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

NCT07260370 | Recruiting

• 1 other identifier: 201800596B0
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

microRNA; Circulating Tumor Cells; Immunotherapy

Keywords

Cancer; Plasma; Immunotherapy; microRNA; Circulating Tumor Cell

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• microRNAs sequence

  baseline,pre-iprocedure

• microRNAs sequence

  3 month, during procedure

• microRNAs sequence

  6 month

Other Outcomes (2)

• Treatment response

  3 month, during procedure

• Treatment response

  6 month

Study Arms (1)

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.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• Aged \< 20 years.
• Refuse to join the study

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Linkou Chang Gung Memorial Hospital

Taoyuan, Taiwan

RECRUITING

MeSH Terms

Conditions

Neoplastic Cells, Circulating; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chia-Hsun Hsieh, PhD

  Division of Oncology, Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chia-Hsun Hsieh, PhD

CONTACT

0975366137; wisdom5000@gmail.com

PO-JUNG SU, PhD

CONTACT

0975366135; pjsu@cgmh.org.tw

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Attending Physicians

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 3, 2025
• Study Start: May 23, 2018
• Primary Completion: December 27, 2025
• Study Completion: April 30, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-11

Locations

TW (1)