Surveillance and Treatment Of Primary Hepatocellular Carcinoma: An International Cohort Study of High-Risk Patients for HCC Using Liquid Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 360
- 试验地点
- 10
- 主要终点
- GALAD performance for liver cancer early detection
研究概览
简要总结
This study has two purposes. One is to conduct a phase IV biomarker validation study in which the investigators will prospectively survey a cohort of patients at risk for liver cancer using semi-annual abdominal ultrasound and GALAD Score for 5 years. The GALAD score is a serum biomarker-based panel that can aid in early detection among patients with a high risk for liver cancer. One is to establish a bio-repository of longitudinally collected bio-specimens from patients with fibrosis/cirrhosis as a reference set for future research.
详细描述
Vietnam and Saudi Arabia have some of the highest disease burdens of liver cancer globally. Early detection in asymptomatic patients who are at risk for liver is a strategy to improve survival outcomes in liver cancer management. GALAD score (gender, age, alpha-feto protein (AFP)-L%, AFP and DCP) is a serum biomarker-based panel that can improve HCC early detection in patients with liver fibrosis and cirrhosis. In case-control studies and studies with the design of prospective specimen collection, and retrospective blinded evaluation, GALAD has demonstrated promising clinical utility. However, in order to ascertain its potential role in the surveillance of liver cancer early detection, GALAD needs to be validated prospectively for clinical surveillance of liver cancer (i.e. phase IV biomarker validation study). Thus, the investigators propose to conduct a phase IV biomarker validation study to prospectively survey a cohort of patients at risk for HCC (i.e. patients with compensated cirrhosis and irrespective of cirrhosis etiologies), using semi-annual abdominal ultrasound and GALAD Score for 5 years. In doing so, the investigators aim to validate the potential role of GALAD Score for clinical surveillance and early detection of HCC in Vietnam and Saudi Arabia. Additionally, the investigators will collect and archive biospecimens to develop a bio-repository for liver disease. The biorepository will encourage the sharing of biospecimens and collaboration among physicians or physician-researchers between the US, Vietnam, and Saudi Arabia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study and up to 5 years post-study follow up
- •Adults aged 18 or older
- •Both genders and all ethnicities
- •Willingness to give written, informed consent to be enrolled into the database
- •Collection of biosamples (serum, plasma, and urine) at each of the 6 months follow up during the study duration
- •Individuals already confirmed to have cirrhosis with MELD ≤ 15 from any etiology (chronic HBV, chronic HCV, NASH cirrhosis, etc.)
- •For chronic HBV and/or /HCV carrier, with or without on treatment
- •Reside in Vietnam or Saudi Arabia at the time of study and provides contact information (email and/or cell phone number for texting)
- •No prior or current treatment of HCC
- •No cancer history within 5 years
- •No participation in a trial for HCC Treatment
- •No prior solid organ transplant
- •Albumin, Bilirubin, Creatinine and INR labs within past 30 days
- •Imaging showing no HCC within 180 days
- •Diagnosis of fibrosis and cirrhosis based on: histology, image showing cirrhotic liver with splenomegaly and platelets <120 mm3, or esophageal or gastric varices on endoscopy AND presence of chronic liver disease/Fibroscan/Fib-4/APRI/ARFI. For viral hepatitis, kPa>=9kPa, APRI >=1; for NAFLD/NASH (FIB-4 > 1.3 & TE > 8kPa)
- •No significant hepatic decompensation
- •No hepatorenal syndrome
- •AFP labs within 180 days irrespective of AFP titer
- •Two phone numbers and personal identification numbers (CMND number)
- •No known AIDS related diseases
- •No significant co-morbid conditions with life expectancy <5 years
- •No other cancer(s)
排除标准
- •Decompensated cirrhosis (variceal bleeding, hepatic encephalopathy, ascites, spontaneous bacterial peritonitis, and/or hepatorenal syndrome) or MELD>15
- •Individuals who already have HCC, with or without HCC treatment
- •On liver transplantation list or anticipated to be on the liver transplantation list during the study duration
- •Individuals who cannot, do not want to, or refused to sign the informed consent form (ICF)
- •Any serious or active medical or psychiatric illness, which, in the opinion of the investigator, would interfere with patient treatment, assessment or compliance with the protocol
- •Documentation was not adequate
- •Taking Vitamin K within 7 days prior to clinic follow or having disease affecting Vitamin K levels.
- •Known HIV positive
- •Active drug use or dependence that, in the opinion of the study investigator, would interfere with adherence to study requirements
结局指标
主要结局
GALAD performance for liver cancer early detection
时间窗: 5 years
Performance of GALAD score determined in association with liver cancer detection by LiRADS criteria in a cohort with compensated cirrhosis undergoing prospective surveillance every 6 months for 5 years.
次要结局
- Establishment of a bio-repository of longitudinally collected from patients with cirrhosis to be used for future studies(5 years)