The Difference of microRNA Signature(S) and Circulating Tumor Cells in Blood Among Cancer Patients Before and Afte Immunotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- counting of Circulating Tumor Cells
研究概览
简要总结
Among the currently important biomarkers, circulating tumor cells and microRNA (miRNA) have received significant attention. The latter, also translated as micro-ribonucleic acid, is a widely present ribonucleic acid (RNA) molecule in eukaryotes, approximately 21 to 23 nucleotides in length, which regulates the expression of other genes. miRNAs originate from RNAs that are transcribed from DNA but cannot be further translated into proteins (classified as non-coding RNA). miRNAs bind to target messenger RNA (mRNA), thereby inhibiting post-transcriptional gene expression, and play important roles in regulating gene expression, the cell cycle, and the timing of biological development.The project will recruit 300 subjects who have been diagnosed with cancer by a physician and for whom the decision has been made to use immunotherapy. Blood samples will be collected before and after treatment (past pathological diagnostic tissues may also be reviewed as required for the study). The study will analyze the differences in the quantity of free microRNAs, the number of circulating tumor cells, and the differences in surface antigen expression in the subjects' blood, as well as the specific surface antigen expression status in the cancer tissues, and perform statistical analysis.
详细描述
Among the currently important biomarkers, circulating tumor cells and microRNA (miRNA) have received significant attention. The latter, also translated as micro-ribonucleic acid, is a widely present ribonucleic acid (RNA) molecule in eukaryotes, approximately 21 to 23 nucleotides in length, which regulates the expression of other genes. miRNAs originate from RNAs that are transcribed from DNA but cannot be further translated into proteins (classified as non-coding RNA). miRNAs bind to target messenger RNA (mRNA), thereby inhibiting post-transcriptional gene expression, and play important roles in regulating gene expression, the cell cycle, and the timing of biological development.The project will recruit 300 subjects who have been diagnosed with cancer by a physician and for whom the decision has been made to use immunotherapy. Blood samples will be collected before and after treatment (past pathological diagnostic tissues may also be reviewed as required for the study). The study will analyze the differences in the quantity of free microRNAs, the number of circulating tumor cells, and the differences in surface antigen expression in the subjects' blood, as well as the specific surface antigen expression status in the cancer tissues, and perform statistical analysis.
For the trial, only two tubes of 10cc peripheral blood will be drawn (20cc total, using large purple-top collection tubes). Subjects will participate in a maximum of three blood draws for this trial (before immunotherapy, after immunotherapy, and during follow-up imaging).
Through drawing the patient's blood, extracting plasma, purifying microRNAs, and converting them into complementary deoxyribonucleic acid (cDNA)-in conjunction with cancer diagnostic materials (collected during past diagnoses, no new samples needed)-the miRSCanPanelChip™ platform will be utilized to screen and statistically analyze the quantity of free microRNAs in the plasma. Finally, the correlation between the RNA quantities, the number of circulating tumor cells, and the clinical treatment response will be analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged above 20 years.
- •A patient diagnosed with cancer with immunotherapy
- •Competent to give informed consent and agree to join the study.
排除标准
- •Aged < 20 years.
- •Refuse to join the study
结局指标
主要结局
counting of Circulating Tumor Cells
时间窗: 6 month
The study will do the counting of circulating tumor cells in the participants with immunotherapy.
次要结局
- microRNAs sequence(6 month)
研究者
Jason Chia-Hsun Hsieh
Professor Attending Physicians
Chang Gung Memorial Hospital
