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The Difference of microRNA and Circulating Tumor Cells in Blood Among Cancer Patients With Immunotherapy

The Difference of microRNA Signature(S) and Circulating Tumor Cells in Blood Among Cancer Patients Before and Afte Immunotherapy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07260370
Enrollment
300
Registered
2025-12-03
Start date
2018-05-23
Completion date
2026-04-30
Last updated
2025-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Circulating Tumor Cells, Immunotherapy, microRNA

Keywords

Cancer, Plasma, Immunotherapy, microRNA, Circulating Tumor Cell

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum

Inclusion criteria

1. Aged above 20 years. 2. A patient diagnosed with cancer with immunotherapy 3. Competent to give informed consent and agree to join the study.

Exclusion criteria

1. Aged \< 20 years. 2. Refuse to join the study

Design outcomes

Primary

MeasureTime frameDescription
counting of Circulating Tumor Cellsbaseline,pre-iprocedureThe study will do the counting of circulating tumor cells in the participants with immunotherapy.

Secondary

MeasureTime frameDescription
microRNAs sequencebaseline,pre-iprocedureThe study will analyze the differences in the quantity of free microRNAs

Other

MeasureTime frameDescription
Treatment response3 month, during procedureRecord the response after immuntherapy

Countries

Taiwan

Contacts

Primary ContactChia-Hsun Hsieh, PhD
wisdom5000@gmail.com0975366137
Backup ContactPO-JUNG SU, PhD
pjsu@cgmh.org.tw0975366135

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026