Project for Multi-Omics-Based Early Detection of Hepatocellular Carcinoma (PROMETHEA Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Sensitivity
研究概览
简要总结
Hepatocellular carcinoma (HCC) is often diagnosed at an advanced stage, and early detection is critical for improving patient outcomes. Despite this, reliable non-invasive biomarkers for early-stage HCC are limited.
This study seeks to develop a multi-omics-based liquid biopsy assay, especially focusing on ncRNAs (e.g. tsRNA, miRNA, circRNA, lncRNA, etc.) for accurate detection of early-stage HCC.
详细描述
Liver cancer is a major global health challenge, ranking as the 5th leading cause of cancer-related deaths in the U.S. and 3rd worldwide, with hepatocellular carcinoma (HCC) accounting for ~75% of cases. Incidence has more than tripled since 1980, and death rates have risen by ~2% annually, highlighting the need for improved detection and treatment. Prognosis remains poor: over 50% of HCC cases are diagnosed at stage IV, with a 1-year survival below 30%, whereas early-stage HCC (stages I-II) can achieve up to 74% 5-year survival with curative interventions. Major risk factors include viral hepatitis (HBV, HCV), alcohol abuse, obesity, type 2 diabetes, and non-alcoholic fatty liver disease (NAFLD), with non-viral HCC increasing in prevalence, particularly in Western countries. Screening programs target high-risk populations but miss many asymptomatic or average-risk individuals, contributing to late-stage diagnoses.
Biomarker discovery holds promise for improving early detection. Alpha-fetoprotein (AFP), the most widely used biomarker, has limited sensitivity for early-stage HCC (39-64%).
This study seeks to validate a panel of more accurate and non-invasive biomarkers in preoperative blood samples. Accurate early detection of HCC would help provide clear criteria for treatment decisions, such as timely surgical intervention or the addition of adjuvant chemotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 to 100 years.
- •A histologically confirmed diagnosis of hepatocellular carcinoma.
- •A clinically diagnosed as chronic liver disease, including chronic hepatitis or liver cirrhosis, without evidence of hepatocellular carcinoma.
- •Healthy volunteers without known liver disease or malignancy.
- •Received standard diagnostic and staging procedures as per local guidelines
- •Availability of blood or other biospecimens.
- •Ability to provide written informed consent.
排除标准
- •Lack of or inability to provide informed consent
- •History of other active malignancies within the past 5 years
- •Previous liver transplantation
- •Severe systemic infection or inflammatory disease at the time of enrollment
- •Inadequate sample quality or quantity
研究组 & 干预措施
Healthy Controls
Healthy individuals without known liver disease or malignancy who will provide blood or other biospecimens as normal controls for biomarker evaluation.
干预措施: Small RNA sequence (Diagnostic Test)
HCC (Discovery, Small RNA-seq)
Patient diagnosed with hepatocellular carcinoma, including cases with HBV-, HCV-, and NBNC-related etiologies. Blood or other biospecimens will be collected for multi-omics profiling
干预措施: Small RNA sequence (Diagnostic Test)
HCC (Discovery, Small RNA-seq)
Patient diagnosed with hepatocellular carcinoma, including cases with HBV-, HCV-, and NBNC-related etiologies. Blood or other biospecimens will be collected for multi-omics profiling
干预措施: Rt-qPCR (Diagnostic Test)
Chronic Liver Disease (CLD) cohort
Patients with chronic liver disease, including liver cirrhosis and chronic hepatitis, without evidence of hepatocellular carcinoma.
Blood or other biospecimens will be collected for multi-omics profiling.
干预措施: Small RNA sequence (Diagnostic Test)
Chronic Liver Disease (CLD) cohort
Patients with chronic liver disease, including liver cirrhosis and chronic hepatitis, without evidence of hepatocellular carcinoma.
Blood or other biospecimens will be collected for multi-omics profiling.
干预措施: Rt-qPCR (Diagnostic Test)
Healthy Controls
Healthy individuals without known liver disease or malignancy who will provide blood or other biospecimens as normal controls for biomarker evaluation.
干预措施: Rt-qPCR (Diagnostic Test)
结局指标
主要结局
Sensitivity
时间窗: Through study completion, an average of 1 year
True Positive Rate: the probability of a positive test result, conditioned on the individual truly being positive
次要结局
- Specificity(Through study completion, an average of 1 year)
- Proportion of correct predictions (true positives and true negatives) among the total number of cases (i.e.,accuracy)(Through study completion, an average of 1 year)