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

NCT06678724 | Recruiting

• 1 other identifier: 202409056RINC
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 2.Investigators plan to understand the composition of NK cells and the immune cell components within CTM, and correlate these findings with treatment efficacy.

Conditions

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

Keywords

head and neck cancer; circulating tumor cell; CTC; circulating tumor emboli; CTM; NK cell; nature killer cell; prognosis; INF-gamma

Outcome Measures

Primary Outcomes (1)

• 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.

  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 (1)

• Overall survival (OS)

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

Study Arms (1)

Recurrent/Metastatic squamous cell carcinoma of the head and neck

Patient inclusion criteria, must fulfill with all the items below 1\. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-2.\>=20 years old. 3\. 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. 4\. had at least one tumor lesion measurable per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 5. Medical records during treatment are available.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Recurrent/Metastatic squamous cell carcinoma of the head and neck

You may qualify if:

• 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.

You may not qualify if:

• Medical records during treatment unavailable
• Could not cooperate with blood sampling
• Without informed consent

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Taiwan University Hospital, Yun-Lin Branch: collaborator
• National Taiwan University Hospital Hsin-Chu Branch: collaborator

Study Sites (1)

National Taiwan University HsinChu Branch

Zhubei, HsinChu County, 302058, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms; Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hsu Wu, M.D.

CONTACT

+886-3-5326151; G04187@hch.gov.tw

Wei-Chen Lu, M.D.

CONTACT

+886-5-5323911

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 7, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: starting 6 months after publication

Locations

TW (1)