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

ConditionsHead and Neck Cancers- Squamous Cell Head and Neck Cancer Metastatic Recurrent Head and Neck Squamous Cell Carcinoma

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age20+

SponsorNational Taiwan University Hospital

About this trial

The goal of this observational study is to learn about the prognostic value of circulation tumor emboli (CTM) in recurrent/metastatic head and neck cancer patients and also the changes of tumor microenvironment by different treatment modalities and drugs. The main questions it aims to answer are:

1. Investigators plan to correlate circulating tumor cells (CTC), circulating tumor emboli (CTM), and the composition of NK cells in CTM with clinical outcomes and establish their association with patient prognosis. 2. Investigators plan to understand the composition of NK cells and the immune cell components within CTM, and correlate these findings with treatment efficacy.

Patients with recurrent/metastatic head and neck cancer will be included after informed consent and investigators will collect blood samples for analysis from them under the treatment provided by their primary care physicians.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Medical records during treatment unavailable

Could not cooperate with blood sampling

Without informed consent

Trial population

Recurrent/Metastatic squamous cell carcinoma of the head and neck

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

30 Participants

are grouped into 1 trial group

Group A: Recurrent/Metastatic squamous cell carcinoma of the head and neck

Trial outcomes

Primary outcomes

Progression-free survival (PFS)

The time from diagnosis as non-curable disease to clinically (physical examination or radiographically) confirmed disease progression or death from any cause, whichever came first.

Time frame

From enrollment to until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

Secondary outcomes

Overall survival (OS)

The time from diagnosis as non-curable disease to death from any cause

Time frame

From date of enrollment until the date of death from any cause, whichever came first, assessed up to 60 months

Sponsors and contacts

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National Taiwan University Hospital

Lead sponsor

National Taiwan University Hospital Hsin-Chu Branch

Collaborator

National Taiwan University Hospital, Yun-Lin Branch