Circulating Tumor Cells and Tumor DNA in HCC and NET - Patient-specific Biomarkers for Clinical Decision Support and Tailored Relapse Diagnostics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 167
- 试验地点
- 1
- 主要终点
- Concordance between specific DNA mutations found in patient biopsies and plasma circulating tumor DNA
研究概览
简要总结
Background Treatment and control of cancer is associated with high costs, to patients in the form of side effects and discomfort during investigations, to society in the form of expensive drugs and studies.
Circulating tumor cells (CTC) has received great attention as a cancer biomarker in trying to estimate future course in patients with breast cancer, colon cancer and prostate cancer. CTC is believed to be a crucial step in cancer spreading to the bloodstream and giving rise to metastases. Detection of circulating tumor DNA (ctDNA) specifically adds specificity to the analysis of the CTC.
The investigators would like to with molecular biological methods predict which patients requires special monitoring and individualized therapy and explore these tests as clinical decision support.
Purpose and method
In a blood sample from patients with neuro-endocrine tumor (NET) and hepatocellular carcinoma (HCC), the investigators will by cell separation, flow cytometry and DNA sequencing and digital polymerase chain reaction (PCR):
- Identify and isolate the CTC and investigate these for tumor-specific mutations.
- Quantify ctDNA and analyze this for specific mutations, which in the past has been found frequent in NET and HCC.
- Compare findings of mutations on CTC and ctDNA with mutations in tissue biopsies.
The results are compared with the clinical data on disease course, including the effect of treatment and survival.
Subjects 40 Patients with small intestinal/unknown primary NET before treatment with somatostatin analogues 30 patients with pancreatic NET before treatment with Everolimus 30 patients with presumed radically treated HCC 30 patients with HCC in treatment with Sorafenib A blood sample will be taken prior to the start of treatment, after 1 month after start of treatment and thereafter every 3.-6. month for up to two years.
Perspectives In several cancer types molecular diagnostics have had significant influence in treatment and control strategy. The goal is in future to be able to take advantage of a so-called "liquid biopsy" as clinical decision support. The study will bring new knowledge to this growing field of research.
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
- •one of the above mentioned diseases
- •planed surgery, RFA, Somatostatin Analogue, Sorafenib or Everolimus treatment
- •signed informed consent
排除标准
- •age below 18, concomitant invasive cancer (not skin cancer) and planed emigration of Denmark.
研究组 & 干预措施
NET ssta
Small intestinal or unknown primary NET patients referred for treatment with somatostatin analogues, eg. lanreotide and octreotide
干预措施: Lanreotide (Drug)
HCC sorafenib
HCC patients referred for Sorafenib treatment
干预措施: Sorafenib (Drug)
HCC curative treatment
HCC patient undergoing potential curative treatment, eg. radiofrequency ablation (RFA) or resection
干预措施: Radiofrequency ablation (RFA) or surgery (Procedure)
NET everolimus
Pancreatic NET patients referred for Everolimus treatment
干预措施: Everolimus (Drug)
结局指标
主要结局
Concordance between specific DNA mutations found in patient biopsies and plasma circulating tumor DNA
时间窗: 2 months
Methods: digital droplet PCR and targeted sequencing of blood samples and biopsies
次要结局
- Correlations between mutations found in circulating tumor DNA and amount of circulating tumor cells and treatment response according to RECIST criteria(up to 5 years)
- Correlations between mutations fund in circulating DNA and circulating tumor cells(3 years)
- Flow cytometry for detection and quantification of CTC in peripheral blood (absolute and relative counts)(3 years)
- Correlations between mutations found in circulating tumor DNA and amount of circulating tumor cells and survival(up to 5 years)