跳至主要内容
临床试验/NCT06678724
NCT06678724招募中不适用

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

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Progression-free survival (PFS)

研究概览

简要总结

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.

详细描述

Head and neck cancer, including oral, oropharyngeal and hypopharyngeal cancer, is the third most common type of cancer and the fourth leading cause of death of cancer among male patients in Taiwan according to the 2021 cancer registry. Despite surgery and adjuvant concurrent chemoradiotherapy (CCRT) for locally advanced head and neck cancer, there still were 20 to 30 % of patients who had recurrent disease within 2 years. For patients who were not suitable to receive surgery, the progression free survival was even worse, especially for those with HPV negative cancer In Taiwan, there is a special category of head and neck cancer which is associated with betel nut use and the molecular basis of this type of cancer is different. This is the most important reason why studies should be done in Taiwanese population.

In recent years, numbers of studies have confirmed that circulating tumor cells (CTCs) play a key role in the process of tumor metastasis and recurrence. The collection and analysis of CTCs is expected to provide patients with important information that was not easily available in the past and assist in planning of follow-up treatments strategy. However, CTCs research still faces many challenges, including: (1) The current clinical CTCs detection platform cannot tell whether the isolated cells contain the CTCs cluster or CTM from patient's liquid biopsy; (2) Lack of analytical technology to identify metastasis risk from the isolated CTCs and (3) how to analyze the immune microenvironment in CTM and apply it to formulate therapeutic strategy of the follow-up treatment.

As mentioned above, there are a group of patients who would experience recurrence locally or distant metastases within a short period of time after curative treatment. First, investigators want to establish a platform to predict recurrence and prognosis. By using the number of circulating tumor cells (CTCs), circulating tumor emboli (CTM) and INF-γ level incorporated with clinical factors to correlate with patient prognosis. Second, investigators want to evaluate the component of NK cells in CTM, and elucidate their correlation with different risk factors, including HPV status, smoking and betel nut use, treatment modalities, treatment drugs and patient prognosis.

This research will elucidate not only prognostic value of CTM, but also the changes of tumor microenvironment by different treatment modalities and drugs.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • must fulfill with all the items below
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-
  • >=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.

排除标准

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

研究组 & 干预措施

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.

结局指标

主要结局

Progression-free survival (PFS)

时间窗: 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

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.

次要结局

  • Overall survival (OS)(From date of enrollment until the date of death from any cause, whichever came first, assessed up to 60 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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