Microfluidic blood test using tumor cell clusters and NK cell signals to predict outcomes in recurrent or metastatic head and neck squamous cell cancer
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
This project will test whether a blood-based microfluidic test that looks at circulating tumor cell clusters and NK cell IFN-γ signals can help predict outcomes for people with recurrent or metastatic head and neck squamous cell carcinoma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Zhubei, HsinChu County) |
| Trial ID | NCT06678724 on ClinicalTrials.gov |
What this trial studies
This observational study collects blood from patients with recurrent or metastatic head and neck squamous cell carcinoma who are receiving standard care and analyzes circulating tumor cells (CTCs), circulating tumor microemboli (CTM), and immune cell composition within CTM using a DS-SACA microfluidic chip. Investigators will measure NK cell IFN-γ expression and other immune markers within CTM and correlate those findings with clinical outcomes and treatment responses. The study focuses on a Taiwanese patient population to capture regional disease patterns such as betel-nut–associated cancers. No investigational treatments are given; samples are taken alongside routine care and medical record data are used for outcome correlations.
Who should consider this trial
Good fit: Adults (≥20 years) with pathologically confirmed recurrent or metastatic squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx, ECOG performance status 0–2, at least one measurable lesion per RECIST 1.1, able to provide informed consent and blood samples are ideal candidates.
Not a fit: Patients without measurable disease, those unable to provide blood samples or consent, and those with non-squamous head and neck cancers or poor performance status (ECOG >2) are unlikely to benefit from the test results.
Why it matters
Potential benefit: If successful, this approach could offer a minimally invasive blood test to better predict prognosis and help guide treatment choices for patients with recurrent or metastatic head and neck squamous cell carcinoma.
How similar studies have performed: Previous studies have shown that circulating tumor cells and clusters can have prognostic value in several cancers, but combining CTM analysis with NK cell IFN-γ profiling on a DS-SACA microfluidic platform is relatively novel and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: must fulfill with all the items below * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-2. * \>=20 years old. * had pathologically confirmed squamous cell carcinoma of the oropharynx, oral cavity, hypopharynx, or larynx that was recurrent or metastatic and not curable by local therapy. * had at least one tumor lesion measurable per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 * Medical records during treatment are available. Exclusion Criteria: * Medical records during treatment unavailable * Could not cooperate with blood sampling * Without informed consent
Where this trial is running
Zhubei, HsinChu County
- National Taiwan University HsinChu Branch — Zhubei, HsinChu County, Taiwan (Recruiting)
Study contacts
- Study coordinator: Hsu Wu, M.D.
- Email: G04187@hch.gov.tw
- Phone: +886-3-5326151
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.