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

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.

Study Overview

• Status: Recruiting
• Conditions: Immunotherapy; microRNA; Circulating Tumor Cells

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Chia-Hsun Hsieh, PhD; Phone Number: 0975366137; Email: wisdom5000@gmail.com
• Study Contact Backup: Name: PO-JUNG SU, PhD; Phone Number: 0975366135; Email: pjsu@cgmh.org.tw

Study Locations

• Taiwan
  • Taoyuan, Taiwan
    • Recruiting
    • Linkou Chang Gung Memorial Hospital
    • Contact: Chia-Hsun Hsieh, PhD; Phone Number: 0975366137; Email: wisdom5000@cgmh.org.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	3 month, during procedure
microRNAs sequence	The study will analyze the differences in the quantity of free microRNAs	6 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment response	Record the response after immuntherapy	3 month, during procedure
Treatment response	Record the response after immuntherapy	6 month

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Chia-Hsun Hsieh, PhD, Division of Oncology, Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2018
• Primary Completion (Estimated): December 27, 2025
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: November 21, 2025
• First Submitted That Met QC Criteria: November 21, 2025
• First Posted (Estimated): December 3, 2025

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Cancer; Immunotherapy; microRNA; Plasma; Circulating Tumor Cell
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplastic Processes; Neoplasm Metastasis; Pathological Conditions, Signs and Symptoms; Neoplasms; Neoplastic Cells, Circulating
• Other Study ID Numbers: 201800596B0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No