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

NCT ID: NCT07260370

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-05-23
• Study Completion Date: 2026-04-30

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.

Conditions

microRNA; Circulating Tumor Cells; Immunotherapy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jason Chia-Hsun Hsieh

Professor Attending Physicians

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chia-Hsun Hsieh, PhD

Role: PRINCIPAL_INVESTIGATOR

Division of Oncology, Chang Gung Memorial Hospital

Locations

Linkou Chang Gung Memorial Hospital

Taoyuan, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Chia-Hsun Hsieh, PhD

Role: CONTACT

wisdom5000@gmail.com

0975366137

PO-JUNG SU, PhD

Role: CONTACT

pjsu@cgmh.org.tw

0975366135

Facility Contacts

Chia-Hsun Hsieh, PhD

Role: primary

wisdom5000@cgmh.org.tw

0975366137

Other Identifiers

201800596B0

Identifier Type: -

Identifier Source: org_study_id