The Detection of Small Early Liver Cancer With Natural History Follow up
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Biomarkers associated with small HCC (Early detection [EDx] biomarkers)
研究概览
简要总结
The SELINA study will recruit 200 patients with cirrhosis and small HCC and 50 patients with HCC but without cirrhosis (most of whom are expected to have FLD). Blood, urine and liver tissue samples (where available) will be collected for laboratory analysis. In a subgroup of patients (N=80, around 64 patients with HCC with liver cirrhosis and around 16 patients with HCC without liver cirrhosis), additional magnetic resonance liver imaging will be performed. The findings of the SELINA study aim to identify biomarkers that can be used to detect liver cancer at the earliest possible time, something we expect will increase the survival rate of HCC.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is willing and able to give informed consent for participation in the study.
- •Male or Female aged 18 years or above.
- •Diagnosed with small HCC (Barcelona Clinic Liver Cancer Staging Criteria (BCLC) stage 0/A; 1-3 nodules <3cm, preserved liver function, performance status 0) with liver cirrhosis from any aetiology
- •Diagnosed with small HCC (as above) and without cirrhosis
- •Diagnosis of small HCC shown or confirmed within 3 months of study Visit 1
- •Patients with a diagnosis of HCC that was fully ablated or resected more than 6 months ago and now presenting with a new diagnosis of HCC in a different site in the liver may be included in the study
- •Histological confirmation is required to establish the diagnosis of HCC in patients without cirrhosis (imaging alone is not considered sufficient to establish the diagnosis of HCC).
排除标准
- •Patients judged by the investigator to be unsuitable for inclusion in the study (e.g. where the investigator feels that the participant will not be able to comply with the study procedures)
- •HCC with liver cirrhosis at BCLC stage B/C
- •Patients who have had a previous liver transplant (note, it is permitted to enrol patients on the liver transplant waiting list if they fulfil all inclusion/exclusion criteria)
- •Participants of the Pearl study
- •Patients who have had a previous diagnosis of HCC followed by therapy, and now have a recurrence at the same site in the liver
- •Patients who have received HCC specific therapy 3 months prior to study visit 1 (including resection, ablation [microwave/radiofrequency]), transarterial chemoembolization [TACE], select internal radiation therapy [SIRT] or stereotactic body radiation therapy [SBRT] 3, chemotherapy, immune modulators and other experimental therapies).
- •Exclusion Criteria for Imaging Subgroup
- •Any contra-indication to Magnetic Resonance Imaging (MRI) (e.g. claustrophobia, metal implants/fragments, implants, pregnancy, other conditions the scanner operator deems unsafe for MR scanning).
结局指标
主要结局
Biomarkers associated with small HCC (Early detection [EDx] biomarkers)
时间窗: Throughout study to completion; up to 5 years
Classification performance metrics of EDx biomarkers, in cirrhosis patients with small HCC compared to non-HCC cirrhosis patients
次要结局
- Whether combinations of EDx tests improve the diagnostic and prognostic performance(Throughout study to completion; up to 5 years)
- Prognostic ability of Early Detection (EDx) bio-markers(Throughout study to completion; up to 5 years)
- Proportion of patients with HCC events according to time since treatment with curative intent.(Throughout study to completion; up to 5 years)