Actively Recruiting
Establishment of a Microfluidic Liquid Biopsy Platform to Study NK Cell IFN-γ and Circulating Tumor Emboli in Recurrent or Metastatic Head and Neck Cancer Prognosis
Led by National Taiwan University Hospital · Updated on 2026-02-24
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
N
National Taiwan University Hospital
Lead Sponsor
N
National Taiwan University Hospital Hsin-Chu Branch
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the role of circulating tumor emboli (CTM) and natural killer (NK) cell activity in patients with recurrent or metastatic head and neck squamous cell carcinoma. This observational study aims to assess how CTM and the immune cells within them relate to patient outcomes and treatment effectiveness, focusing on a Taiwanese population with distinct risk factors like betel nut use. The study seeks to improve understanding of tumor microenvironment changes and their impact on prognosis under various treatments. Participants will receive their usual care from their primary doctors while researchers collect blood samples to analyze circulating tumor cells, CTM clusters, and NK cell composition using a microfluidic liquid biopsy platform called the DS-SACA chip. The study does not involve administering treatments but observes patients receiving different therapies. The goal is to correlate these biological markers with clinical data to help predict progression and survival. During the study, participants will provide blood samples for detailed analyses of tumor and immune cells. Researchers will monitor progression-free survival and overall survival for up to 60 months to evaluate correlations with the biomarkers. Medical records and clinical outcomes will be reviewed to support these assessments. The study includes adults aged 20 years and older with measurable recurrent or metastatic tumors who can provide informed consent and cooperate with blood sampling procedures.
CONDITIONS
Brief Title
Establishment of a Microfluidic Based Liquid Biopsy Platform for Recurrent/Metastatic Head and Neck Cancers Prognostication Using NK Cell IFN-γ Expression and CTM Correlation With DS-SACA Chip
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-2
- 20 years old or older
- Pathologically confirmed recurrent or metastatic squamous cell carcinoma of the oropharynx, oral cavity, hypopharynx, or larynx not curable by local therapy
- At least one measurable tumor lesion per RECIST version 1.1
- Medical records during treatment are available
You will not qualify if you...
- Medical records during treatment unavailable
- Unable to cooperate with blood sampling
- Without informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 60 months
Participants undergo blood sampling and clinical assessments to evaluate circulating tumor cells and tumor emboli for prognosis.
Periodic blood sampling visits during follow-up
Duration - Up to 60 months
Participants are monitored for progression-free and overall survival outcomes up to 60 months after enrollment.
Follow-up visits as scheduled for up to 60 months
Trial Site Locations
Total: 1 location
1
National Taiwan University HsinChu Branch
Zhubei, HsinChu County, Taiwan, 302058
Actively Recruiting
Research Team
H
Hsu Wu, M.D.
W
Wei-Chen Lu, M.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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