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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.
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 miRSCanPanelChipâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cancer for microRNA testing | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| counting of Circulating Tumor Cells | The study will do the counting of circulating tumor cells in the participants with immunotherapy. | baseline,pre-iprocedure |
| counting of Circulating Tumor Cells | The study will do the counting of circulating tumor cells in the participants with immunotherapy. | 3 month, during procedure |
| counting of Circulating Tumor Cells | The study will do the counting of circulating tumor cells in the participants with immunotherapy. | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| microRNAs sequence | The study will analyze the differences in the quantity of free microRNAs | baseline,pre-iprocedure |
| microRNAs sequence | The study will analyze the differences in the quantity of free microRNAs |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment response | Record the response after immuntherapy | 3 month, during procedure |
| Treatment response | Record the response after immuntherapy |
Inclusion Criteria:
Exclusion Criteria:
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The most crucial factor in preventing death for cancer patients is early diagnosis and the detection of recurrence.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. 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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chia-Hsun Hsieh, PhD | Contact | 0975366137 | wisdom5000@gmail.com | |
| PO-JUNG SU, PhD | Contact | 0975366135 | pjsu@cgmh.org.tw |
| Name | Affiliation | Role |
|---|---|---|
| Chia-Hsun Hsieh, PhD | Division of Oncology, Chang Gung Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linkou Chang Gung Memorial Hospital | Recruiting | Taoyuan City | Taiwan |
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| ID | Term |
|---|---|
| D009360 | Neoplastic Cells, Circulating |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 3 month, during procedure |
| microRNAs sequence | The study will analyze the differences in the quantity of free microRNAs | 6 month |
| 6 month |