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NCT Number: NCT07260370

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

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Linkou Chang Gung Memorial Hospital

Taoyuan City, Taiwan

Location status: Recruiting

Location contact

Chia-Hsun Hsieh, PhD

CONTACT

[email protected]

0975366137

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. counting of Circulating Tumor Cells

    Time frame: baseline,pre-iprocedure

    The study will do the counting of circulating tumor cells in the participants with immunotherapy.

  2. counting of Circulating Tumor Cells

    Time frame: 3 month, during procedure

    The study will do the counting of circulating tumor cells in the participants with immunotherapy.

  3. counting of Circulating Tumor Cells

    Time frame: 6 month

    The study will do the counting of circulating tumor cells in the participants with immunotherapy.

Secondary outcomes

  1. microRNAs sequence

    Time frame: baseline,pre-iprocedure

    The study will analyze the differences in the quantity of free microRNAs

  2. microRNAs sequence

    Time frame: 3 month, during procedure

    The study will analyze the differences in the quantity of free microRNAs

  3. microRNAs sequence

    Time frame: 6 month

    The study will analyze the differences in the quantity of free microRNAs

Other outcomes

  1. Treatment response

    Time frame: 3 month, during procedure

    Record the response after immuntherapy

  2. Treatment response

    Time frame: 6 month

    Record the response after immuntherapy

Study contacts

Contact information is provided by the study sponsor or research team.

Chia-Hsun Hsieh, PhD

CONTACT

[email protected]

0975366137

PO-JUNG SU, PhD

CONTACT

[email protected]

0975366135

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2025
Study completion
2026
First posted
Dec 3, 2025
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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