Detection of Plasma DNA Methylation in Peripheral Blood From Patients With Hepatocellular Carcinoma (ATHENA)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Multi-target hepatocellular carcinoma panel (MHP) score
研究概览
简要总结
This study explores the potential values of a new blood test approach to detect measurable residual disease or early coming back of cancer (recurrence)/cancer growing, spreading, or getting worse (progression) in patients with liver cancer that can be removed by surgery (resectable). The development of novel cancer biomarkers for liver cancer may help in clinical decision making and lead to improvements in patient outcomes by facilitating prediction of the response to specific treatments, improved monitoring of patients on treatment, and better prognostication of patient outcomes, thus improving stratification for clinical trials.
详细描述
PRIMARY OBJECTIVES:
I. To isolate plasma deoxyribonucleic acid (DNA) methylation panel from the peripheral blood of treated patients with hepatocellular carcinoma that will correlate with disease progression or measurable residual disease.
II. To correlate the mutations/ DNA methylation in peripheral blood with those identified in parallel tumor samples from the same patients with hepatocellular (HCC).
OUTLINE:
Patients undergo collection of blood samples at 4-6 weeks prior to surgery/ablation and at 12 weeks, 6, 12, 18 and 24 months after surgery/ablation. Patients' previously collected tissue samples are analyzed. Patients' medical records are also reviewed at baseline, 4-6 weeks prior to surgery/ablation, 12 weeks, 6, 12, 18 and 24 months after surgery/ablation, and then every 6 months for 3 years.
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
- •Patient has planned resection or ablation of suspected hepatocellular carcinoma
- •Patient is classified as resectable T1/T2 hepatocellular carcinoma (HCC) (solitary tumors less than or equal to 2 cm OR solitary tumors without vascular invasion > 2cm or solitary tumor with vascular invasion > 2cm, or multiple tumors, none > 5cm) OR BCLC stage A (Single lesion of ANY size or 3 nodules or less with each being 3cm or less)
排除标准
- •Patient is younger than 18 years of age
- •Females who are pregnant or attempt to become pregnant
- •Patient with significant anemia (hemoglobin [Hb] < 7g/dL)
- •Patient has known cancer outside of the liver 5 years prior to current blood collection (not including basal cell or squamous cell skin cancers)
- •Patient has had a biopsy to the target organ and/or lesion within 3 days before blood collection
- •Patient has had an intervention to completely remove current target pathology
- •Target pathology is a recurrence of previously treated HCC
- •Patient has had prior resection or ablation for target lesion
- •Patient has had prior or active chemotherapy or radiation for target lesion
研究组 & 干预措施
Observational (biospecimen collection, medical record review)
Patients undergo collection of blood samples at 4-6 weeks prior to surgery/ablation and at 12 weeks, 6, 12, 18 and 24 months after surgery/ablation. Patients' previously collected tissue samples are analyzed. Patients' medical records are also reviewed at baseline, 4-6 weeks prior to surgery/ablation, 12 weeks, 6, 12, 18 and 24 months after surgery/ablation, and then every 6 months for 3 years.
干预措施: Biospecimen Collection (Procedure)
Observational (biospecimen collection, medical record review)
Patients undergo collection of blood samples at 4-6 weeks prior to surgery/ablation and at 12 weeks, 6, 12, 18 and 24 months after surgery/ablation. Patients' previously collected tissue samples are analyzed. Patients' medical records are also reviewed at baseline, 4-6 weeks prior to surgery/ablation, 12 weeks, 6, 12, 18 and 24 months after surgery/ablation, and then every 6 months for 3 years.
干预措施: Electronic Health Record Review (Other)
结局指标
主要结局
Multi-target hepatocellular carcinoma panel (MHP) score
时间窗: Up to 1 year
Descriptive statistics will be used. The association between the MHP score and patient and tumor characteristics with state occupancy probability will be examined using the Cox proportional hazards model. Serial measurements of the MHP score obtained on subsequent visits will be accounted for within the Cox model by treating them as time varying covariate. To assess the relative importance of the MHP score to individual alpha fetoprotein (AFP) levels for the prediction of hepatocellular carcinoma recurrence, the area under the receiver operator characteristic curve will be compared between the MHP score model and an AFP only model.
Multi-target hepatocellular carcinoma blood test (mt-HBT) score
时间窗: Up to 3 years
Association between mt-HBT score and patient and tumor characteristics with state occupancy probability will be examined using the Cox proportional hazards model. Serial measurements of the mt-HBT score obtained on subsequent visits will be accounted for within the Cox model by treating them as time varying covariate. To assess the relative importance of the mt-HBT score to individual alpha fetoprotein (AFP) levels for the prediction of hepatocellular carcinoma (HCC) recurrence, the area under the receiver operator characteristic curve (AUC) will be compared between the mt-HBT score model and an AFP only model.
Recurrence-free Survival
时间窗: Up to 3 years
Assessed as the time from study enrollment until recurrence of hepatocellular carcinoma (HCC).
Overall Survival
时间窗: Up to 3 years
Assessed as the time from study enrollment until death due to any cause. Will be censored for those lost to follow up or completion of study without events.
次要结局
未报告次要终点