA-II will be measured using the Elecsys analyzer, and the GAAD score for each case will be calculated using automatic calculation flow navifyTM Algo Suite.
- Elecsys® AFP and Elecsys® PIVKA will be tested and interpreted independent of GAAD as per investigators discretion and/or according to local clinical practice.
- GAAD - calculate using navify AlgoSuite In case of positive biomarker/score or imaging, result patients will be subjected further diagnostic workup (recall procedure) with multiphasic contrast-enhanced CT or MRI as described below.
Due to its better performance, MRI is the preferred modality but CT can be performed alternatively.
Recall procedure
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
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
- •Signed informed consent form (ICF).
- •Age above 18 years.
- •Patients with chronic liver disease who have an indication for HCC surveillance, including:
- •Liver cirrhosis of any etiology (e.g., chronic HBV, HCV, NASH, alcohol).
- •Non-cirrhotic chronic liver disease (HCV, MASH, ALD) with evidence of F3 stage fibrosis.
- •Chronic HBV infection with a clinical diagnosis of non-cirrhosis
排除标准
- •Diagnosis with any cancer other than non-melanoma skin cancer.
- •Pre-existing diagnosed malignancies, including previous HCC.
- •Life expectancy of less than 2 years.
- •Use of Vitamin K antagonists within one week before enrolment.
- •Women who are pregnant or lactating.
- •Glomerular filtration rate (GFR) < 60 mL/min/1.73 m².
- •Significant hepatic decompensation or a Child-Pugh score of C.
- •Unwillingness or inability to undergo CT and MRI imaging.
- •Unwillingness to participate in the study.
研究组 & 干预措施
Addition of PIVKA-II and GAAD score to all participants
Addition of PIVKA-II and GAAD score will probably detect more HCC and compare with ultrasound alone or ultrasound plus AFP
干预措施: PIVKA-II and GAAD score calculation (Diagnostic Test)
结局指标
主要结局
Relative False Positive Rate of Surveillance Modalities
时间窗: 24 months
Occurrence of hepatocellular carcinoma (HCC)
时间窗: 24 months of follow up
New HCC detected by imaging or pathology
Relative True Positive Rate of Surveillance Modalities
时间窗: 24 months
次要结局
未报告次要终点
研究者
Tawesak Tanwandee
Professor
Siriraj Hospital