Detected the Valuable Characteristic Changes Both in Circulating Cell-free DNA and Primary Tumor in the Patients With Hepatocelluar Carcinoma.
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- To collect the DNA samples from the plasma, blood cells and solid tumor tissues in the patients with HCC.
研究概览
简要总结
Circulating free cell DNA (cfDNA) is extracellular fragmentation of nucleic acids that occurs both in plasma and serum. This kind of DNA which derived from the apoptotic/necrotic cells or the lysis of circulating tumor cells (CTCs) can be detectedin the patients with a variety of diseases. Emerging evidence suggests that cfDNA from patients exhibits characteristicchanges of tumors, suchas mutations, insertions/deletions, methylations,microsatellite aberrations, and copy number variations, etc. All of these reveal a visible difference between the benign conditions, and thus may be useful in the diagnosis of cancer, identification of targeted therapy, monitor responses to treatments, and early detection of relapse. The purpose for this study is to explore these characteristic changes in the patients withhepatocellular carcinoma (HCC) and expect to guide targeted therapy and identify non-invasive biomarkers of cancer diagnosis and prognosis which can be easily isolated from the circulation.
详细描述
In cancer, cfDNA can be detected a higher concentration in the circulation because of the necrosis of neoplasm cells with the rapid enlargement and relatively shortage of blood supply. So, identifying tumor-specific genetic and epigenetic changes in cfDNA on this status, such as gene mutations, deletions, methylation alterations and microsatellite alterations, may be more specific for us to diagnose the neoplasms in early phase. This phenomenon also appears in the patients with hepatocellular carcinoma (HCC). Studies have shown that cfDNA level is associated with intrahepatic and extrahepatic metastasis in HCC patients and examined some cfDNAcharacteristic changes, such as p161NK4A, RTL, RASSF1A, LINE-1 and GSTP1. Thus is useful for us to explore the specific cfDNA in HCC. For a high sensitivity and specificity detection, we will use technologiesdeveloped at Stanford Genome Technology Centerto find more characteristic gene mutations, methylation alterations or other changes (3). In this study, we willinvestigate thesecharacteristic changesin cfDNA and primary tumor lesions.
Study arrangement:
Collect the DNA samples from the plasma, blood cells and solid tumor tissues in the patients with HCC.
Detect the DNA sequence from the samples of plasma, blood cells and solid tumor tissues.
Identify cancer specific variations in cfDNA and primary tumor lesions. Date analysis and investigate these characteristic changes. Evaluate the application in early diagnosis, treatment monitoring and prognosis for HCC.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age≥18years and ≤80 years; Histologically and cytologically proven Hepatocellular carcinoma Child-Pugh：child A-B Adequate hematological, renal, cardiac and pulmonary functions Tumor in any segment of liver
排除标准
- •Uncontrolled systemic disease Reject the surgical treatment Metastatic carcinoma Child-Pugh：child C
结局指标
主要结局
To collect the DNA samples from the plasma, blood cells and solid tumor tissues in the patients with HCC.
时间窗: three months
In the first three months in this study, we will collect 5 samples from the plasma, blood cells and primary tumor lesions in the patients with HCC in three stages including preoperative, postoperative (2 weeks) and postoperative (1 month). It is better for us to find the characteristic changes when we make a detailed comparison between the samples in these period. These samples include 5ml plasma, 2ml blood cells without plasma and at least 10mg solid tumor tissues.
次要结局
- Investigate the value characteristic changes from the DNA samples.(three months)
- Evaluate the sensitivity and specificity with these changes in HCC(four months)
- Date analysis(two months)
- Early diagnosis, treatment monitoring and prognosis evaluation.(twelve months)