Head and Neck Cancers- Squamous CellNCT06678724
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
An observational study of Head and Neck Cancers- Squamous Cell and Head and Neck Cancer Metastatic, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Head and Neck Cancers- Squamous Cell, Head and Neck Cancer Metastatic, Recurrent Head and Neck Squamous Cell Carcinoma
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2025to 31 Dec 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Recurrent/Metastatic squamous cell carcinoma of the head and neck
Who may be able to join
- 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.
Who cannot join
- Medical records during treatment unavailable
- Could not cooperate with blood sampling
- Without informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Wei-Chen Lu, M.D. contact
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University HsinChu Branch
Zhubei, HsinChu County, 302058
Hsu Wu, M.D., +886-3-5326151 ext. 4502, G04187@hch.gov.tw
Wei-Chen Lu, M.D., +886-5-5323911 ext. 574602
About this study
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:
- 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.
- 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.
Read the detailed description
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.
- 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
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
The time from diagnosis as non-curable disease to death from any cause
Measured: From date of enrollment until the date of death from any cause, whichever came first, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start1 Jan 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Cancers- Squamous CellStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital Hsin-Chu Branch, National Taiwan University Hospital, Yun-Lin Branch
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06678724
- Sponsor's protocol ID
- 202409056RINC
- Status last verified
- Feb 2026
- First submitted
- 31 Oct 2024
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06678724
- Acronym / sponsor ID
- 202409056RINC
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital Hsin-Chu Branch, National Taiwan University Hospital, Yun-Lin Branch
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Recurrent/Metastatic squamous cell carcinoma of the head and neck
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Medical records during treatment unavailable
- Could not cooperate with blood sampling
- Without informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression-free survival (PFS)
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
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.
1 secondary outcome
Overall survival (OS)
Time frame: From date of enrollment until the date of death from any cause, whichever came first, assessed up to 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wei-Chen Lu, M.D. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancers- Squamous Cell and Head and Neck Cancer Metastatic, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hsu Wu, M.D. (+886-3-5326151 ext. 4502, G04187@hch.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026; AzTrials last refreshed its copy on 1 Nov 2026.